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Clinical Research Proposal Process Improvement Project

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University of Washington 
Clinical Research Proposal Process Improvement Project
• Office of Research • Research and Graduate Education, School of Medicine • Health Sciences Administration October 2009

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Clinical Research Proposal Process Improvement Project – Final Report 
Table of Contents I. Project Overview Page 4 A. Genesis of Project Page 4 B. Project Goal/Outcomes/Deliverables Page 4 C. Project Start/End/Boundaries/Assumptions Page 6 D. Project Roles Page 7 II. Project Steps Page 8 A. Project Startup and Kickoff Page 8 B. Investigation, Data Gathering and Documentation Page 8 C. Design Process Changes and Improvements Page 9 D. Make Recommendations and Get Buyoff Page 11 III. Project Deliverables Page 12 A. A Plan for Process Improvements Page 12 B. Clinical Research Handbook Page 14 C. A Plan for an Interim Tracking System Page 15 IV. Post-Project Activities Page 17 A. Action Items for Achieved and Recommended Improvements Page 17 B. End of Project/Post-Project Communication Plan Page 17
   

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Clinical Research Proposal Process Improvement Project – Final Report 
Appendices Appendix A: Project Charter Appendix B: Workgroup Charters Appendix C: Ad Hoc Workgroup Members Appendix D: High-Level Project Steps Appendix E: Process Flowcharts Appendix F: Document/Form Packages Appendix G: Achieved Improvements Appendix H: Recommended Improvements Appendix I: Responsibilities of the Clinical Research Service Center & the Clinical Research Administrator Appendix J: Clinical Research Handbook Analysis Appendix K: Clinical Research Handbook Project Plan Appendix L: Interim Tracking System Presentation Appendix M: Interim Tracking System – Options to Consider Appendix N: Interim Tracking System Key Status Points Appendix O: End of Project Communication Plan
   

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Clinical Research Proposal Process Improvement Project – Final Report 
I. Project Overview
A. Genesis of the Project
Research is the engine that powers the University of Washington (UW). In the biomedical arena, clinical trials are critical to this research mission. Although the UW had attracted substantial research dollars, there was concern that internal work processes hampered UW��s ability to secure funding, especially from industry sponsors. • In the past, UW had experienced an increasing number of industry-sponsored studies that were closed either before negotiations with the sponsor were completed or very soon after the contract was signed and the study opened to enrollment. • The UW and its partners had difficulty in initiating some studies in a timely fashion which meant lost research opportunities, lost revenue, unreimbursed start-up expenses and lost staff effort. • The Cancer Consortium was seeking to expand its solid-tumor cancer research program, especially industry-sponsored studies. Conversations between Mary Lidstrom, Vice Provost for Research, and John Slattery, Vice Dean for Research and Graduate Education in the School of Medicine, over several years focused on how best to facilitate the clinical research proposal process. Because Vice Provost Lidstrom had already made improved staffing, expanded staff training, and process improvements high priorities for units within the Office of Research, Drs. Lidstrom and Slattery agreed to create a partnership whereby both offices would support a cross- organizational, cross-institutional Clinical Research Process Improvement project. Because units of the Office of Environmental Health and Safety played an important role in the clinical research proposal process, the project partnership was expanded to include Kathryn Waddell as a co-Executive Sponsor. In early 2008, the Executive Sponsors asked Richard J. Meisinger, Jr., Assistant Dean in the Office of Research and Graduate Education, to lead a year-long process improvement project. The project kick-off occurred in October, 2008.
B. Project Goal/Outcomes/Deliverables
The project goal, outcomes and deliverables were developed during the first step of the project: project startup. These elements were part of the project charter document which is attached as Appendix A. The project charter document was approved by the Project Executive Sponsors and Steering Committee. Project Goal:
   

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Clinical Research Proposal Process Improvement Project – Final Report 
• For clinical research, reduce the time between the initial submission of the proposal and final approval to enroll patients to 90 days. As the project progressed, words were added to clarify the goal: ��For industry- sponsored clinical research studies, reduce the time between the initial submission of the proposal and final approval to enroll patients to 90 days. For all other clinical research studies, reduce the time between the initial submission of the proposal and final approval to enroll patients.�� Outcomes: • Stakeholders (Principal Investigators, Reviewers, etc.) who participate in the process have knowledge about the complete process and understand their role in the process. • Stakeholders know what needs to happen when. • Stakeholders know who is responsible for what. • Stakeholders know the status of any proposal. • Patients benefit by being able to enroll in clinical studies. Deliverables • A plan for process improvements that reduce the time between initial submission of the proposal and final approval to enroll patients. Process Improvements were made as the project progressed. The plan for process improvements covers those improvements that could not be made during the life of the project due to additional time requirements to make policy changes, negotiate cross-organizational or cross-institutional changes, etc. • A Clinical Research Handbook (��Cookbook��) that includes:
o Process documentation. o Checklists – what activities need to happen when. o Timeline standards. o Definition of roles/responsibilities.
• A plan consistent with the Research Roadmap for a tracking system that monitors status/location of a proposal on the review pipeline. Measurements • Days it takes from the time that the principal investigator submits a proposal until the research study is approved, funded and ready to enroll subjects. Include descriptive statistics such as mean, median and dispersion. • Days it take for approvals within discrete units, e.g. OSP, HSD, Radiation Safety, etc. (including definition of start, stop and suspension times). Include descriptive statistics such as mean, median and dispersion.
   

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Clinical Research Proposal Process Improvement Project – Final Report 
As the project progressed, the Measurement statements were changed to the following: ��Time it takes from when the principal investigator submits a proposal until the research study is approved, funded and ready to enroll subject. Include descriptive statistics such as the man, median, and dispersion.�� ��Time it takes for approvals within discrete units, e.g. OSP, HSD, Radiation Safety, etc. (including definition of start, stop and suspension times). Include descriptive statistics such as mean, median and dispersion.��
C. Project Start/End/Boundaries/Assumptions
Like the project goal, outcomes and deliverables, the Clinical Research process start, end, project boundaries and assumptions were developed during the project startup phase. The purpose of defining the process start and end was to create a common understanding of the span of the process up for review and improvement. Defining boundaries for the process created a common understanding of what could be changed and created strategic points for measuring time. Boundaries arranged by the following categories are included in the Project Charter, Appendix A: • Policies/Procedures/Contracts • Financial • Organizational/Human Resources • Technology • Timeline • Facilities With many stakeholders involved, it��s easy for people to have ideas about what will or will not happen that have not been verbally articulated. The assumptions listed below resulted from Steering Committee discussions during project startup and were also included in the Project Charter. • Project success is dependent upon the cooperation and participation of stakeholders involved in the process. • The purpose of the project is not the elimination of jobs but to improve the efficiency and effectiveness of the process. • The total cost of the process will not be increased. • Creating greater capacity to handle more proposals would be an added benefit, considering the current economic climate, the increase in the number of proposals being submitted and the increased dependence on central offices for support.
   

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Clinical Research Proposal Process Improvement Project – Final Report 
• During this process improvement, we want to focus on the commonalities of proposals (the 90-95%) and not the 5-10% that represents ��exceptions to the rule�� or rare occurrences.
D. Project Roles
Managing an improvement project for a cross-organizational, cross-institutional process required a project structure that included stakeholder involvement across that spectrum. Vertical representation starting with executive sponsorship was also key to the project��s success. The following groups comprised the project structure and met on a regular or ad hoc basis. • Executive Sponsors. The Executive Sponsors chartered the project and provided executive level guidance for the project. The Executive Sponsors met on a bi-monthly basis. See Appendix A for Executive Sponsor membership. • Steering Committee. The Steering Committee was comprised of senior and mid-level managers plus subject matter experts. The Steering Committee��s key role was to grapple with process operational issues, then make decisions about how the process could best work, facilitate staff participation in process improvement work, make decisions and raise policy issues to the Executive Sponsors. The Steering Committee met on a monthly basis. See Appendix A for Steering Committee membership. • Cross-organizational/Cross-Institutional Ad Hoc Workgroups. Several ad hoc workgroups were convened during the course of the year-long project. This approach was based upon a ��hook and un-hook�� strategy of calling the right people together to focus on a part of the process then disbanding the workgroup as soon as their work was completed. Initially four ad hoc workgroups worked on parts of the process that had been identified as high priorities:
o Consent Forms o Radiation Safety/Institutional Biosafety o Implant and Investigational Devices o Interim Tracking System
Each of these workgroups investigated and documented their part of the process, identified areas for improvement and suggested solutions (see Section III). Additionally, an Overall Process workgroup focused on cross-process issues. The charter for each of the five groups is included in Appendix B. Additionally, for parts of the process not already covered, subject matter experts gathered into ad hoc groups (one for each functional area listed below) to accomplish similar work. Team members for each group are listed in Appendix C. • Human Subjects Division (HSD) • Office of Sponsored Programs (OSP)
   

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Clinical Research Proposal Process Improvement Project – Final Report 
• Clinical Research Budget & Billing (CRBB) • Significant Financial Interest (SFI) • Cancer Consortium (CC) • Protocol Office/Scientific Review Committee (SRC) • Project Director, Consultant and Project Manager. Richard Meisinger, Jr., Ph.D, Assistant Dean for Planning and New Initiatives was selected by the Executive Sponsors to direct the project. Laura Walker of The Walker Company was hired to provide the project approach, process improvement methodology, framework and best practices. Ann Wold was hired as Project Manager for the year-long life of the project. These three individuals served as the core team moving the project along on a day-to-day basis.
II. Project Steps
Appendix D lists the following high-level project steps with more detailed tasks under each.
A. Project Startup and Kickoff
During the project startup phase, the Project Director and Consultant met individually with key stakeholders to share background information, collect their input and build support for the project. This input was used to develop the draft project goal, outcomes, and deliverables and was also used to define the process start, end, boundaries and project assumptions. At the kickoff meetings for the Executive Sponsors and the Steering Committee, this draft information was presented to the members. The project documents were then modified and finalized. Additionally, a Communication Plan was developed to carry out a strategy of involving and communicating with as many stakeholders as possible.
B. Investigation, Data Gathering, and Documentation
This was the first time that stakeholders from across the process had the opportunity to come together in a formal way to work on this process. Although stakeholders knew their own piece of the process intimately, there were many questions about how the process worked outside of their area of purview. Even stakeholders who had more of a cross- organizational, cross-institutional view raised many unanswered questions. The ad hoc workgroups provided a forum to raise questions and issues while documenting the process. Key findings from this work included the following: • Stakeholders did not know who owned the process and wanted the ownership defined.
   

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Clinical Research Proposal Process Improvement Project – Final Report 
• The complete cross-organizational, cross-institutional process had not been documented. • In many cases, the process was difficult to graphically represent because so many permutations existed. In some areas, a process did not really exist, it was ad hoc and person dependent. • Principal Investigators (PIs) and Study Coordinators (SCs), especially those inexperienced with the process:
o Were often confused about where to start the proposal process. o Were unsure of what to do when. o Did not necessarily know what materials to put together for whom. o Did not understand the dependencies in the process. o Expressed frustration in not knowing the status of a proposal. o Wished for more knowledge about the process.
• The existing, web-based Clinical Research Handbook contained useful information but was difficult to navigate. • Although some units were collecting metric information (how many, how long, etc.), cross-organizational, cross-institutional baseline data did not exist. • Data being collected existed in at least five different systems. • The status of a proposal could not be tracked across the whole process. The work of the ad hoc workgroups resulted in a set of process flowcharts (Appendix E) that encompass the total process. The set covers the following areas: • Clinical Research Budget & Billing • Radiation Safety (UW & SCCA) • Institutional Biosafety (UW & SCCA) • Implant & Investigational Devices (UWMC & HMC) • Significant Financial Interest • Human Subjects Division/IRBs (UW, CC-IRB, WIRB) • Cancer Consortium
o Protocol Office o Institutional Review Office (IRO)/CC-IRB o Scientific Review Committee
• Office of Sponsored Programs The flowcharts were developed at a medium detail level in order to provide a clear understanding of the process. The flowcharts will be an important component of the Clinical Research Handbook, a tool that can be used to educate process stakeholders.
C. Design Process Changes & Improvements
Documenting the process provided the opportunity to question, redesign and in some cases build segments of the process from the ground up. Across the workgroups a key theme emerged from the conversations: downstream problems in the process were the
   

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Clinical Research Proposal Process Improvement Project – Final Report 
result of key questions not being answered at the front-end of the process. In fact, the ��front-end�� was not acknowledged as the start of the process since each functional area concentrated on the start of their part of the process. This discovery led to asking the following questions: 1. What questions should the PI/SC ask at the front-end? 2. What decision-making needs to occur? 3. Based upon the answers to these questions, what materials should be put together and sent to whom? Figure A
The Walker Company walkercompany@comcast.net
Clinical Trials Process Improvement Project
Downstream Problems Point to Front- End Opportunities Clinical Trials Proposal Process
Start End
Front-end
The first of the above three questions led to defining the following key questions that a PI/SC should ask up-front: 1. Which IRB will the proposal be submitted to? 2. Will a Radiation Safety Review be required? 3. Will an Institutional Bio safety review be required? 4. Will an Implant and Investigational Device review be required? 5. Will the proposal need to be reviewed by the Scientific Review Committee? 6. Will a Significant Financial Interest review be required? Defining and answering the front-end questions proved to be more complex than initially anticipated, especially for Radiation Safety and Institutional Biosafety. Decision-making for these questions is included on the process flowcharts and will be available as part of the Clinical Research Handbook. Answers to the key questions impacted the materials that the PI/SC must put together and deliver (electronically or manually) to numerous organizational units. For example,
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Clinical Research Proposal Process Improvement Project – Final Report 
CRBB required a collection of documents and/or forms in order to develop the study budget/billing grid. HSD required a collection of documents and/or forms in order to submit the proposal to the IRB. Some ��packages�� were required for all studies, e.g. OSP, HSD-IRB while other packages were required based upon study characteristics, e.g. Radiation Safety or Institutional Biosafety. Some documents were common across multiple packages, e.g. the protocol. In all, approximately fourteen possible packages were defined. Like the decision-making required for the key questions, the ��package�� definitions will be included in the Clinical Research Handbook. In this document, they are included as Appendix F. Defining key questions, decision-making and document/form packages was not the only emphasis in making changes and improvements. As the different parts of the process were documented, workgroups looked for the following in order to streamline the process. • Handoffs between offices • Queues • Duplication of effort • Rework
D. Make Recommendations and Get Buyoff
Many improvements did not need to wait until the end of the project to gain the support of the Steering Committee and Executive Sponsors. Decisions regarding these improvements were made during the life of the project and are detailed in Appendix G. They cover many important aspects of the process that impact time and efficiency. Improvements to Specific Parts of the Process 1. Flowcharts of current/optimum process were developed. 2. An online Clinical Research Handbook was conceptualized, designed, planned and is under development. 3. Front-end questions to be answered by the PI/SC were defined. Decision trees to answer questions were developed. Definitions, examples & contacts for consultation will be included in the Clinical Research Handbook. 4. ��Packages�� of required documents/forms based upon answers to the front-end questions were developed. 5. Handoffs and multiple entries of the same data were eliminated. 6. UWMC & SCCA agreed to streamline separate Radiation Safety reviews into one process with a common form. 7. UWMC & HMC agreed to streamline separate Implant and Investigational Device reviews into one process with a common form. 8. Revised account authorizations/electronic funding actions to allow a project to make expenditures for start-up needs before subjects are enrolled in a study.
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Clinical Research Proposal Process Improvement Project – Final Report 
Enabling the Process 9. Executive Sponsors own the process. R. Meisinger is the agent of the Executive Sponsors. 10. A Clinical Research Administrator will be hired to further develop and maintain the Clinical Research Handbook, support the Steering Committee and provide project management support for improvement projects initiated by the Committee. 11. Contacts (individuals) will be identified for each part of the process to help stakeholders navigate the Clinical Research Proposal process. 12. Established process for Study Coordinators to obtain read-only SPAERC access. Management Information/Metrics 13. Status points for each part of the process that are currently collected in organizational unit data systems were identified. Status points have also been identified that are not currently collected but have been cited as being potentially useful status information for stakeholders. Standards 14. Master contract agreements have been and will continue to be developed. 15. Developed internal risk management matrix for clinical trial agreements & reviewed risk management strategies with UW Risk Management Office. Appendix G also indicates whether additional action items need to be accomplished in order to fully implement the improvements. The next section details the improvements that fall into the ��recommended�� category.
III. Project Deliverables
A. A Plan for Process Improvements
Other improvements landed on the ��recommended�� list for some of the following reasons: 1) more discussion was required; 2) additional details needed to be worked out; 3) there was not enough time to implement the change during the formal project; and/or, 4) the improvement had not yet been ranked to determine its priority for implementation. The recommended improvements have been organized into the following five categories. Improvements to Specific Parts of the Process 1. Radiation Safety: Determine whether to start the Radiation Safety review before or after SRC approval.
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Clinical Research Proposal Process Improvement Project – Final Report 
2. Scientific Review Committee: Clarify which study proposals will be reviewed by the SRC. 3. Consent Form: Create a central electronic location where stakeholders can find the most recent version of the Consent Form. 4. Consent Form: HSD is the contact/clearing house for all suggested changes to the Consent Form. 5. Consent Form: HSD does not send proposal applications to WIRB until the Consent Form is completed. 6. Consent Form: Resolve the following questions: 1) When the IRB requests changes in the Consent Form, how best can these be communicated to CRBB so that the budget can be prepared accurately? 2) How can CRBB communicate early enough with HSD about potential incentive payments or subject reimbursements to avoid having the IRB review the Consent Form multiple times? 3) What is the best way to make sure that the Consent Form language is in alignment with the budget & contract? 7. Pricing: Provide required clinical information to hospital service centers so they can generate pricing pages. Establish a central point of distribution for pricing sheet requests. For UWMC, develop a price list that can be used for developing preliminary budgets. 8. Confidentiality Agreements: Establish a formal process for CDAs when institutional signature required. 9. Institutional Biosafety: Have a joint preliminary review when IBC is required at both SCCA & UW then PI can answer all questions at once. 10. Significant Financial Interest: Streamline submission of disclosure letter along with electronic eGC1 & SFI disclosure form. Current submission is manual (to submit electronically requires change in UW confidentiality rules & GIM10 policy); allow SFI review to begin early in the process. 11. Timely submission to IRB for government/foundation proposals. HSD: 1) develops a process to work with the schools/departments so they are notified of ��intent to fund;�� 2) develops a process to work with Grants and Contract Accounting so they are notified when an advance budget is assigned to a proposal; or, 3) publishes a deadline rule specifying the time required to process the proposal application for IRB approval. 12. Subject Injury Billing. Clarify subject injury policies and billing among organizational units (OSP, HSD, CRBB, UW Medicine). 13. UW Human Subjects Injury Compensation Program. Clarify program. 14. Medicare Secondary Payer. Clarify and resolve uncertainties regarding Medicare Secondary Payer issues among organizational units (OSP, AGO, HSD, CRBB). Enabling the Process 15. Design, implement and staff a Clinical Research Service Center that: a. Provides front-end triage support to PIs/SCs. b. Provides status on proposals. c. Helps PIs/SCs navigate the process.
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Clinical Research Proposal Process Improvement Project – Final Report 
d. Coordinates existing training related to the Clinical Research Proposal Process & identifies new stakeholder training needs. See Appendix I for more details on the Clinical Research Service Center Responsibilities. 16. Provide orientation to the Clinical Research Handbook to help PIs/SCs navigate the process. 17. Implement a bi-weekly telecon between OSP & CRBB to share negotiation strategy on proposal applications. 18. Integrate non-industry sponsored clinical trials (federal, foundation, academic and other non-profit) and industry sponsored clinical trials into OSP��s Clinical Trial Group. Management Information/Metrics 19. Encourage each organizational unit to identify, collect and report metrics desired by stakeholders. 20. Acquire a management information system to automate the Clinical Research Proposal Process (out of scope, falls under the Research Roadmap project). Standards 21. For investigator initiated studies, develop standards for protocols. 22. Establish standard naming conventions for the documents being used throughout the process. 23. Establish a name/number for each proposal so it can be referred to in the same way across the process. 24. Develop Intellectual Property language/procedures that are relevant for industry studies. Pre-Proposal Study Merit Evaluation 25. Determine if it is appropriate to perform front-end triage at the departmental level to gauge if a study has sufficient merit to start through the proposal process. 26. To manage proposal workload, establish prioritization guidelines. Appendix H contains background information on each of the recommended improvements including the next step to be taken to move the item forward.
B. Clinical Research Handbook
Prior to the start of this project, the tool available to PIs and SCs was the web-based Clinical Trials Administrative Start-Up Handbook. This handbook was originally developed at the UW School of Medicine to ensure that the administrative start-up process for industry-sponsored clinical trials could be accomplished as quickly and efficiently as
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Clinical Research Proposal Process Improvement Project – Final Report 
possible. Over time the handbook evolved to present information not only about the start-up process but also included other practical information related to clinical research. Although the Handbook contained useful information, it was difficult to navigate and did not reflect the information generated during this Clinical Research Proposal Process Improvement Project. Consequently, the need for a new, regularly updated ��Clinical Research Handbook�� (CRH) was recognized and its design and development is a major deliverable of this project. During the analysis phase of designing the new Handbook, options in the following categories were considered: • Technology. What hardware and software is available and will work best for an online handbook? • Design/Functionality. What approach will allow the user to find the information they want most efficiently? • Content. What information will be most useful to the users? Appendix J provides the detail of the analysis that was presented to the Steering Committee and Executive Sponsors. Discussion and decision-making led to the following approach for the Handbook: • Technology
o Host the CRH on UW Technology servers. o Use Drupal software, an open source, content management system.
• Design/Functionality
o Present information to users in a clear, concise manner while still providing a
depth of information for those who wish to utilize the handbook for more in-depth guidance.
o Provide multiple ways to enter and find information in the handbook. o Use a combination of searchable text pages and navigable process maps. Allow the
user to click on a process activity and access more information. This could be an informational box, link to another website, a contact list, a form, an online document or any other number of informative resources. • Content
o Format information (flowcharts, checklists, decision trees) that has been gathered
as part of the Clinical Research Proposal Process Improvement Project to fit the new Handbook.
o Convert information currently contained in the Clinical Trials Administrative Start-
Up Handbook. Do not convert information that is out of date, inaccurate or has been replaced by information generated during the project. Appendix K, the Project Plan for the Handbook provides additional detail related to technology, design/functionality, content, cost and schedule. The first phase of the CRH is scheduled for a January 2010 release.
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Clinical Research Proposal Process Improvement Project – Final Report 
C. A Plan for an Interim Tracking System
UW does not currently have a system that tracks metric data across the entire Clinical Research Proposal Process. In fact, there are more than five systems that organizational units use for managing their internal processes. Since these systems were not built with the idea of using the data for metrics purposes, organizational units who are reporting metrics have invested considerable time and resources in adapting their systems. In a best case scenario, metric data would be collected across the entire process and be available for two key purposes: 1. To track the number, kind (i.e. industry, government, foundation sponsored), etc. of proposals. 2. To tract the status of a proposal – where it is in the process, time it has spent in each part of the process, etc. Long term, one of the Research Roadmap project��s goals is to implement an automated system for the proposal process that includes the ability to track and report metrics. The analysis for the Clinical Research Proposal Process project focused on the requirements for building and implementing an Interim Tracking System that would fill the gap of a few to several years until the Research Roadmap solution is implemented. The analysis (see Appendix L for details) pointed to several steps that would be required in order to provide process metrics: 1. Identify metric information desired by stakeholders. 2. Identify data points that match the information desired. 3. Determine which data points are currently collected in one of the computer systems. 4. Match the data points desired with data elements in the various systems. 5. Determine a method for extracting the data points from each system. 6. Consolidate the extracted data in one location. 7. Develop a user interface to provide the information to stakeholders. Further investigation revealed that building an Interim Tracking System would require a significant investment of time and resources. Due to the constrained economic climate and budget reductions at UW, it could not be assumed that resources could be dedicated to building the Interim Tracking System. Consequently, moving forward on this project deliverable became one of three options under consideration (see Appendix M). Discussions with the Steering Committee resulted in the modification of the original project deliverable to reflect the realities of the current environment and still assemble building blocks that offer short term benefits, move the organizations toward cross- process measurements and contribute to the longer term Research Roadmap effort. The recommendation is as follows:
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Clinical Research Proposal Process Improvement Project – Final Report 
Encourage each organizational unit to identify, collect and report metrics desired by stakeholders. The following work accomplished during the project will be helpful to the organizational units as they embark on this work. • Systems that contain metric information have been identified. • Using the process flowcharts, data/status points desired by stakeholders have been identified. A summary of the key status points can be found in Appendix N. • Data element information for PIRO/DORA, SAGE/SPAERC/StatusTracker has been collected. Those units with tracking systems already in place (HSD, Cancer Consortium) are sources of advice for those units starting work in this area. This work must be coordinated and interface with the work of the Research Roadmap. The task of making sure this coordination occurs rests with the Steering Committee.
IV. Post Project Activities
A. Action Items for Achieved and Recommended Improvements
Appendices G and H contain more detailed information about the achieved and recommended improvements including the next steps for each item. In the ��next steps�� column, some designations have been used consistently to indicate the status of the achievement or recommendation. These designations include: • Complete. No further action is required. • In progress. The item is currently being worked on. • Ongoing. The item is implemented and will continue to be developed or added to in some way. • Implement. The item can be put into practice as part of the Clinical Research Proposal process. • Steering Committee establishes priority. The Steering Committee will determine the relative priority of this item and determine when work starts on it. This may include decision-making about moving ahead on the item at all. • Start immediately. Next steps on this item should be started shortly after November 1, 2009. • Out of scope. This item is not part of the project. These appendices are the important post-project documents because they detail the work that continues after the formal project end on October 31, 2009 and can be used as the project plan for such.
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B. End of Project/Post-Project Communication Plan
Appendix O, the end of project/post-project communication plan was developed by going through the original project plan and identifying: 1) those stakeholders who should be communicated with at the end or post-project; 2) what information should be conveyed to the stakeholders; and 3) who should convey the information. These communication tasks should begin in November, 2009.

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UNIVERSITY OF WASHINGTON CLINICAL RESEARCH PROPOSAL REVIEW PROCESS IMPROVEMENT PROJECT CHARTER
1
1. NAME OF PROCESS: Clinical Research Proposal Review Process 2. PROJECT ROLES • Executive Sponsors:
o Mary Lidstrom, Vice Provost for Research, o John Slattery, Vice Dean for Research and Graduate Education, School of
Medicine,
o Kathryn Waddell, Executive Director, Health Sciences Administration
• Key Stakeholders ▪ Health Sciences Administration, School of Medicine - Dick Meisinger ▪ Health Sciences Administration, School of Medicine, Clinical Research Budgeting and Billing - Diane Merz ▪ Health Sciences Administration, School of Medicine, Division of Oncology - Sue Hammond/Sonja Stella ▪ Office of Research – Debbie Flores ▪ Office of Research – Jeff Cheek ▪ Office of Research, Human Subjects Division - Karen Moe 1. UW IRB 2. WIRB 3. CC-IRB ▪ Office of Research, Office of Sponsored Programs - Lynn Chronister
o Principal Investigators/Faculty - Dr. Larry Robinson o Cancer Consortium (UW, Fred Hutch, Children��s, Seattle Cancer Care
Alliance) – Marc Provence/Barb Berg
o Environmental Health & Safety - Barbara McPhee
▪ EH&S, UW Radiation Safety Committee - Stan Addison ▪ Institutional Bio Safety Committee - JoAnn Kauffman
o ORIS/SAGE - Darcy Van Patten/Jim Kresl
• Ad Hoc/As Needed Stakeholder Representation
o Cancer Consortium Science Review Committee o UW hospital CFOs o Grants and Contracts Administration [involvement via OSP] o Technology Transfer Office [involvement via OSP] o Attorney General��s Office [involvement via OSP] o Risk Management [involvement via OSP] o Electronic Medical Records (EMR) o SCCA Radiation Safety Committee o Implant & Investigational Device Committees
• Steering Committee
o Dick Meisinger o Diane Merz o Sue Hammond/Sonja Stella o Debbie Flores
APPENDIX A A1

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UNIVERSITY OF WASHINGTON CLINICAL RESEARCH PROPOSAL REVIEW PROCESS IMPROVEMENT PROJECT CHARTER
2
o Jeff Cheek o Karen Moe o Lynne Chronister o Dr. Larry Robinson o Marc Provence/Barb Berg o Barbara McPhee o Stan Addison o JoAnn Kauffman o Darcy Van Patten/Jim Kresl
• Principal Investigators Advisory Group
o Dr. Larry Robinson (liaison from the steering committee) o Dr. Goldberg (Cardiology) o Dr. Sylvia Lucas (Neurology) o Dr. Ajay Gopal (Oncology, from S. Hammond) o Dr. John Thompson (Oncology, from S. Hammond) o Dr. Julie Gralow (Oncology, from S. Hammond) o Rep from international trials
3. PROJECT GOAL/OUTCOMES/DELIVERABLES: • Goal
o For clinical research proposals, reduce the time between the initial
submission of the proposal and final approval to enroll patients to 90 days. • Outcomes
o Stakeholders (Principal Investigators, Reviewers, etc.) who participate in the
process have knowledge about the complete process and understand their role in the process
o Stakeholders know what needs to happen when o Stakeholders know who is responsible for what o Stakeholders know the status of any proposal o Patients benefit by being able to enroll in clinical studies
• Deliverables
o A plan for process improvements that reduce the time between initial
submission of the proposal and final approval to enroll patients
o A Clinical Research Handbook (��Cookbook��)
• Process documentation • Checklists – What activities need to happen when • Timeline standards • Definition of roles/responsibilities • A plan, consistent with the research roadmap, for a tracking system that monitors status/location of a proposal on the review pipeline. • Measurements
APPENDIX A A2

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UNIVERSITY OF WASHINGTON CLINICAL RESEARCH PROPOSAL REVIEW PROCESS IMPROVEMENT PROJECT CHARTER
3
o Days it takes from the time the principal investigator submits a proposal until
the research study is approved, funded and ready to enroll subjects. Include descriptive statistics such as mean, median & dispersion.
o Days it takes for approvals within discrete units, e.g. OSP, HSD, Radiation
Safety, etc. (including definition of start, stop and suspension times). Include descriptive statistics such as mean, median & dispersion. 4. START/END OF PROCESS: Start End A principal investigator initiates a research proposal. Assumption: PI submits a complete proposal. The research study is approved, funded and ready to enroll subjects. Assumption: the PI is able to enroll subjects – that means having a budget number. * 5. BOUNDARIES: • What are the non-negotiable givens that will impact improving this process? • What are some of the known constraints that will impact improving this process and, therefore, must be taken into account? Policies/Procedures/Contracts: In Out • Changing policies & procedures • Changing how contracts are done when acting as the fiscal agent for UW • Policies & procedures mandated by law, e.g. compliance driven Financial: In Out • Project funding for 1 year • Additional funds • Project funding past 1 year Organizational/Human Resources: In Out • Project resources: Project Director, Project Manager, Consultant • Changing staff duties (consistent with the laws & policies that govern HR) • Changing how staff do the work • Changing organizational structure • Identification where staffing is inadequate • Additional project funding • Augmentation to staff in the short term Technology:
APPENDIX A A3

Page 22
UNIVERSITY OF WASHINGTON CLINICAL RESEARCH PROPOSAL REVIEW PROCESS IMPROVEMENT PROJECT CHARTER
4
In Out • May implement a portal tool to track proposals – an interim solution that improves tracking, visibility & status • Changes to the current system if the changes reduce manual movement of paper or eliminate steps • Access to dedicated technology resources • Implementing a new technology system Timeline: In Out • 1 year project timeline • Implementing ��short term fixes�� • Determining resources required for implementation at end of this 1 year project • Implementation of Clinical Research Handbook (��cookbook��) • Project extension beyond 1 year Facilities: In Out • Changing office layout • Changing how paper flows through the physical facilities, e.g. moving paper from one physical location to another, moving physical paper to electronic format • New/different facilities 6. ASSUMPTIONS [What are some of the critical assumptions that will impact the improving this process?] • Project success is dependent upon the cooperation and participation of stakeholders involved in the process. • The purpose of the project is not the elimination of jobs but to improve the efficiency and effectiveness of the process. • The total cost of the process will not be increased. • Creating greater capacity to handle more proposals would be an added benefit, considering the current economic climate, the increase in the number of proposals being submitted and the increased dependence on central offices for support. • During this process improvement, we want to focus on the commonalities of proposals (the 90-95%) and not the 5-10% that represents ��exceptions to the rule�� or rare occurances.
APPENDIX A A4

Page 23
UNIVERSITY OF WASHINGTON CLINICAL RESEARCH PROPOSAL REVIEW PROCESS IMPROVEMENT PROJECT ��CLINICAL RESEARCH PROPOSAL REVIEW PROCESS�� AD HOC WORKGROUP CHARTER
1
1. NAME OF PROCESS: Clinical Research Proposal Review Process 2. PROJECT ROLES • Ad Hoc Workgroup
o Michael Corn, Office of Sponsored Programs o Debbie Flores, Office of Research o Sue Hammond, School of Medicine, Division of Oncology o Diane Merz, Clinical Research Budget & Billing Support Office (CRBB) o Karen Moe, Human Subjects Division o Darcy Van Patten, Office of Research Information Services (ORIS) o Jennifer Yahne, FHCRC Planning and Strategic Development
• Ad Hoc Workgroup Lead
o Lynne Chronister, Office of Sponsored Programs
• Ad Hoc Workgroup Facilitator
o Laura Walker
• Guidance for Ad Hoc Workgroup
o Project Director, Richard Meisinger o Project Manager, Ann Wold
• Oversight for Ad Hoc Workgroup
o Steering Committee
3. PROJECT GOAL/OUTCOMES/DELIVERABLES: • Goal
o Document the current workflow, analyze the complete Clinical Research
Proposal Review process at a high level and make recommendations for improvements. ▪ Define terms to be used commonly across the process. ▪ Define initial submission. ▪ Determine a common numbering system (or a crosswalk system) for proposals that can be used across the process. ▪ Eliminate queues, handoffs, rework and duplication of effort.
o Clarify roles and responsibilities.
• Outcomes
o Stakeholders:
▪ Are using the same terms to refer to the same things. ▪ Know the definition of initial submission and what��s included. ▪ Have a common number for referring to a proposal. ▪ Understand and can navigate the process.
APPENDIX B B1

Page 24
UNIVERSITY OF WASHINGTON CLINICAL RESEARCH PROPOSAL REVIEW PROCESS IMPROVEMENT PROJECT ��CLINICAL RESEARCH PROPOSAL REVIEW PROCESS�� AD HOC WORKGROUP CHARTER
2
• Deliverables
o A process flowchart of the proposed Clinical Research Proposal Review
process.
o A glossary of common terms. o A description of the common numbering system.
• Process Measurements
o Determine process metrics that measure:
▪ The start and finish of the review in each unit plus any suspension periods. ▪ Handoffs, queues, rework and duplication of effort.
o Build into the process a way to collect the measurement data.
4. START/END OF PROCESS: Start End A principal investigator initiates a research proposal. The research study is approved, funded and ready to enroll subjects. 5. BOUNDARIES: • What are the non-negotiable givens that will impact improving this process? • What are some of the known constraints that will impact improving this process and, therefore, must be taken into account? Policies/Procedures/Contracts: In Out • Changing policies & procedures • • Policies & procedures mandated by law, e.g. compliance driven Financial: In Out • • Additional funds Organizational/Human Resources: In Out • Changing staff duties (consistent with the laws & policies that govern HR) • Changing how staff do the work • Changing organizational structure • Identification where staffing is inadequate • Augmentation to staff in the short term Technology: In Out • Use of existing technology • Access to dedicated technology
APPENDIX B B2

Page 25
UNIVERSITY OF WASHINGTON CLINICAL RESEARCH PROPOSAL REVIEW PROCESS IMPROVEMENT PROJECT ��CLINICAL RESEARCH PROPOSAL REVIEW PROCESS�� AD HOC WORKGROUP CHARTER
3
• Changes to the current system if the changes reduce manual movement of paper or eliminate steps resources • Implementing a new technology system Timeline: In Out • • Facilities: In Out • Changing office layout • Changing how paper flows through the physical facilities, e.g. moving paper from one physical location to another, moving physical paper to electronic format • New/different facilities 6. ASSUMPTIONS [What are some of the critical assumptions that will impact the improving this process?] 7. QUESTIONS TO BE ANSWERED • Common language:
o Where does UW vary from national norms? o Where do we disagree on terminology within UW?
• Measuring ��processing�� time:
o What data is required by each unit before the clock begins? o What characterizes a complete review in each unit? o Number of times a staff or formal review committee handles a particular
submission?
o Number of deferrals of action by committees?
APPENDIX B B3

Page 26
UNIVERSITY OF WASHINGTON CLINICAL RESEARCH PROPOSAL REVIEW PROCESS IMPROVEMENT PROJECT ��IMPLANT & INVESTIGATIONAL DEVICES�� AD HOC WORKGROUP CHARTER 1. NAME OF PROCESS: Approval of Implant & Investigational Devices 2. PROJECT ROLES • Ad Hoc Workgroup
o Bill Anton, Program Operations Manager/Operating Room Support Services o Scott Desmond, Compliance Officer/Compliance Office, Harborview Medical
Center
o Barbara Hunziker, Senior Compliance Analyst/Compliance Office,
Harborview Medical Center
o Audrey Lee, Clinical Research Federal Program Operations Specialist,
Clinical Research Budget and Billing Support Office (CRBB)
o Donald Millbauer, Director of Operative Services, Operating Room,
Harborview Medical Center
o Lisa Westlund, Compliance Officer/UWMC Office of Compliance
• Ad Hoc Workgroup Lead
o Richard Meisinger
• Ad Hoc Workgroup Facilitator
o Ann Wold
• Guidance for Ad Hoc Workgroup
o Project Director, Richard Meisinger o Consultant, Laura Walker
• Oversight for Ad Hoc Workgroup
o Steering Committee
3. PROJECT GOAL/OUTCOMES/DELIVERABLES: • Goal
o Document the current roles and responsibilities. o Build an approval process for implant and investigational devices that
integrates the business practices around implant and investigational devices into the overall Clinical Research Proposal Review Process. • Outcomes
o Stakeholders understand the process and their roles and responsibilities
related to the process.
o Under roles and responsibilities, the sequencing of approvals, e.g. between
CRBB and the Implant and Investigational Committee are clearly delineated.
o Medicare policies and procedures are implemented into the proposed
process. • Deliverables
1
APPENDIX B B4

Page 27
UNIVERSITY OF WASHINGTON CLINICAL RESEARCH PROPOSAL REVIEW PROCESS IMPROVEMENT PROJECT ��IMPLANT & INVESTIGATIONAL DEVICES�� AD HOC WORKGROUP CHARTER
o Process flowcharts that incorporate implant and investigational devices into
the overall process. • Process Measurements
o Build into the process a way to measure how long it takes to accomplish the
Implant and Investigational Approval steps.
o Build into the process a way to collect the measurement data.
4. START/END OF PROCESS: Start End Ad Hoc Workgroup defines Ad Hoc Workgroup defines * 5. BOUNDARIES: • What are the non-negotiable givens that will impact improving this process? • What are some of the known constraints that will impact improving this process and, therefore, must be taken into account? Policies/Procedures/Contracts: In Out • Changing policies & procedures • • Policies & procedures mandated by law, e.g. compliance driven Financial: In Out • • Additional funds Organizational/Human Resources: In Out • Changing staff duties (consistent with the laws & policies that govern HR) • Changing how staff do the work • Changing organizational structure • Identification where staffing is inadequate • Augmentation to staff in the short term Technology: In Out • Use of existing technology • Changes to the current system if the changes reduce manual movement of paper or eliminate steps • Access to dedicated technology resources • Implementing a new technology system Timeline:
2
APPENDIX B B5

Page 28
UNIVERSITY OF WASHINGTON CLINICAL RESEARCH PROPOSAL REVIEW PROCESS IMPROVEMENT PROJECT ��IMPLANT & INVESTIGATIONAL DEVICES�� AD HOC WORKGROUP CHARTER
3
In Out • • Facilities: In Out • Changing office layout • Changing how paper flows through the physical facilities, e.g. moving paper from one physical location to another, moving physical paper to electronic format • New/different facilities 6. ASSUMPTIONS [What are some of the critical assumptions that will impact the improving this process?] 7. QUESTIONS TO BE ANSWERED • Can this review happen simultaneously with other aspects of the overall Clinical Research Proposal Review Process?
o Final approval of NIIDR form is dependant upon approval of HSRC
application (?), so these must be done concurrently. • Are there redundant financial reviews (CRBB and Device and Implant committee)?
o What is the financial responsibility of the committee/council? o Financial clearance is necessary part of the process (?)
• As part of the final process, can we implement more standard communication between the relevant offices? • What are the connections to specific research proposals? • Are there any relationships with IRBs? • Is it appropriate to try to apply metrics? • How does the committee/council work?
o What is the membership? o How often do they meet? o Approximately how many requests are handled per year?
• What are the issues with the current process? • Suggestions for improvement?
APPENDIX B B6

Page 29
UNIVERSITY OF WASHINGTON CLINICAL RESEARCH PROPOSAL REVIEW PROCESS IMPROVEMENT PROJECT ��CONSENT FORMS�� AD HOC WORKGROUP CHARTER
1
1. NAME OF PROCESS: Consent Forms Review 2. PROJECT ROLES • Ad Hoc Workgroup
o Arna Elezovic, Human Subjects Division o Karen Hansen, FHCRC Institutional Review Office o Rick Hudson, EH&S, Radiation Safety Office o Jennifer Jones, FHCRC Protocol Office o JoAnn Kauffman, EH&S, Institutional Biosafety o Jason Malone, Institute for Translational Health Sciences (ITHS) o Diane Merz, Clinical Research Budget & Billing Support Office (CRBB) o Adina Robinson, Office of Sponsored Programs
• Ad Hoc Workgroup Lead
o Wendy Brown, HSD
• Ad Hoc Workgroup Facilitator
o Ann Wold
• Guidance for Ad Hoc Workgroup
o Project Director, Richard Meisinger o Consultant, Laura Walker
• Oversight for Ad Hoc Workgroup
o Steering Committee
3. PROJECT GOAL/OUTCOMES/DELIVERABLES: • Goal
o Build a review process for Consent forms that integrates the business
practices around Consent forms into the overall Clinical Review Proposal Review Process.
o Clarify roles and responsibilities.
• Outcomes
o Stakeholders understand and can successfully navigate the Consent Forms
Review process.
o Stakeholders understand what part of the consent form needs to be reviewed
by each unit (clarity roles and responsibilities). • Deliverables
o Process flowcharts that incorporate Consent Form reviews into the overall
process. • Process Measurements
APPENDIX B B7

Page 30
UNIVERSITY OF WASHINGTON CLINICAL RESEARCH PROPOSAL REVIEW PROCESS IMPROVEMENT PROJECT ��CONSENT FORMS�� AD HOC WORKGROUP CHARTER
2
o Build into the process a way to measure the time it takes each unit to review
the Consent Form.
o Build into the processes a way to collect the measurement data.
4. START/END OF PROCESS: Start End Ad Hoc Workgroup defines Ad Hoc Workgroup defines 5. BOUNDARIES: • What are the non-negotiable givens that will impact improving this process? • What are some of the known constraints that will impact improving this process and, therefore, must be taken into account? Policies/Procedures/Contracts: In Out • Changing policies & procedures • • Policies & procedures mandated by law, e.g. compliance driven Financial: In Out • • Additional funds Organizational/Human Resources: In Out • Changing staff duties (consistent with the laws & policies that govern HR) • Changing how staff do the work • Changing organizational structure • Identification where staffing is inadequate • Augmentation to staff in the short term Technology: In Out • Use of existing technology • Changes to the current system if the changes reduce manual movement of paper or eliminate steps • Access to dedicated technology resources • Implementing a new technology system Timeline: In Out • • Facilities: In Out
APPENDIX B B8

Page 31
UNIVERSITY OF WASHINGTON CLINICAL RESEARCH PROPOSAL REVIEW PROCESS IMPROVEMENT PROJECT ��CONSENT FORMS�� AD HOC WORKGROUP CHARTER
3
• Changing office layout • Changing how paper flows through the physical facilities, e.g. moving paper from one physical location to another, moving physical paper to electronic format • New/different facilities 6. ASSUMPTIONS [What are some of the critical assumptions that will impact the improving this process?] 7. QUESTIONS TO BE ANSWERED • Which units currently review consent forms? • What aspect of the consent forms is reviewed by each unit (e.g., patient financial responsibility, relationship to contract language)? • What version (draft #) is being reviewed by each unit? • Which units can require changes in the consent form? • How is the requirement to change a consent form transmitted? To whom? • To which units are modified consent forms sent? • How do units reviewing consent forms communicate with one another?
APPENDIX B B9

Page 32
UNIVERSITY OF WASHINGTON CLINICAL RESEARCH PROPOSAL REVIEW PROCESS IMPROVEMENT PROJECT ��TRACKING�� AD HOC WORKGROUP CHARTER
1
1. NAME OF PROCESS: Interim System to Track Status of Proposal 2. PROJECT ROLES • Ad Hoc Workgroup
o Candy Grossman, Human Subjects Division o Jennifer Jones, FHCRC Protocol Office o Karl Neumann, Office of Sponsored Programs o Sonja Stella, School of Medicine, Division of Oncology o Dorsee Zaballero, Clinical Research Budget & Billing Support Office (CRBB)
• Ad Hoc Workgroup Lead:
o Jim Kresl, Office of Research Information Services (ORIS)
• Ad Hoc Workgroup Facilitator
o Ann Wold
• Guidance for Ad Hoc Workgroup
o Project Director, Richard Meisinger o Consultant, Laura Walker
• Oversight for Ad Hoc Workgroup
o Steering Committee
3. PROJECT GOAL/OUTCOMES/DELIVERABLES: • Goal
o Develop an inventory of tracking systems currently in use. o Develop recommendations for interim approaches that improve the
transparency of tracking.
o Identify issues and challenges that need to be addressed as part of
developing the interim solution.
o Evaluate the interim solution options. Assess cost/benefit, resource
requirements, etc. Channel through any prioritization processes (e.g. roadmap or data consolidation project governance).
o Select interim solution and work with Steering Committee and Executive
Sponsors to secure resources. Note: This shorter term effort does not eliminate the need to perform a complete requirements analysis for a tracking system (associated with the Research Roadmap). It��s to take a look at what can be done in the short term while the longer-term effort proceeds. • Outcomes
o A plan for an interim tracking system that allows:
• Principal Investigators and unit staff to determine the status of a proposal.
APPENDIX B B10

Page 33
UNIVERSITY OF WASHINGTON CLINICAL RESEARCH PROPOSAL REVIEW PROCESS IMPROVEMENT PROJECT ��TRACKING�� AD HOC WORKGROUP CHARTER
2
• Stakeholders to understand the tracking system and their responsibility for maintaining the system. • Deliverables
o Process flowcharts for the Interim Tracking System that include:
• How the system works • How the system is updated • How someone accesses the system to determine the status of a proposal
o Technological infrastructure requirements o Standardized reports, e.g. monthly
• Process Measurements
o Build into the process a way to measure whether or not Principal
Investigators and units are able to determine the status of proposals.
o Build into the process a way to collect the measurement data, e.g. success
rate in determining status of proposal. 4. START/END OF PROCESS: Start End The first time a Principal Investigator submits something that they will want to know the status on. When the Principal Investigator has approval to enroll subjects. * 5. BOUNDARIES: • What are the non-negotiable givens that will impact improving this process? • What are some of the known constraints that will impact improving this process and, therefore, must be taken into account? Policies/Procedures/Contracts: In Out • Changing policies & procedures • • Policies & procedures mandated by law, e.g. compliance driven Financial: In Out • • Additional funds Organizational/Human Resources: In Out • Changing staff duties (consistent with the laws & policies that govern HR) • Changing how staff do the work • Changing organizational structure • Augmentation to staff in the short term
APPENDIX B B11

Page 34
UNIVERSITY OF WASHINGTON CLINICAL RESEARCH PROPOSAL REVIEW PROCESS IMPROVEMENT PROJECT ��TRACKING�� AD HOC WORKGROUP CHARTER
3
• Identification where staffing is inadequate Technology: In Out • Use of existing technology • Changes to the current system if the changes reduce manual movement of paper or eliminate steps • Access to dedicated technology resources • Implementing a new technology system Timeline: In Out • • Facilities: In Out • Changing office layout • Changing how paper flows through the physical facilities, e.g. moving paper from one physical location to another, moving physical paper to electronic format • New/different facilities 6. ASSUMPTIONS [What are some of the critical assumptions that will impact the improving this process?] 7. QUESTIONS • Who needs to have access to the updates? • How frequently must information be updated? • Who is responsible for providing updated information on a regular basis? • Who is responsible for maintaining the tracking system? • What data points and data currently exist that can be incorporated into an interim tracking system?
APPENDIX B B12

Page 35
UNIVERSITY OF WASHINGTON CLINICAL RESEARCH PROPOSAL REVIEW PROCESS IMPROVEMENT PROJECT ��INSTITUTIONAL BIOSAFETY/RADIATION SAFETY�� AD HOC WORKGROUP CHARTER
1
1. NAME OF PROCESS: • Institutional Biosafety approval process • Radiation Safety approval process 2. PROJECT ROLES • Ad Hoc Workgroup
o Lisa Dunnwald, Nuclear Medicine o Steve Johnson, SCCA Biosafety Committee o Karen Moe, Human Subjects Division o Marc Provence, Cancer Consortium o Dr. Lupe Salazar, School of Medicine, Division of Oncology o Sonja Stella, School of Medicine, Division of Oncology
• Ad Hoc Workgroup Co-Leads
o Stanley Addison, EH&S, Radiation Safety Office o JoAnn Kauffman, EH&S, Institutional Biosafety Office
• Ad Hoc Workgroup Facilitator
o Ann Wold
• Guidance for Ad Hoc Workgroup
o Project Director, Richard Meisinger o Consultant, Laura Walker
• Oversight for Ad Hoc Workgroup
o Steering Committee
3. PROJECT GOAL/OUTCOMES/DELIVERABLES: • Goals
o Document the current workflow, analyze and recommend improvements
(short and long term) to the Institutional Biosafety and Radiation Safety processes.
o Clarify roles and responsibilities. o Locate the policies and procedures that impact these processes and provide
as part of the process information.
o Strengthen the Institutional Safety/IRB connection. o Strengthen the Radiation Safety/IRB connection.
• Outcomes
o Stakeholders understand and can successfully navigate the Institutional
Biosafety and Radiation Safety processes. • Deliverables
APPENDIX B B13

Page 36
UNIVERSITY OF WASHINGTON CLINICAL RESEARCH PROPOSAL REVIEW PROCESS IMPROVEMENT PROJECT ��INSTITUTIONAL BIOSAFETY/RADIATION SAFETY�� AD HOC WORKGROUP CHARTER
2
o A process flowchart of the proposed Institutional Biosafety process. o A process flowchart of the proposed Radiation Safety process. o A common data template for IRBs and Radiation Safety Committee.
• Process Measurements
o Build into the process a way to measure the time it takes for a proposal to go
through the Institutional Biosafety process.
o Build into the process a way to measure the time it takes for a proposal to go
through the Radiation Safety process.
o For IBC and Radiation Safety, build into the processes a way to measure the
number of proposals where action is deferred to subsequent Committee Meetings.
o Build into the processes a way to collect the measurement data.
4. START/END OF PROCESS: Institutional Biosafety Start End Ad Hoc Workgroup defines Ad Hoc Workgroup defines Radiation Safety Start End Ad Hoc Workgroup defines Ad Hoc Workgroup defines 5. BOUNDARIES: • What are the non-negotiable givens that will impact improving this process? • What are some of the known constraints that will impact improving this process and, therefore, must be taken into account? Policies/Procedures/Contracts: In Out • Changing policies & procedures • • Policies & procedures mandated by law, e.g. compliance driven Financial: In Out • • Additional funds Organizational/Human Resources: In Out • Changing staff duties (consistent with the laws & policies that govern HR) • Changing how staff do the work • Changing organizational structure • Augmentation to staff in the short term
APPENDIX B B14

Page 37
UNIVERSITY OF WASHINGTON CLINICAL RESEARCH PROPOSAL REVIEW PROCESS IMPROVEMENT PROJECT ��INSTITUTIONAL BIOSAFETY/RADIATION SAFETY�� AD HOC WORKGROUP CHARTER
3
• Identification where staffing is inadequate Technology: In Out • Use of existing technology • Changes to the current system if the changes reduce manual movement of paper or eliminate steps • Access to dedicated technology resources • Implementing a new technology system Timeline: In Out • • Facilities: In Out • Changing office layout • Changing how paper flows through the physical facilities, e.g. moving paper from one physical location to another, moving physical paper to electronic format • New/different facilities 6. ASSUMPTIONS [What are some of the critical assumptions that will impact the improving this process?] 7. QUESTIONS TO BE ANSWERED • What is the nature of the formal communications between the IRBS and IBC? • How do the respective staffs communicate? • Does a PI go directly to the IBC/staff, or is he/she directed by the IRB? • If a research subject potentially can be moved between several clinical facilities, do multiple IBCs need to be involved in the review/approval process? • To which IRB does the Radiation Safety Committee report? • What is the nature of the formal communications between the IRBs and the RSC? • How do the respective staffs communicate? • What is the complimentarity of reviews between UW and SCCA RSCs? • How can the Memorandum of Agreement on the distinction between routine care and research care for studies involving radiation be refined? • Certain kinds of proposals require an NIH/OBA review. Which proposals? How much time does this take? How is the PI notified?
APPENDIX B B15

Page 38
Group_Membership Page 1 Approval of Implant & Investigational Devices Ad Hoc Workgroup Anton, Bill Operating Room Support Services Brown,Wendy Human Subjects Division Desmond, Scott Compliance Office, Harborview Medical Center Hunziker, Barbara Compliance Office, Harborview Medical Center Lee, Audrey Clinical Research Budget and Billing Support Office (CRBB) Millbauer, Donald Operating Room, Harborview Medical Center Robinson, Adina Office of Sponsored Programs Westlund, Lisa UWMC Office of Compliance Clinical Research Proposal Review Process Ad Hoc Workgroup Chronister, Lynn Office of Sponsored Programs Corn, Michael Office of Sponsored Programs Flores, Debbie Office of Research Grossman, Candy Human Subjects Division / Research Hammond, Sue Medicine, Div of Oncology Merz, Diane Clinical Research Budget & Billing Support Office Moe, Karen Human Subjects Division Van Patten, Darcy Office of Research Information Services (ORIS) Consent Forms Review Process Ad Hoc Workgroup Brown, Wendy Human Subjects Division Elezovic, Arna Human Subjects Division Hansen, Karen FHCRC Institutional Review Office Hudson, Rick Radiation Safety Office, Environmental Health & Safety Kauffman, JoAnn Research and Biological Safety Office, Environmental Health and Safety Malone, Jason Dean of Medicine Merz, Diane Clinical Research Budget & Billing Support Office Riddle, James FHCRC Institutional Review Office Robinson, Adina Office of Sponsored Programs Institutional Biosafety/Radiation Safety Ad Hoc Workgroup Addison, Stanley Environmental Health and Safety Hudson, Rick Radiation Safety Office, Environmental Health & Safety Kauffman, JoAnn Research and Biological Safety Office, Environmental Health and Safety Moe, Karen Human Subjects Division Provence, Marc Cancer Consortium, Medicine Stella, Sonja Medicine, Division of Oncology Tracking System Ad Hoc Workgroup Chronister, Lynn Office of Sponsored Programs Kresl, Jim ORIS, Office of Research Merz, Diane Clinical Research Budget & Billing Support Office Moe, Karen Human Subjects Division Stella, Sonja Medicine, Division of Oncology Van Patten, Darcy Office of Research Information Services (ORIS) Zaballero, Dorsee Clinical Research Budget & Billing Support Office
APPENDIX C C1

Page 39
The Walker Company walkercompany@comcast.net
Clinical Research Startup Process High-Level Project Steps
Project Startup
•Develop project framework, goal, scope, outcomes, deliverables, boundaries, priorities •Determine stakeholders •Determine project roles •Develop high- level process charts •Develop communication plan •Collect/develop baseline data •Stakeholder (PI) focus groups
Kickoff Project
•Kickoff with Executive Sponsors •Kickoff with Steering Committee •Finalize project documents •Disseminate initial project communications
Investigation, Data Gathering, Documentation of Current Processes
•Work with ad hoc groups to document & analyze prioritized processes & handoffs •Identify areas for improvement •Work issues, report progress to Executive Sponsors & Steering Committee •Implement communication plan activities
Design Process Changes & Improvements Make Recommendations & Get Buyoff
•Reduce handoffs, queues, duplication from a ��total process�� point of view •Test, pilot potential changes if applicable •Document changes, new processes •Work issues, report progress •Implement communication activities •Communicate & discuss with Executive Sponsors & Steering Committee
Develop Implementation Plan Implement Changes
Longer term
Implement Fast Fixes
Short term
APPENDIX D D1

Page 40
Appendix E  Index of Process Maps  Pages 
Human Subjects Radiation Approval Committee E1 – E3 UW Biosafety Review Process E4 – E7 Implant & Investigational Device Review Process E8 – E10 OSP – Office of Sponsored Programs E11 – E15 Contract Negotiation-Industry Sponsor E11 – E12 Proposal Government E13 – E15 CRBB – Clinical Research Budget and Billing E16 – E25 Budget Prep-Industry E16 – E18 Budget Negotiation-Industry E19 Budget Finalization-Industry E20 – E21 Billing Grid Prep-Non-Industry E22 – E23 Billing Grid Finalization-Non-Industry E24 – E25 UW Human Subject Division (HSD) E26 – E31 UW-IRB E26 – E28 WIRB E29 – E30 CC-IRB E31 Significant Financial Interest (SFI ) Process E32 – E34 Institutional Review Office (IRO)/CC-IRB Process E35 – E38 Protocol Office (PO) Process E39 – E43 Scientific Review Committee (SRC) Process E44 SCCA Biosafety Review Process E45 – E47

Page 41
R1.1 Does the protocol involve radiation therapy/ diagnostic nuclear medical techniques/bone pain therapy administration of internal, external ionizing radiation, and/or imaging? R1.9 Process does not apply No R1.3 Is radiation used in the imaging? Radiation Therapy/ Radiation Diagnostics/ Bone Pain Therapy/ Radiation and Imaging No R1.4 Is this a cancer consortium Study that will be reviewed by the Scientific Review Committee (SRC)? Clinical Care Yes Imaging Only R1.2 Indicate if this is Research or Clinical Care (CC). If CC is indicated, document the decision rationale on the form
FINAL as of 9/1/09
R1.11 Submit form along with SRC application packet to Protocol Office Common Process (Performed by investigator) SCCA Specific Process CommonProcess/Performed at Separate Facilities Key R1.0 Human Subjects Radiation Approval Committee (HSRAC) Process (enter from overall process flow) Yes Yes R1.7 Submit completed form to UW/ HSRAC staff for review R1.5 Is this Research or Clinical Care? No R1.6 Submit completed form and HSRAC packet to UW/ HSRAC staff for review Research R1.8 UW/HSRAC staff concurs that this is CC and does not need HSRAC approval? Yes (Clinical Care, does not require HSRAC review) No (Research, requires HSRAC review) R1.15 R1.10 UW/HSRAC notify PI that they need to submit HSRAC application R1.12 Enter Protocol Office process for SRC PO1.17 R1.13 Enter From Protocol Office process for SRC (SR1.14) R1.14 Complete UW/ HSRAC packet, include SRC approval documents HSRAC Process
Page 1 of 3
Human Subjects Radiation Approval Committee Process
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E1

Page 42
R1.15 At what facility will radiation take place? SCCA R1.16 HSRAC staff determines who should take the lead in the review? UW Med R1.24 UW Med R1.17 UW/HSRAC staff processes application for review SCCA Both R1.18 SCCA/HSRAC staff processes application for review R1.6 R1.19 HSRAC staff reviews application to determine if the study meets the criteria for approval R1.20 Approved by staff? Yes R1.21 Consult with PI/ SC, Scientific Executor (SE), or other experts as necessary No R1.22 Result of consultation Staff Approval R1.23 Return to PI/SC Rejected R1.27 Needs committee review R1.24 Common Process (Performed by Investigator) SCCA Specific Process CommonProcess/Performed at Separate Facilities Key HSRAC Process
Page 2 of 3
FINAL as of 9/1/09
Human Subjects Radiation Approval Committee Process
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E2

Page 43
R1.29 HSRAC performs review Meet to Review R1.20 R1.22 Common Process (Performed by Investigator) SCCA Specific Process CommonProcess/Performed at Separate Facilities Key R1.26 Send approval document to the PI, HSD, IRB and all other applicable offices R1.25 SE and HSRAC Chair sign approval doc R1.27 Send application and any other applicable documents to HSRAC for virtual review R1.28 HSRAC approves via virtual review or chooses to hold a meeting R1.24 Staff writes Approval for SE and HSRAC Chair signature R1.22 Approves via Virtual Committee R1.30 Study approved? Yes R1.31 Return to PI/SC No HSRAC Process
Page 3 of 3
FINAL as of 9/1/09
Human Subjects Radiation Approval Committee Process
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E3

Page 44
B1.1 Does the protocol involve the deliberate transfer of rDNA or DNA or RNA derived from rDNA into human research participants (human gene transfer)? B1.0 Biosafety Review Process (enter from overall process flow) B1.2 Does the project require contact with blood, body fluids, or human tissue processed in a research lab or other non-clinical setting? B1.4 Submit an RPHA to RBSO Yes No No B1.5 Do the research lab or other non-clinical setting handling the blood, body fluids or human tissue and the research team (people) meet all necessary requirements (training, facilities, emergency procedures, etc.) for handling blood, body fluids or human tissue? B1.6 Work with PI to resolve issues for study to procede No Yes B1.3 Process does not apply (rejoin overall process flow) B1.7 Send approval letter to PI (rejoin overall process flow) Yes B2.0 Key to Acronyms: RPHA – Research Project Hazard Assessment Form RBSO – Research and Biological Safety Office BBP – Blood Borne Pathogen OBA - Office of Biotechnology Activities (NIH) RAC - Recombinant DNA Advisory Committee (NIH) IBC – Institutional Biosafety Committee rDNA – Recombinant DNA OBA/RAC process PI process RBSO/IBC process Key
Page 1 of 4
FINAL as of 8/19/09
University of Washington
Clinical Research Proposal Review Process Improvement Project UW Biosafety Review Process
APPENDIX E E4

Page 45
B2.0 Does it involve a vaccine? B3.0 Submit proposal to NIH/OBA following specific submission requirements B3.1 Initial RAC review completed within 15 days (Receive confirmation from OBA of receipt of proposal within 3 days) B2.1 Submit an RPHA to RBSO Yes B2.2 RBSO reviews, concurs with B1.3 & B2.0 decision? B2.5 Yes B3.2 No B2.14 Inform PI that they must submit to NIH/OBA No B2.15 Submit an RPHA to RBSO B1.1 B2.3 Is the submission complete? B2.4 Work with PI to finalize submission No Yes B2.13 Parallel Process OBA/RAC process PI process RBSO/IBC process Key
Page 2 of 4
FINAL as of 8/19/09
University of Washington
Clinical Research Proposal Review Process Improvement Project UW Biosafety Review Process
APPENDIX E E5

Page 46
B3.2 Approved: Yes or needs Public RAC review? B3.3 Public RAC review required (if submitted less than 8 wks before a meeting, deferred until next scheduled review) B3.6 Send approval letter to PI B3.4 Receives approval from public RAC? Letter sent within 10 days) B3.5 Notify PI and IBC of No approval B2.7 Public RAC review No Yes Approval/Yes B2.3 B3.1 B2.15 B2.13 Notify IBC of RAC approval, initiate IBC review B2.6 IBC Subcommittee review B2.5 RBSO forwards to IBC Subcommittee to review, schedules IBC meeting OBA/RAC process PI process RBSO/IBC process Key
Page 3 of 4
FINAL as of 8/19/09
University of Washington
Clinical Research Proposal Review Process Improvement Project UW Biosafety Review Process
APPENDIX E E6

Page 47
B2.6 B2.8 Subcommittee presents to IBC for review and decision B2.10 IBC approval? (meets monthly) B2.12 Notify PI and IRB of rejection No Yes B2.7 Do the research lab, other non-clinical settings, or clinical settings and the research team (people) meet all necessary requirements (training, facilities, emergency procedures, etc.) for handling rDNA? B2.9 Work with PI to resolve issues for study to procede No Yes B2.11 Notify PI and IRB of approval and changes to consent form (rejoin IRB process at H1.15) OBA/RAC process PI process RBSO/IBC process Key
Page 4 of 4
FINAL as of 8/19/09
University of Washington
Clinical Research Proposal Review Process Improvement Project UW Biosafety Review Process
APPENDIX E E7

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D1.1 Is this a device study?
FINAL as of 8/25/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
D1.0 Implant and Investigational Device Review Process (enter from CRBB flow CB2.54 or CB3.33) D1.2 Process does not apply No Yes D1.9 D1.3 Does CRBB Billing Grid indicate the patient accounts will be billed? D1.4 Complete Medicare Part A and Part B IDE approval packets (Noridian packet) D1.5 Will any procedures be performed at HMC? Yes No D1.6 Complete NIIDR form for Surgical Council review Yes D1.7 Complete IDE Intake form No D1.8 Forward all applicable forms to compliance Common Process (Performed by investigator) Compliance Process Key Key to Acronyms: HMC – Harborview Medical Center IDE – Investigational Device Exemption NIIDR – New Implant & Investigational Device Request PFS – Patient Financial Services
Page 1 of 3
Implant and Investigational Device Review Process
APPENDIX E E8

Page 49
D1.9 Receive IDE Intake form/Medicare packets (if applicable)/NIIDR (if applicable) D1.16 D1.10 Are forms accurately and completely filled out? D1.11 Compliance will work the PI or study coordinator to resolve any issues with the forms No D1.8 D1.12 Contact CRBB to begin coverage/ feasibility analysis D1.13 Contact impacted departments for other needed analysis consultation Yes D1.15 Compliance compiles feasibility analysis results from impacted departments D1.14 Forward NIIDR form to HMC for submission to Surgical Council Parallel Processes
Page 2 of 3
FINAL as of 8/25/09
University of Washington
Clinical Research Proposal Review Process Improvement Project Implant and Investigational Device Review Process
APPENDIX E E9

Page 50
D1.17 Investigator notified that the device is authorized D1.19 Compliance submits Medicare packets to Noridian (6 to 8 week turnaround) D1.20 Noridian approves? D1.25 Study on Hold No D1.21 Receive approval letter from Noridian Yes D1.24 Join Overall Process Flow D1.18 Is Noridian approval required? Yes No D1.15 D1.16 Analysis results are favorable? Yes No D1.22 Send copy of letter to PFS, UWP, and study team D1.23 Contact PFS, study team and all other impacted departments to ensure they understand IDE billing process requirements D1.26 PI Notify CRBB to begin budget negotiation (CB2.55)
Page 3 of 3
FINAL as of 8/25/09
University of Washington
Clinical Research Proposal Review Process Improvement Project Implant and Investigational Device Review Process
APPENDIX E E10

Page 51
S1.0 Office of Sponsored Programs (OSP) Process (enter from overall process flow) S1.3 Administrator checks study for the following items requiring additional action: SFI Contract Research Organization (CRO) SFI S1.1 eGC1 routes to OSP from school or college approver S1.2 Senior Administrator assigns to appropriate administrator S1.9 OSP transmits SFI package to Office of Research (OR) enter SFI process SF1.14 CRO S1.4 Administrator negotiates contract (non-Budget) S1.7 Administrator requests Letter of Indemnification S1.5 Agreement on Contract language (may involve escalations within OSP in addition to discussion with process partners)? S1.17 All outstanding issues/items resolved? S1.6 No Clinical Trials Agreement (CTA) S1.10 Enter from SFI process SF1.28 S1.12 Enter from CRBB process CB2.39 S1.14 Enter from applicable IRB Process W1.17 H1.19 CC1.32 No Yes S1.18 S1.11 Cleared for SFI? No S1.15 Applicable IRB approval? Yes No S1.13 Budget negotiated? Yes No S1.8 Letter of Indemnification received? No Yes No Electronic Process Office of Sponsored Programs (OSP) Key Principal Investigator Sponsor Yes Yes S1.16 Cross-check consent form with contract, work with IRB or Sponsor for applicable changes
Page 1 of 2
FINAL as of 8/25/09
University of Washington
Clinical Research Proposal Review Process Improvement Project OSP Process/Contract Negotiation Industry Sponsor
APPENDIX E E11

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S1.17 Electronic Process Office of Sponsored Programs (OSP) Key Principal Investigator Sponsor S1.23 OSP distributes copies to CRBB, P.I. and SOM S1.21 OSP has fully executed contract S1.24 Enter CRBB process CB2.49 S1.22 Issues Electronic Funding Action (EFA) to Grants and Contracts Accounting (GCA) S1.20 Sponsor signs contract (also CRO is applicable) S1.18 PI signs contract as acknowledgement (not approver) S1.19 OSP signs contract
Page 2 of 2
FINAL as of 8/25/09
University of Washington
Clinical Research Proposal Review Process Improvement Project OSP Process/Contract Negotiation Industry Sponsor
APPENDIX E E12

Page 53
S2.0 OSP (Office of Sponsored Programs) Process (enter from overall process flow) S2.1 eGC1 routes to OSP from school or college approver S2.2 Assigned to administrator electronically based on department Electronic Process Office of Sponsored Programs (OSP) Key Principal Investigator Sponsor S2.3 Administrator reviews budget, program announcements, proposal S2.5 Administrator submits proposal and applicable attachments to Sponsor electronically via Grants.gov Yes S2.12 PI receives word from Sponsor receiving notification of a score in the fundable range S2.13 PI submits for Just-in-Time IRB approval process H1.0 CC1.0 S2.4 Does the sponsor use the Just-in-Time IRB approval procedure? S2.6 PI submits for applicable IRB Approval H1.0 CC1.0 No
FINAL as of 8/25/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
Page 1 of 3
OSP Process/Proposal Government
APPENDIX E E13

Page 54
Electronic Process Office of Sponsored Programs (OSP) Key Principal Investigator Sponsor S2.11 OSP receives award notice S2.15 Does study receive JIT - IRB approval? Yes S2.20 S2.14 Enter from JIT IRB Process H1.19 CC1.32 S2.7 Enter from applicable IRB process H1.19 CC1.32 S2.8 Applicable IRB approval? S2.9 Administrator submits proposal and applicable attachments to Sponsor electronically via Grants.gov Yes S2.10 PI receives word from Sponsor receiving notification of a score in the fundable range S2.17 OSP transmits SFI package to Office of Research (OR) enter SFI process SF1.15 S2.16 Administrator checks study for the following items requiring additional action: SFI SFI Parallel Process
Page 2 of 3
FINAL as of 8/25/09
University of Washington
Clinical Research Proposal Review Process Improvement Project OSP Process/Proposal Government
APPENDIX E E14

Page 55
Electronic Process Office of Sponsored Programs (OSP) Key Principal Investigator Sponsor S2.20 Contract Negotiation S2.21 Agreement on Contract language (may involve escalations within OSP in addition to discussion with process partners)? S2.23 OSP signs contract S2.24 Sponsor signs contract S2.26 OSP distributes copies to CRBB, P.I. and SOM CB2.49 S2.25 OSP has fully executed contract Yes No Yes S2.16 S2.22 No CTA No S2.19 Cleared for SFI? S2.18 Enter from SFI process SF1.28 S2.28 Enter CRBB process CB3.32 S2.27 Issues EFA (electronic funding action) to GCA (Grants and Contracts Accounting) and registers with eSNAP (electronic Streamlined Non-Competing Award Process) for NIH awards
Page 3 of 3
FINAL as of 8/25/09
University of Washington
Clinical Research Proposal Review Process Improvement Project OSP Process/Proposal Government
APPENDIX E E15

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CB2.0 CRBB Budget Process (enter from overall process) CB2.1 PI/Study Coordinator (SC) submits materials (paper or electronic) to CRBB – Triage CB2.2 Are Protocol and Consent Form included? CB2.3 Program coordinator creates a folder for the study (electronically and in paper) CB2.8 Program Coordinator sends Project Status Summary Transmittal (PSST) to PI/SC along with email if CTP training isn��t done yet No CB2.4 Place study folder in Triage Bin/ Shared Drive CB2.7 Budget Specialist completes the PSST and places it on the Shared Drive CB2.6 Are the materials complete and ready for review? No Yes CB2.5 Whichever Budget Specialist has ��Triage�� duty that day, retrieves the study folder from the Triage Bin and from the Shared Drive for further analysis CB2.11 Yes Documents required: Final: Protocol, Pricing Pages, CTP Analysis Draft: Consent Form, Contract, DBT, Billing Grid, Sponsor��s Budget, AAA Registration CB2.9 Program Coordinator sends email to PI/SC requesting missing document(s) CRBB process PI process Div Admin or Dept Dir process Key Sponsor process OSP process CB2.10 Program Coordinator assigns to Budget Specialist (based on alpha rotation) Some submissions to CRBB after the initial preparation stage are prompted by notification from OSP, service centers, etc.
Page 1 of 6
CRBB Process Budget Preparation - Industry
FINAL as of 10/23/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E16

Page 57
CB2.12 Budget Specialist begins formal budget review/ preparation CB2.15 CB2.10 CB2.11 Program coordinator sends email to PI/SC to notify them that their study has been assigned and to whom (cc. to Budget Specialist, Div. Admin. or Dept. Dir.) CB2.13 Are there any issues with the documents which require conversation with the PI/SC, HSD, OSP? CB2.14 Budget Specialist communicates with PI/SC, HSD, OSP to resolve issues Yes No CB2.54 Billing Grid enters Implant and Investigational Device process D1.0 (if applicable)
Page 2 of 6
FINAL as of 10/23/09
University of Washington
Clinical Research Proposal Review Process Improvement Project CRBB Process Budget Preparation - Industry
APPENDIX E E17

Page 58
CB2.15 Budget Specialist makes notes about any changes they have made to the DBT and/or Billing Grid CB2.16 Budget Specialist emails revised DBT and/or Billing Grid plus notes to the PI/SC CB2.18 Does PI/SC agree with changes? No Yes CB2.17 PI/SC responds to email. CB2.19 Budget Specialist sends proposed budget to PI/S, Div Admin, or Dept. Dir. and requests approval to negotiate CB2.22 CB2.14 CB2.21 Receive approval from PI/SC to negotiate (if applicable) CB2.20 PI/S, Div. Admin, or Dept. Dir. may ask for a change CB2.55 Notification from PI regarding Device approval (when applicable) enter from D1.26
Page 3 of 6
FINAL as of 10/23/09
University of Washington
Clinical Research Proposal Review Process Improvement Project CRBB Process Budget Preparation - Industry
APPENDIX E E18

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CB2.21 CB2.26 Receive counteroffer from sponsor CB2.27 Review counteroffer and enter into DBT CB2.25 Sponsor accepts budget? Yes CB2.28 Discuss counteroffer with PI/SC CB2.30 Submit new offer to sponsor with PI and Admin approval as appropriate CRBB will give the sponsor 2 days to respond, after which they will send a reminder. CRBB has an escalation process CB2.24 Submit budget to sponsor No CB2.29 PI accepts counteroffer? Yes No CB2.37 CB2.37 CB2.22 Who will be negotiating the budget and payment schedule with the sponsor? CRBB Budget Specialist PI/SC CB2.31 PI/SC negotiates budget w/sponsor may also consult with CRBB CB2.23 Contact sponsor to intro and initiate negotiation This includes sending the proposal either upon initial contact or thereafter. Sometimes will need to input budget into sponsor��s budget tool CB2.32 PI/SC sends negotiated budget to CRBB CB2.33 Budget Specialist reviews docs from PI/SC CB2.34 Are there any issues with the negotiated budget? CB2.35 Resolve issues with PI/SC Yes CB2.36 Receive final budget and payment schedule from PI/SC No CB2.38
CRBB Process Budget Negotiation - Industry
Page 4 of 6
FINAL as of 10/23/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E19

Page 60
CB2.29 CB2.37 Budget Specialist requests final budget and payment schedule from sponsor CB2.38 Final Product: Send out Summary review email to PI/SC, Div. Admin. Or Dept. Dir., etc. CB2.47 Send out Summary review email to: PI/SC Department Administrator CRBB Director CRBB Manager of Program Operations OSP RGE School of Medicine Additionally, if the residual is greater than 25% send a separate communication to ��role�� formerly held by Michael Corn, and RGE Assistant Dean for Planning and New Initiatives (RJM). Need to check for SFI and other CB2.40 Send PI/SC final DBT and request final signed billing grid CB2.41 PI/SC provides budget # & PI signed billing grid CB2.46 Budget Specialist updates DB (future process) to move out of Budget Specialist portfolio and into waiting for final docs Parallel Process CB2.42 Final DBT is password protected CB2.25 CB2.36 CB2.39 Out to OSP process S1.12
Page 5 of 6
FINAL as of 10/23/09
University of Washington
Clinical Research Proposal Review Process Improvement Project CRBB Process Budget Finalization - Industry
APPENDIX E E20

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CB2.46 CB2.42 Program Coordinator creates research account in EPIC CB2.43 Program coordinator request for EPIC template CB2.44 Send pre- implementation packet to PI/SC & hospital service center managers CB2.45 PI/SC can schedule study visits CB2.47 Program coordinator requests final docs from OSP CB2.48 Receive final docs CB2.50 Program coordinator puts docs in queue for final review CB2.51 Budget Specialist performs final review research account registration requires: PI and Study coordinator to complete training Signed CTP checklist Shared EPIC team - hospital Final review cannot be done by same person who performed the initial review Review is to check for agreement between consent, budget and contract CB2.41 CB2.52 Make notes, update DB (future process) with comments CB2.53 File docs CB2.49 In from OSP process S1.24
Page 6 of 6
FINAL as of 10/23/09
University of Washington
Clinical Research Proposal Review Process Improvement Project CRBB Process Budget Finalization - Industry
APPENDIX E E21

Page 62
CB3.0 CRBB Billing Grid Process (enter from overall process) CB3.1 PI/Study Coordinator (SC) submits materials (paper or electronic) to CRBB – Triage CB3.2 Are Protocol (or Study Design) and Consent Form included? CB3.3 Program coordinator creates a folder for the study (electronically and in paper) CB3.8 Program Coordinator sends Project Status Summary Transmittal (PSST) to PI/SC along with email if CTP training isn��t done yet No CB3.4 Place study folder in Triage Bin/ Shared Drive CB3.7 Budget Specialist completes the PSST and places it on the Shared Drive CB3.6 Are the materials complete and ready for review? No Yes CB3.5 Whichever Budget Specialist has ��Triage�� duty that day, retrieves the study folder from the Triage Bin and from the Shared Drive for further analysis CB3.11 Yes Documents required: Final: Protocol, Pricing Pages, CTP Analysis Draft: Consent Form, Contract, DBT, Billing Grid CB3.10 Program Coordinator assigns to Budget Specialist CB3.9 Program Coordinator sends email to PI/SC requesting missing document(s) CRBB process PI process Div Admin or Dept Dir process Key Sponsor process OSP process
Page 1 of 4
CRBB Process Billing Grid Prep – Non-Industry
FINAL as of 10/23/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E22

Page 63
CB3.12 Budget Specialist begins formal billing grid review/ preparation CB3.15 CB3.10 CB3.13 Are there any issues with the documents which require conversation with the PI/SC, HSD, OSP? CB3.14 Budget Specialist communicates with PI/SC, HSD, OSP to resolve issues Yes No CB3.11 Program coordinator sends email to PI/SC to notify them that their study has been assigned and to whom (cc. to Budget Specialist, Div. Admin. or Dept. Dir.) CB3.33 Billing Grid enters Implant and Investigational Device process D1.0 (if applicable)
Page 2 of 4
CRBB Process Billing Grid Prep – Non-Industry
FINAL as of 10/23/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E23

Page 64
CB3.15 Budget Specialist makes notes about any changes they have made to the Billing Grid CB3.16 Budget Specialist emails revised Billing Grid plus notes to the PI/SC CB3.18 Does PI/SC agree with changes? No CB3.17 PI/SC responds to email. CB3.20 CB3.14 Final Billing Grid is password protected Yes CB3.19 Final Product: Send out Billing Grid to PI/ SC and request final signed billing grid
Page 3 of 4
CRBB Process Billing Grid Final – Non-Industry
FINAL as of 10/23/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E24

Page 65
CB3.20 PI/SC provides budget # & PI signed billing grid CB3.25 Update DB (future process) to move out of Budget Specialist work queue and into waiting for final docs Parallel Process CB2.19 CB3.21 Program Coordinator creates research account in EPIC CB3.22 Program coordinator request for EPIC template CB3.23 Send pre- implementation packet to PI/SC & hospital service center managers CB3.26 Program coordinator requests final docs from OSP CB3.27 Receive final docs CB3.28 Program coordinator puts docs in queue for final review research account registration requires: PI and Study coordinator to complete training Signed CTP checklist Shared EPIC team - hospital CB3.24 PI/SC can schedule study visits CB3.29 Budget Specialist performs final review Final review cannot be done by same person who performed the initial review Review is to check for agreement between consent, budget and contract CB3.30 Make notes, update DB (future process) with comments CB3.31 File docs CB3.32 In from OSP process S2.28
Page 4 of 4
CRBB Process Billing Grid Final – Non-Industry
FINAL as of 10/23/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E25

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H1.0 IRB-UW process (enter from overall process or from PO process PO1.22) H1.1 PI/Study Coordinator (SC) submits materials to HSD (paper submission) H1.2 Initial intake by front desk staff: date stamp, data entry, assign to IRB committee H1.3 Are all necessary signatures present? H1.4 Contact PI/SC to obtain signatures/ resolve issues H1.5 IRB staff screens the application to determine if it is ready for full board review and if a consultant is needed. H1.6 Is it ready for full board review? Yes No No Yes H1.7 Administrator assigns to primary reviewer for review and assigns review date, determines if consultant is needed (if not already done in H1.5) H1.9 Provide materials to consultant If necessary engage consultant If necessary engage consultant H1.10 H1.8 Which IRB committee a study is assigned to is mostly random. There are 7 committees (3 behavioral/3 medical/ 1 hybrid), most clinical trials are medical. The exceptions are: Emergency Medicine hESC (human embryonic stem cell research) They are assigned to a specific IRB Is it complete? Is it understandable (college-level lay language)? Are there regulatory issues that have to be incorporated in the full board review? Are there ethical considerations? Advise PI that they need committee reviews: e.g. Radiation Safety, IBC, I & ID, IND, if applicable Each committee has 2-3 staff who support it: Administrator Review Coordinator Program Coordinator General notes about application The ��Packet�� should be: IRB application standard list of attachments : items which are included as attachments as part of the application Items that the researcher has to fill out separately as a template
For the IRB the Protocol is not considered a ��stand-alone�� document, what is transcribed to the IRB application takes precedence over what is in the Protocol
Parallel Process Parallel Process HSD process PI process UW-IRB process Key consultant process H1.28
Page 1 of 3
UW HSD / UW-IRB Process
FINAL as of 9/3/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E26

Page 67
H1.10 Consultant reviews application H1.11 Consultant provides feedback to IRB staff H1.12 IRB staff distributes consultant feedback to committee H1.13 IRB committee members review application H1.14 When necessary primary reviewer contacts PI with questions H1.8 Send application materials to committee members (min 5 days for review) H1.9 H1.7 H1.16 H1.15 Receipt of necessary compliance/ committee reviews Can go through IRB review without these, but will not receive final approval until all have been received HSD process PI process UW-IRB process Key consultant process H1.7 H1.28
Page 2 of 3
UW HSD / UW-IRB Process
FINAL as of 9/3/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E27

Page 68
H1.17 IRB Decision? H1.20 Draft letter to PI, approved by IRB chair H1.21 Send letter to PI Disapproved Tabled H1.22 Staff writes IRB review letter to PI with explanation of requirements for approval, approved by IRB chair, sent to PI Conditional approval Deferral H1.23 PI responds to requirements Conditional Approval H1.18 Email to PI with approval Approved H1.24 Intake: date stamp, data entry Deferral H1.15 Conditional approval items do not require full committee approval, they can go to a single IRB reviewer, or can be determined that they do need to go back for committee review. H1.26 Route to Primary Reviewer of original reviewing IRB H1.27 Primary Reviewer approves? Yes No H1.28 Put on schedule for next meeting of original reviewing IRB H1.16 IRB meeting is held: includes discussion of PI comments and committee review H1.25 Put on schedule for next meeting of original reviewing IRB HSD process PI process UW-IRB process Key consultant process H1.19 Send approval docs to PI, application with chair��s signature (enter S1.14 or S2.7 or S2.14) also enter PO1.25 H1.7
Page 3 of 3
UW HSD / UW-IRB Process
FINAL as of 9/3/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E28

Page 69
W1.0 HSD-WIRB process (enter from overall process or from PO process PO1.21) W1.1 PI/Study Coordinator (SC) submits materials to HSD (electronically) W1.5 HSD Compliance Analyst prints materials and gives to HSD Front Desk Staff Yes No W1.7 Front desk scans coversheet, consent form sends to PI/SC W1.3 HSD Compliance Analyst screens document to verify if eligible for WIRB submission and UW requirements are met W1.6 Initial intake by front desk staff: data entry, assign to IRB committee – mark ��W�� for WIRB W1.10 Enter WIRB review process W1.8 PI submits application to WIRB HSD (not acting as UW-IRB) Receive via PDF or MS word attachments Email to hsdinfo@u.washington.edu W1.2 HSD Compliance Analyst monitors email account for new submissions (backup is HSD Assistant Director for Quality & Compliance) Print: WIRB Cover Sheet (sign) Consent Form (stamp) Confidentiality Agreement (sign) Consent Form receives UW Stamp to show that compensation language has been screened (Analyst acting as UW-IRB rep) Also send: electronically to CC-Protocol Office for applicable Oncology studies Paper to UW-Radiation Safety (regardless of RS involvement) HSD process PI process WIRB process Key W1.4 Contact PI/SC with instructions (join applicable IRB process) UW-IRB process W1.9 WIRB notifies HSD (electronically) that application has been received
UW HSD / WIRB Process
Page 1 of 2
FINAL as of 9/3/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E29

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W1.14 WIRB sends email w/ attachments to HSD (certificate of approval, regulatory letter) Yes W1.11 Enter from WIRB review process W1.12 Study approved? No W1.15 Review compensation language on consent form, approved? W1.16 Forward email to HSD admin asst language approved W1.18 HSD Compliance Analyst contacts PI/SC and/or WIRB to initiate changes language not approved W1.19 PI/SC make changes to consent form, send to HSD and/ or WIRB W1.21 Enter WIRB review process W1.20 PI submits modification or amendment to consent form to WIRB Begin 3 day ��hold�� period, only applies to initial applications. If HSD does not contact WIRB then the docs are released to the PI/ SC WIRB moving to authenticated portal access Usually the SC will contact the sponsor about changing the language W1.17 Admin Asst performs data entry and stores docs electronically (rejoin overall process) enter S1.14 and PO1.24 HSD process PI process WIRB process Key UW-IRB process W1.13 Study does not take place
Page 2 of 2
UW HSD / WIRB Process
FINAL as of 9/3/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E30

Page 71
C1.0 HSD/CC-IRB process (enter from PO process PO1.23) C1.1 Protocol Office submits signed coversheet to HSD (electronically) C1.5 HSD Compliance Analyst signs coversheet and submits to HSD Front Desk Staff Yes No C1.6 Scan coversheet and send electronically to PI/SC and Protocol Office C1.3 HSD Compliance Analyst screens document to verify CC-IRB submission C1.8 Enter CC-IRB review process PO1.26 C1.7 PI submits application to CC- IRB (via Protocol Office) Print and date stamp CC-IRB Cover Sheet Also send: Paper to UW-Radiation Safety (regardless of RS involvement) C1.2 Initial intake by front desk staff: date stamp, data entry, assign to IRB committee – mark ��C�� for CC-IRB Authorization that study is ok to be reviewed by CC-IRB HSD process PI process Protocol Office process Key C1.4 Contact PI/SC with instructions (join applicable IRB process)
UW HSD / CC-IRB Process
Page 1 of 1
FINAL as of 9/3/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E31

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Significant Financial Interest (SFI) Process
FINAL as of 8/26/09
SF1.0 SFI process (enter from Overall process) SF1.2 PI/SC indicate ��yes�� on eGC1 SF1.9 SF1.1 Does any ��investigator�� involved with the study have SFI? Yes SF1.3 PI/SC complete SFI disclosure form and write confidential disclosure letter SF1.4 PI/SC send SFI disclosure form and disclosure letter (letter enclosed in sealed envelope) to department SF1.5 PI/SC indicate ��no�� on eGC1 SF1.6 Rejoin Overall process No SF1.7 Department signs SFI disclosure form (disclosure letter remains enclosed in sealed envelope) Department process PI process School process Key OSP process OR process RGE process ��Investigator�� for this purpose is defined broadly as anyone involved with the study The PI is responsible for assuring that any ��investigator�� with SFI submits the proper paperwork The following questions are intended to help determine whether an investigator in a clinical trial might have a Significant Financial Interest (SFI). Please note that SFI��s do not include any salary paid by the UW even if the salary is included in the clinical trial budget paid by the sponsor. 1. Have you received any form of personal compensation from the sponsor of the trial (such as consulting fees, honoraria or travel reimbursement) within the last year or do you anticipate receiving such compensation while the trial is ongoing? 2. Do you own any stock or other equity interest in the sponsor of the trial? 3. Do you have any other personal financial interests relating to the sponsor of the trial? 4. Do you have any personal financial interest in any other company whose product competes with a product being evaluated in the trial? 5. Do you have any IP interest related to the product being evaluated in this trial? 6. Would any of your immediate family members answer ��yes�� to the above questions? If an investigator answers ��yes�� to any of these questions, the investigator may be required to disclose a financial interest and have a review as required by Grants Information Memorandum No. 10 (GIM 10), the University��s Significant Financial Interest Disclosure Policy. Any investigator answering ��yes�� to any of these questions should review GIM 10, http://www.washington.edu/research/osp/gim/ gim10.html, and obtain advice on whether the investigator is required to submit a Significant Financial Interest Disclosure Form with the Form eGC1 for the trial. SF1.8 Department sends SFI disclosure form (disclosure letter remains enclosed in sealed envelope) to school
Page 1 of 3
FINAL as of 8/26/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E32

Page 73
SF1.16 SF1.11 OSP reviews to assure that file is complete SF1.8 SF1.9 School signs SFI disclosure form (disclosure letter remains enclosed in sealed envelope) SF1.10 School contacts PI/SC and arranges for docs to be sent to Office of Sponsored Programs (OSP) SF1.12 OSP flags trial (in SPAERC) for SFI and puts on ��hold�� SF1.14 OSP transmits to Office of Research (OR) for review (S1.9) SF1.18 Courtesy notification to RGE Vice Dean SF1.13 Industry Sponsor? Yes SF1.15 OSP transmits to Office of Research (OR) for review upon notification of intent to fund (S2.17) No SF1.16 Department process PI process School process Key OSP process OR process RGE process
Page 2 of 3
Significant Financial Interest (SFI) Process
FINAL as of 8/26/09 FINAL as of 8/26/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E33

Page 74
SF1.22 OR reviews SFI documents SF1.14 SF1.16 Is this a SOM project? Yes No SF1.17 Send to Vice Dean for RGE for SFI review SF1.18 RGE reviews SFI documents SF1.20 RGE writes memo recommending how to manage SFI SF1.21 RGE transmits memo to OR along with all supporting documents Department process PI process School process Key OSP process OR process RGE process SF1.15 SF1.19 Any additional information needed from PI/SC? No Yes SF1.23 Any additional information needed from PI/SC? SF1.24 OR makes determination about how to deal with SFI and writes management plan SF1.25 OR notifies PI/SC, OSP, IRB and all other relevant parties of management plan, marks approval in SPAERC SF1.27 OSP release ��hold�� SF1.26 Enter UW-IRB process (if applicable) at H1.15 SF1.28 Enter OSP process at S1.10 or S2.18 No Yes Possible ways to deal with SFI Eliminate Reduce Manage what is the role of that ��investigator�� and how does it impact the study Don��t approve SF1.9
Page 3 of 3
Significant Financial Interest (SFI) Process
FINAL as of 8/26/09 FINAL as of 8/26/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E34

Page 75
CC1.0 IRB-CC process (enter from protocol office process PO1.30) CC1.1 Protocol Office (PO) submits materials to IRO CC1.2 Initial intake: assign unique IR #, date stamp, log into PIRO, assign to IRB committee analyst CC1.3 IRB staff screens the application to determine if all docs are present and for content. CC1.6 Does the IRB require a consultant? CC1.27 Engage a consultant and alert IRB chair CC1.4 Is application complete and accurate? CC1.5 IRB Staff communicate to PI with cc: to PO to resolve issues No Yes CC1.7 Forward application to an expedited reviewer (typically the chair of the committee) if necessary engage consultant CC1.28 CC1.8 Parallel Process There are 3 IRB committees, CC-IRB committees are Committees A & B Each IRB Committee has 1 analyst and 1 admin staff, they will share the workload with other IRB committees when necessary A particular study may be assigned to a particular IRB (A or B) dependent on expertise, but is typically assigned to the IRB with the next upcoming meeting (each meets 1/per month) Review takes from 3 to 8 hours, dependent on getting questions answered, or potentially a supplemental form, email is preferred method For consultants outside of the UW or CC this is done by the IRO Director/ for consultants within it is done by the IRO Assistant Director consultant process PI process Protocol Office process Key CC-IRB process
Page 1 of 4
IRO / CC-IRB Process
FINAL as of 7/9/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E35

Page 76
CC1.11 Send back to analyst CC1.28 Provide materials to consultant CC1.29 Consultant reviews application CC1.30 Consultant provides feedback to IRB analyst CC1.31 IRB analyst posts consultant feedback to eReview. Consultant may also participate in meeting in- person or via teleconference CC1.12 Analyst schedules for next IRB committee meeting, posts to eReview (min 1 week prior to mtg) CC1.14 Are there questions of the PO or PI? CC1.16 IRB meeting is held: includes discussion of PI comments and committee review CC1.8 Can the application be expedited? CC1.9 Expediter signs application (paper) sends back to analyst Yes No CC1.13 Committee members review documents CC1.15 Analyst contacts PO or PI with questions, posts Q &A on eReview Yes No CC1.27 CC1.7 CC1.17 CC1.26 CC1.26 CC1.24 Analyst tasks Create agenda Organize documents for review Data entry Scan documents in preparation for posting to eReview Email alert CC1.12 Committee reviews up to 5 new studies per meeting, in addition to continuations, modifications, non- compliance issues, etc. PI may participate in the meeting if invited by the committee CC1.16 Consultant required to sign a conflict of interest per study CC1.10 IRB staff stamps approval documents & ships back to PO, PO1.31 consultant process PI process Protocol Office process Key CC-IRB process
Page 2 of 4
IRO / CC-IRB Process
FINAL as of 7/9/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E36

Page 77
CC1.17 IRB Decision? Disapproved w/major mods CC1.18 Send letter to PO outlining results of meeting Approved w/minor mods CC1.19 PO communicates to PI Approved as submitted CC1.20 PI makes modifications and/ or secures approvals CC1.21 PI sends new package with modifications and/ or approvals to PO CC1.16 CC1.22 CC1.9 CC1.26 CC1.12 CC1.24 CC1.26 CC1.11 Approved as submitted all committee approvals must be there Signed contract (fully executed CTA) or Grant. Office of General Council has approved consent form (only applies to Industry Sponsored research with a CTA) This type of approval does not happen often with new studies Approved with minor modifications required Missing regulatory committee approval (e.g. Radiation Safety, Biosafety) Does not have fully executed CTA Committee required minor changes (��simple concurrence��) Disapproved with major modifications Generally requires big changes Goes through full review Unknowns that go beyond ��simple concurrence�� Protocol Office is likely screening to assure IRB comments have been addressed IRO keeps all original IRB documents Docs to PO only if they were involved, otherwise directly to PI CC1.32 Documents are released within 48 hours: Copy of signed application goes back to protocol office PO1.31 consultant process PI process Protocol Office process Key CC-IRB process
Page 3 of 4
IRO / CC-IRB Process
FINAL as of 7/9/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E37

Page 78
CC1.22 PO sends package to IRO analyst CC1.23 Analyst performs new regulatory review CC1.26 Expediter finds PI��s response to letter acceptable? Acceptable Not acceptable CC1.24 Was it disapproved the last time it was reviewed? Yes No CC1.21 CC1.25 Analyst sends to expedited reviewer CC1.9 CC1.11 CC1.12 General notes about the IRB The FHCRC-IRB also serves as the CC-IRB. The IRB oversees approximately 1,200 open protocols, approximately 10% (150) of those are specific to the CC-IRB. The IRB processes about 250 new applications per year, approximately 10% of those are for the CC-IRB (not all of which require full committee review – reference to the max of 5 new protocols on each meeting) It is rare for studies to go directly to the IRO without first going through the Protocol Office The IRO will do pre-screening of applications prior to Protocol Office submission when asked. The process for the IACUC (also administered by the IRO) is very similar to the process for the IRB IRB committees will review applications that have not yet received approval from other regulatory committees (e.g. Radiation Safety), except for the Scientific Review Committee – they require SRC approval prior to review. This requirement applies only to CC-IRB, not all reviews conducted by FHCRC IRB require SRC review. If it is determined that the study must go through full committee review again, it is assigned to the same committee that did the original review consultant process PI process Protocol Office process Key CC-IRB process
Page 4 of 4
IRO / CC-IRB Process
FINAL as of 7/9/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E38

Page 79
PO1.2 Process does not apply PO1.0 Protocol Office Process (enter from Overall process flow) PO1.1 Does my trial fit into any of the following categories: Category A: Clinical Research Division Study or Cancer Consortium Study Category B: Intervention Public Health Sciences Study, Seattle Children��s intervention study or Puget Sound Oncology Consortium Study PO1.7 Neither A or B PO1.3 Submit via Protocol Office, but process not covered in this document Category B Category A PO1.4 Prepare and submit the following documents to the Protocol Office (PO) CC submission checklist UW coversheet IRB application form (optional) Protocol Consents Synopsis (if applicable) Assent (if applicable) Investigator��s Brochure (if applicable) PO1.5 Initial document review by FHCRC Protocol Office PO1.6 Are changes or additional documents required? Yes No Common Process (Performed by investigator) FHCRC Protocol Office Key
Page 1 of 5
University of Washington
Clinical Research Proposal Review Process Improvement Project Protocol Office Process
FINAL as of 7/17/09
APPENDIX E E39

Page 80
Common Process (Performed by investigator) FHCRC Protocol Office Key PO1.7 Will CC-IRB, WIRB or UW-IRB be used? PO1.8 Assign CC-IRB protocol number PO1.10 Assign WIRB protocol number CC-IRB WIRB Scientific Review Committee (SRC) PO1.9 Assign UW- IRB protocol number UW-IRB PO1.6 PO1.13 PO1.11 Protocol Review Coordinator (PRC) records basic data in PIRO PO1.12 PRC forwards CC Submission Checklist to Data Entry Coordinator (DEC) for additional data entry
Page 2 of 5
University of Washington
Clinical Research Proposal Review Process Improvement Project Protocol Office Process
FINAL as of 7/17/09
APPENDIX E E40

Page 81
PO1.14 Is this a non-intervention study (information is gathered but not used to affect the outcome of the research subject, nor is the impact of the information gathering process itself assessed)? Yes No PO1.13 Is trial to be implemented by consortium members at FHCRC, UW, CHRMC Or FHCRC, UW, CHRMC investigators enrolling SCCA patients in trials Yes No PO1.12 PO1.15 Is this a Community intervention trial? (involves the enrollment of groups or communities of subjects). Although the subjects in the groups may be individually identified, the group or community constitutes the experimental unit for purposes of intervention and evaluation. Yes No PO1.16 PO1.19
Page 3 of 5
University of Washington
Clinical Research Proposal Review Process Improvement Project Protocol Office Process
FINAL as of 7/17/09
APPENDIX E E41

Page 82
PO1.15 PO1.17 Enter Scientific Review Committee Process SR1.0 PO1.14 PO1.18 Enter from SRC process SR1.9 PO1.22 PI submits app to UW- HSD H1.0 PO1.21 PI submits docs to UW- HSD W1.0 UW-IRB WIRB PO1.25 Enter from UW-HSD process H1.19 PO1.24 Enter from UW-HSD process W1.17 PO1.30 PO1.37 PO1.41 PO1.19 Which IRB? PO1.16 Is this a FH- CRD trial? PO1.20 Enter Clinical Investigator��s Meeting Process Yes No PO1.23 Protocol Office submits coversheet to UW-HSD C1.0 PO1.26 Enter from UW-HSD process C1.8 CC-IRB PO1.27 Prepare documents for IRO submission PO1.28 Data Entry Coordinator (DEC) enter data in PIRO PO1.29 Data Entry Coordinator (DEC) enter data in PIRO
Page 4 of 5
University of Washington
Clinical Research Proposal Review Process Improvement Project Protocol Office Process
FINAL as of 7/17/09
APPENDIX E E42

Page 83
PO1.27 PO1.28 PO1.29 PO1.32 Data Entry Coordinator (DEC) enter data in PIRO PO1.34 PRC loads study documents to FYI website PO1.33 DEC forward documents to FYI coordinator PO1.35 Approved study documents are submitted to PDQ PO1.36 File hard copy PO1.37 Funding approved? Yes PO1.39 Enter Data No PO1.40 Protocol never activated PO1.30 Protocol Office submits to IRO for CC-IRB review CC1.0 PO1.31 Enter from CC-IRB process CC1.10 or CC1.32 PO1.41 Funding approved? PO1.42 Enter Data Yes PO1.45 Enter Data No PO1.46 Protocol never activated PO1.38 Enter Data PO1.43 DEC forward documents to FYI coordinator PO1.44 PRC loads study documents to FYI website
Page 5 of 5
University of Washington
Clinical Research Proposal Review Process Improvement Project Protocol Office Process
FINAL as of 7/17/09
APPENDIX E E43

Page 84
Scientific Review Committee Process
Common Process (Performed by investigator) FHCRC Protocol Office Key SR1.1 Process documents for the Scientific Review Committee (SRC) SR1.5 SRC decision SR1.6 PI Revisions SR1.10 PI Revisions SR1.8 SRC approval documents generated SR1.7 Individual SRC reviewer decision Approved Not approved or Major Revision Requested Minor Revision Requested Scientific Review Committee (SRC) SR1.9 Rejoin Protocol Office process PO1.18 SR1.3 SRC concurs that this is CC (does NOT need Radiation Safety Review) or disagrees and determines that it is Research and DOES need Radiation Safety Review) SR1.2 Full SRC Review No (Research) CC SR1.4 Enter Radiation Safety Review Process R1.13 via Protocol Office Parallel Process SR1.0 Scientific Review Committee Process (enter from Protocol Office process PO1.17 or CIM process)
Page 1 of 1
University of Washington
Clinical Research Proposal Review Process Improvement Project
FINAL as of 7/17/09
APPENDIX E E44

Page 85
SCCA Biosafety Review Process
SB1.1 Does the protocol involve the deliberate transfer of rDNA or DNA or RNA derived from rDNA into human research participants (human gene transfer)? SB1.0 Biosafety Review Process (enter from overall process flow) SB1.2 Does the project require contact with blood, body fluids, or human tissue processed in a research lab or other non-clinical setting? Yes No No SB1.3 Process does not apply (rejoin overall process flow) Yes SB1.8 Key to Acronyms: OBA - Office of Biotechnology Activities (NIH) RAC - Recombinant DNA Advisory Committee (NIH) IBC – Institutional Biosafety Committee rDNA – Recombinant DNA BSO – Biological Safety Officer OBA/RAC process PI process RIO/IBC process Key SB1.4 Contact FHCRC EH & S for lab and personnel safety requirements SB1.5 This human study involves the induction or enhancement of an immune response to a vector-encoded microbial immunogen as the major goal, and such an immune response has been demonstrated in model systems,and the persistence of the vector-encoded immunogen is not expected? SB2.0 Submit proposal to NIH/OBA following specific submission requirements SB2.1 Initial RAC review completed within 15 days (Receive confirmation from OBA of receipt of proposal within 3 days) No Yes SB2.2 Approved: Yes or needs Public RAC review? Public RAC review SB2.3 Approval/Yes SB2.7
Page 1 of 3
FINAL as of 8/25/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E45

Page 86
SB2.3 Public RAC review required (if submitted less than 8 wks before a meeting, deferred until next scheduled review) SB2.7 Send approval letter to PI SB2.4 Receives approval from public RAC? Letter sent within 10 days) SB2.6 Notify PI of No approval No Yes SB2.2 SB1.5 OBA/RAC process PI process RIO/IBC process Key SB1.8 Complete the Institutional Biosafety Committee (IBC) Clinical Trial Review Submission Form and IBC application packet: Protocol and amendments Investigator��s Brochure Consent Form(s) FDA Form 1572 Biographical sketch(es) and CV(s) Appendices M and supporting documentation SB2.2 SB2.5 Send approval letter to PI SB1.6 Include for IBC submission (SB1.8): PIs response to RAC recommendations made during public review meeting SB1.7 Include for IBC submission (SB1.8): RAC-Sponsor/PI correspondence pertaining to this gene transfer product and clinical trial SB1.9
Page 2 of 3
SCCA Biosafety Review Process
FINAL as of 8/25/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E46

Page 87
SB1.8 SB1.14 IBC review and decision (meeting scheduled as needed) SB1.15 Decision? SB1.16 Notify PI of rejection SB1.11 Work with PI to resolve issues for study to procede Yes SB1.17 Notify PI of approval via IBC approval letter (rejoin overall process) OBA/RAC process PI process RIO/IBC process Key SB1.9 Submit the IBC Clinical Trial Review Submission Form and IBC application packet to RIO SB1.10 Application complete and ready for IBC review? No SB1.12 Submit to 2 primary reviewers for preliminary review Denied Approved Conditional Approval SB1.21 Needs full committee review? Yes No SB1.20 Review by 2 primary reviewers, IBC Chair and Biological Safety Officer SB1.13 Distribute materials to full committee SB1.18 Send PI approval pending response letter SB1.19 PI responds to committee��s concerns
Page 3 of 3
SCCA Biosafety Review Process
FINAL as of 8/25/09
University of Washington
Clinical Research Proposal Review Process Improvement Project
APPENDIX E E47

Page 88
eGC1
Initiated by: 
Industry Non-UW Investigator UW Investigator Non-UW Investigator Government
Sponsored (Funded) by: 
Industry Dept Government / Non-Profit
Form Name 
Protocol R R R NA OE OE OE Consent Form R R R NA OE OE OE Contract R R R NA R* R* R* Budget (Sponsor��s) R R R NA NA NA NA SFI GIM-10 Disclosure Form (Manual Process) R R R R R R R 1 of 3 (whichever applies) IRB Application IR IR IR NA IR IR IR IRB Application – WIRB IR NA NA NA NA NA NA IRB Application – CC IR IR IR NA IR IR IR eGC1 R R R NA R R R Grant NA NA NA NA R R R
* Contracts are required when the sponsor requires one, some government awards and some non-profit awards have contracts and others do not.
APPENDIX F F1

Page 89
CRBB
Initiated by: 
Industry Non-UW Investigator UW Investigator Non-UW Investigator Government
Sponsored (Funded) by: 
Industry Dept Government / Non-Profit
Form Name 
Protocol R R R NA NA NA NA Study Design NA NA NA R R R R Consent Form R R R R R R R Contract R R R NA NA NA NA Budget (Sponsor��s) R OE OE NA NA NA NA Budget (Coordinating Center��s) NA OE NA NA NA OE NA Clinical Trials Policy Analysis Checklist R R R R R R R AAA Packet w/Pricing Pages R R R R R R R Draft Detailed Budget Tool R R R O O O O Billing Grid Funding Letter R R R R R R R NA NA NA NA R R R
AAA Packet 
Initiated by: 
Industry Non-UW Investigator UW Investigator Non-UW Investigator Government
Sponsored (Funded) by: 
Industry Dept  Government / Non-Profit
Form Name 
Clinical Trial Planning and Implementation Form (CTPI) WA WA WA WA WA WA WA AAA (Account) Registration Form R R R R R R R UW Pricing Pages WA WA WA WA WA WA WA HMC Pricing Pages WA WA WA WA WA WA WA Cost Center or Service Center Specific Forms WA WA WA WA WA WA WA
APPENDIX F F2

Page 90
Research Implementation Office (RIO) �� SCCA 
Initiated by: 
Industry Non-UW Investigator UW Investigator Non-UW Investigator Government
Sponsored (Funded) by: 
Industry Dept  Government / Non-Profit
Form Name 
Protocol R R R OE OE OE OE Investigator��s Brochure WA WA WA WA WA WA WA Instructions for Use (Device) WA WA WA WA WA WA WA Consent Form R R R R R R R Clinical Trials Policy Analysis Checklist R R R R R R R Clinical Trial Planning and Implementation Form (CTPI) R R R R R R R
APPENDIX F F3

Page 91
WIRB 
Initiated by: 
Industry Non-UW Investigator UW Investigator Non-UW Investigator Government
Sponsored (Funded) by: 
Industry Dept  Government / Non-Profit
Form Name 
Protocol R Investigator��s Brochure WA Instructions for Use (Device) WA Consent Form R HIPAA Authorization Form R UW Confidentiality Agreement R FDA Form 1572 WA FDA Device Letter WA Full or Partial HIPAA Waiver R UW/WIRB Cover Sheet R Investigator's Medical Licenses R Investigators�� CV(s) R Sponsor Authorization to Pay WIRB R SRC Approval R IRB Application - WIRB R
APPENDIX F F4

Page 92
HSD (for WIRB studies) 
Initiated by: 
Industry Non-UW Investigator UW Investigator Non-UW Investigator Government
Sponsored (Funded) by: 
Industry Dept  Government / Non-Profit
Form Name 
Protocol R Consent Form R HIPAA Authorization Form R UW Confidentiality Agreement R UW/WIRB Cover Sheet R IRB Application - WIRB R
UW��IRB 
Initiated by: 
Industry Non-UW Investigator UW Investigator Non-UW Investigator Government
Sponsored (Funded) by: 
Industry Dept  Government / Non-Profit
Form Name 
Protocol R R R OE OE OE OE Investigator��s Brochure WA WA WA WA WA WA WA Instructions for Use (Device) WA WA WA WA WA WA WA Consent Form R R R R R R R HIPAA Authorization Form R R R R R R R UW Confidentiality Agreement R R R R R R R IRB Application - UW R R R R R R R Full or Partial HIPAA Waiver R R R R R R R
APPENDIX F F5

Page 93
CC��IRB 
Emailed to Sonja Stella, Sue Hammond, Jennifer Jones and Jennifer Yahne 4/27/09 for verification Verified Karen Hanson 5/5/09
Initiated by: 
Industry Non-UW Investigator UW Investigator  Non-UW Investigator Government
Sponsored (Funded) by: 
Industry Dept Government / Non-Profit
Form Name 
Protocol/Activity Plan and/or entire Grant Application
R R R OE OE OE OE
Investigator Brochure (if applicable), drug booklet or information sheet supplied by the drug company (sponsor)
WA WA WA WA WA WA WA Instructions for Use (Device) WA WA WA WA WA WA WA Consent Form R R R R R R R HIPAA Authorization Form (UW) R R R R R R R UW Confidentiality Agreement R R R R R R R FDA Form 1572 WA WA WA WA WA WA WA
FDA letter with the IND/IDE assignment number and PI confirmation letter or documentation of FDA approval from the sponsor
WA WA WA WA WA WA WA
HIPAA Authorization to Use, Create and Share Health Information for Research
R R R R R R R UW/CC-IRB Cover Sheet R R R R R R R Repository, Registry or Databank Supplement (Form) WA WA WA WA WA WA WA Protocol Synopsis WA WA WA WA WA WA WA SRC Approval R R R R R R R IRB Application - CC R R R R R R R Protocol Disposition Form (PDF) R R R R R R R Funding Source Document (FSD) R R R R R R R
APPENDIX F F6

Page 94
IBC (SCCA) 
Initiated by: 
Industry Non-UW Investigator UW Investigator Non-UW Investigator Government
Sponsored (Funded) by: 
Industry Dept  Government / Non-Profit
Form Name 
Protocol R R R R* R* R* R* Investigator��s Brochure R R R R R R R Consent Form R R R R R R R FDA Form 1572 R R R R R R R IBC Clinical Trial Review Submission Form R R R R R R R Investigators�� CV(s) R R R R R R R NIH Appendix M R R R R R R R †Correspondence from NIH/OBA/RAC R R R R R R R
* IBC requires a protocol/clinical protocol, etc regardless of the funding source for the study. No exceptions. † RAC Commentary from review of the protocol - and any additional RAC-Sponsor or -investigator correspondence. The UW IBC must receive the RAC's comments.
IBC (UW) 
Initiated by: 
Industry Non-UW Investigator UW Investigator Non-UW Investigator Government
Sponsored (Funded) by: 
Industry Dept  Government / Non-Profit
Form Name 
Protocol R R R R* R* R* R* Investigator��s Brochure R R R R R R R Consent Form R R R R R R R Research Project Hazard Assessment (RPHA) Form R R R R R R R Investigators�� CV(s) R R R R R R R NIH Appendix M R R R R R R R †Correspondence from NIH/OBA/RAC R R R R R R R
* IBC requires a protocol/clinical protocol, etc regardless of the funding source for the study. No exceptions. † RAC Commentary from review of the protocol - and any additional RAC-Sponsor or -investigator correspondence. The UW IBC must receive the RAC's comments.
APPENDIX F F7

Page 95
RSC (UW) 
Initiated by: 
Industry Non-UW Investigator UW Investigator Non-UW Investigator Government
Sponsored (Funded) by: 
Industry Dept Government / Non-Profit
Form Name 
Protocol R R R R* R* R* R* Consent Form R R R R R R R 1 of 3 (whichever applies) IRB Application R R R R R R R IRB Application – WIRB R NA NA NA NA NA NA IRB Application – CC R R R R R R R Radiation Safety Application R R R R R R R
*Protocol or Literature Review
RSC (SCCA) 
Initiated by: 
Industry Non-UW Investigator UW Investigator Non-UW Investigator Government
Sponsored (Funded) by:   
Industry Dept Government / Non-Profit
Form Name 
Protocol R R R OE OE OE OE Consent Form R R R R R R R 1 of 3 (whichever applies) IRB Application R R R R R R R IRB Application – WIRB R NA NA NA NA NA NA IRB Application – CC R R R R R R R Radiation Safety Application R R R R R R R
APPENDIX F F8

Page 96
I & ID 
Initiated by: 
Industry Non-UW Investigator UW Investigator Non-UW Investigator Government
Sponsored (Funded) by: 
Industry Dept Government / Non-Profit
Form Name 
Protocol R R R OE OE OE OE Consent Form R R R R R R R New Implant & Investigational Device Form (NIIDR) R R R R R R R Instructions for Use (Device) R R R R R R R FDA Device Letter R R R R R R R
SRC (CC) 
Initiated by: 
Industry Non-UW Investigator UW Investigator Non-UW Investigator Government
Sponsored (Funded) by: 
Industry Dept  Government / Non-Profit
Form Name 
Protocol R R R OE OE OE OE Investigator��s Brochure WA WA WA WA WA WA WA Instructions for Use (Device) WA WA WA WA WA WA WA Consent Form R R R R R R R Cancer Consortium Submission Checklist R R R R R R R
APPENDIX F F9

Page 97
ITHS 
Initiated by: 
Industry Non-UW Investigator UW Investigator Non-UW Investigator Government
Sponsored (Funded) by: 
Industry Dept  Government / Non-Profit
Form Name 
Protocol R R R R* R* R* R* Investigator��s Brochure WA WA WA WA WA WA WA Instructions for Use (Device) WA WA WA WA WA WA WA Consent Form R R R R R R R HIPAA Authorization Form R R R R R R R 1 of 3 (whichever applies) IRB Application R R R R R R R IRB Application – WIRB R NA NA NA NA NA NA IRB Application – CC R R R R R R R AAA Packet w/Pricing Pages R R R R R R R Draft Detailed Budget Tool R R R R R R R Radiation Safety Application WA† WA† WA† WA† WA† WA† WA† Research Project Hazard Assessment (RPHA) Form WA WA WA WA WA WA WA IBC Clinical Trial Review Submission Form WA WA WA WA WA WA WA ITHS CRC Utilization Forms R R R R R R R New Implant & Investigational Device Form (NIIDR) WA WA WA WA WA WA WA Billing Grid R R R R R R R Documentation of Human Subjects Training R R R R R R R
* ITHS require a protocol regardless of the funding source for the study. If a PI hasn��t already developed one, they will provide them with a template. For simple studies this may only require a minimal amount of information but everyone has to submit one. No exceptions. † Occasionally ITHS requires proof of RSC approval for certain studies or where it��s not clear that this has been provided and noted by the IRB.
APPENDIX F F10

Page 98
KEY 
R Required IR If requested OE If one exists or is a close approximation WA When Applicable O Optional NA Not Applicable 1 Industry Initiated & Industry Sponsored 2 UW Investigator Initiated & Industry Sponsored 3 UW Investigator Initiated & Government or Non-Profit Funded 4 UW Investigator Initiated & Department Funded 5 Non-UW Investigator Initiated & Industry Funded 6 Non-UW Investigator Initiated & Government Funded 7 Government Initiated & Government Sponsored
APPENDIX F F11

Page 99
University of Washington Clinical Trials Process Improvement Project Achieved Improvements - Appendix G Achieved Improvement  Issue Resolved/To be Resolved Stakeholder Responsible Next Steps 1 Executive sponsors own the process. R. Meisinger is the agent of the Executive Sponsors At the start of the project, no one knew who owned the process since it spanned organizational boundaries. Stakeholders wanted ownership defined. Executive Sponsors Complete 2 An online Clinical Research Handbook was conceptualized, designed, planned and is under development. Create an easily accessible place where current information about the Clinical Research Proposal process is available to stakeholders. RGE In progress. The first phase of the Handbook will be released in January 2010. 3 Flowcharts of the current/optimum process were developed. Processes were not documented. There was confusion about how parts of the process worked. Parts of the process were informal and varied. Personnel changes caused processes to "fall apart" because they were person dependent. Relationships between parts of the process were not well understood. RGE In progress. Include flowcharts in Clinical Research Handbook. 4 Key front-end questions to be answered by the PI/SC were defined. Decision trees to answer questions were developed. Definitions, examples & contacts for consultation will be included in the Clinical Research Handbook. Do I need a Radiation Safety review? Do I need an Institutional Biosafety review? Which IRB do I use? These were questions that could be difficult to answer. Failure to raise and answer the questions in the front- end of the process caused delays, restarts & rework downstream. Questions are answered by PI/SC. RGE provides information to aid in the decision-making via the Clinical Research Handbook. In progress. Include In Clinical Research Handbook.
APPENDIX G G1

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University of Washington Clinical Trials Process Improvement Project Achieved Improvements - Appendix G Achieved Improvement  Issue Resolved/To be Resolved Stakeholder Responsible Next Steps 5 Packages' of required documents/forms based upon answers to the front-end questions were developed. The answers to the front-end questions determined the materials that must be put together for the proposal package. Previously, people had used their own "cheat sheets" but there had been no common definition of what needed to be submitted and to whom. PI/SC completes the "packages." Units (e.g. HSD, OSP, CRBB, etc. update the package requirements) In progress. Include In Clinical Research Handbook 6 Master agreements have been posted on the OSP website and additional agreements will continue to be developed. Let PIs/SCs know which industry sponsors have master agreements. OSP Complete 7 Handoffs within the CRBB part of the process were decreased & multiple entries of the same information eliminated. Non-value added steps. CRBB Implement 8 For the SFI process, OSP added the eGC1# to SFI disclosure form An audit trail was needed in case the SFI disclosure form became separated from the OSP Complete. New form is posted online. SFI disclosure form disclosure form became separated from the eGC1. posted online. 9 Status points' for each part of the process that are currently collected in organizatonal unit data systems were identified. Status points have also been identified that are not currently collected in information systems but have been cited as being potentially useful status information for stakeholders. Some status points existed but points across the Clinical Trials Proposal process had not been identified. Status points must be indentified in order to develop an interim tracking system. RGE Complete. Organizational units can use identified status points to develop metrics for their units as a first step toward a cross- process tracking system.
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University of Washington Clinical Trials Process Improvement Project Achieved Improvements - Appendix G Achieved Improvement  Issue Resolved/To be Resolved Stakeholder Responsible Next Steps 10 Part of the 'to be hired' Clinical Research Administrator's job will be to further develop and maintain the Clinical Research Handbook. The Handbook must be continually updated in order to remain relevant. RGE In progress. Complete Clinical Research Administrator position description, get HR approval & hire. 11 The Clinical Research Administrator will provide staff support to the Steering Committee and will provide project management support for improvement projects initiated by the Committee. The Clinical Research Administrator takes over this function from the Project Consultant and Project Manager. RGE In progress. Complete Clinical Research Administrator position description, get HR approval & hire. 12 The UWMC & SCCA agreed to streamline separate Radiation Safety reviews into one process with a common form. Previously, the PI/SCs had to do one process for UWMC and another for SCCA, separate applications for each. Radiation Safety - UWMC & SCCA In progress. Implement pilot to test this approach. 13 UWMC & HMC agreed to streamline separate Implant & Investigational Device reviews into one process with a common form. Previously, the PI/SCs had to do one process for UWMC and another for HMC, separate applications for each. Compliance for UWMC & HMC In progress. Develop new form and implement new process. 14 Contacts (individuals) will be identified for When the PIs/SCs had questions, they did RGE In progress. Include contact 14 Contacts (individuals) will be identified for each part of the process to help stakeholders navigate the Clinical Research Proposal process. When the PIs/SCs had questions, they did not know who to call. RGE In progress. Include contact information in the Clinical Research Handbook. 15 HSD & Radiation Safety reached agreement to continue to transmit all IRB approval notices to Radiation Safety (manually). The question had been raised regarding whether all notices should be sent and whether they should be sent manually or electronically. HSD & Radiation Safety Complete. In the longer term, consider sending only those cover sheets with RS. Send cover sheets electronically. 16 CRBB is the responsible agent for identifying Medicare Secondary Payer (MSP) issues and communicating the issues to HSD, OSP and the PI & SC. Need to clarify roles and responsibilities related to MSP. CRBB In progress. CRBB develops process and communicates process to HSD, OSP and PIs/SCs.
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University of Washington Clinical Trials Process Improvement Project Achieved Improvements - Appendix G Achieved Improvement  Issue Resolved/To be Resolved Stakeholder Responsible Next Steps 17 OSP will not hold up contract signing in order to perform a review of the Consent Form. Need to clarify OSP's role related to the Consent Form. HSD In progress. Determine whether HSD wants OSP to conduct a post-contract review of the Consent Form to ensure that no subjects are enrolled until the Consent Form and contract are aligned. Per HSD, a final review is a regulatory requirement. 18 Common definitions for "adverse effect" and "complications" have been developed There is no common definition of these terms and this causes confusion among stakeholders. HSD In progress. If any inconsistencies remain, reconcile the definitions & publish in the Clinical Research Handbook. 19 CRBB is responsible for managing the exemption policy for the ORCA care plan. Need to clarify roles and responsibilities related to ORCA care plan. CRBB In progress. CRBB notifies IRB committees of the new exemption policy for the ORCA care plan. CRBB should communicate with HSD about exemptions. related to ORCA care plan. IRB committees of the new process and provides contact information. 20 Related to contract amendments & extensions, CRBB reviews residuals before OSP negotiates contract. CRBB reviews others on a case-by-case basis as determined by OSP. Need to clarify OSP & CRBB roles and responsibilities related to contract amendments & extensions. OSP/CRBB In progress. CRBB partners with OSP to develop process. CRBB initiates. 21 CRBB develops a standard template that identifies all UW representatives & roles and provides this to sponsors. Sponsors confused about UW contacts and roles and responsibilities. CRBB In progress. CRBB shares template with OSP. 22 CRBB does not perform "final review" after budget documents are signed and sent to PI/SC. Are these process steps value added? CRBB CRBB discontinues performing this function.
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University of Washington Clinical Trials Process Improvement Project Achieved Improvements - Appendix G Achieved Improvement  Issue Resolved/To be Resolved Stakeholder Responsible Next Steps 23 Agreement that SFI disclosure letter will continue to be sent manually since switching to electronic requires a change in UW & GIM10 policies. Currently, the letter is sent manually in a sealed envelope. With changes in confidentiality around SFI, explore whether the letter can be sent electronically with the eGC1 & disclosure form. SFI Complete 24 Developed internal risk management matrix for clinical trial agreements & reviewed risk management strategies with UW Risk Management Office. Provides OSP with more authority to negotiate contracts & speeds up the negotiation process. OSP Complete 25 Revised and streamlined clinical trial check processing. This eliminated steps for OSP & facilitates official accounting for a study. Clarify roles and responsibilities between OSP & GCA related to check processing. OSP Complete 26 Revised account authorizations/electronic funding actions for clinical trials. This allows a project to make expenditures for start-up needs before subjects are enrolled in a study. This eliminates a procedure called "advance budgets" and enables a project to establish and account even if the money has not been received from the sponsor. Accordingly, a OSP Complete needs before subjects are enrolled in a study. received from the sponsor. Accordingly, a study can run a deficit until the sponsor does transfer funds to the study account. The department is ultimately responsible if expenditures are made and an account is not funded. 27 Established process for SCs to obtain read- only SPAERC access. SCs have access to information about their proposal. OSP Complete
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University of Washington Clinical Trials Process Improvement Project Recommended Improvements - Appendix H Recommendation for Improvement Issue Resolved/To be Resolved Stakeholder Responsible Next Steps 1 Option 1: Radiation Safety does not wait for SRC approval before starting their review if the PI/SC anticipates Radiation Safety Review is required. Option 2: Radiation Safety starts review after receiving SRC approval. Waiting for SRC approval means the Radiation Safety review gets started later than it could. Radiation Safety In progress. Discuss options with Steering Committee. 2 Clarify which study proposals will be reviewed by the SRC. There is confusion regarding the studies that need to go to the SRC. SRC In progress. Ask Sonja for documented agreement. 3 Determine if it is appropriate to perform front-end triage at the departmental level to gauge if a study has sufficient merit to start through the proposal process. Are there studies that should not even start through the process? Note: Oncology is performing analysis on a retrospective of studies that will be helpful in exploring this topic. RGE Steering Committee establishes priority. Explore this at some point in the future after other process improvements have been implemented 4 To manage proposal workload, establish prioritization guidelines. Should some studies be higher priority than others? Currently, all studies are assumed equal in importance. RGE Steering Committee establishes priority. 5 Design, implement & staff a Clinical Research Front-end process activities greatly RGE In progress. Clinical Service Center that: 1) provides front-end 'triage' support to PI/SC so key questions are answered, packages assembled and sent to the right places at the right times; 2) provides status on proposals; and, 3) helps PIs/SCs navigate the complete process. influence the success and efficiency of downstream process activities. Currently, there is not a central place for PIs/SCs to go for support as they initiate and attempt to navigate the Clinical Trials Proposal process. Research Administrator will be FTE #1. Clinical Research Administrator will perform a subset of all activities planned for the Service Center.
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University of Washington Clinical Trials Process Improvement Project Recommended Improvements - Appendix H Recommendation for Improvement Issue Resolved/To be Resolved Stakeholder Responsible Next Steps 6 Provide orientation to the Clinical Research Handbook to help PIs/SCs navigate the process, including completing the forms and documents required in the "packages." Frequently, stakeholders report that forms/documents are missing from the proposal packages, information is missing on a form or document and/or forms/documents are improperly filled out. This causes rework loops as corrections are made. [OSP has surveyed stakeholders & found that PIs/SCs want orientation on how to initiate research.] RGE Start immediately. Plan orientation for stakeholders. 7 Encourage each organizational unit to identify, collect and report metrics desired by stakeholders Although multiple units are collecting some data that might be used to determine the status of a proposal, the data reside in multiple systems that were not built to provide status information. Currently, the capability to status a proposal across the whole process does not exist. Additionally, data do not exist to determine the time it takes a proposal to go through the whole Each organizational unit. Steering Committee establishes priority, facilitates continuing conversations and coordinates metrics work with the Research Roadmap project. process. 8 Establish universal reference # [perhaps the "registration number" that may be used for the interim tracking system]. A single proposal is referred to by many numbers - each unit has their own - this causes great confusion. RGE Steering Committee establishes priority. 9 Acquire a management information system to automate the Clinical Trials Proposal Process. This would be a web-based system that stores & tracks all study proposal documents. Information would be entered once and populated to the relevant documents. Out of scope - Research Roadmap Office of Research Out of scope.
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University of Washington Clinical Trials Process Improvement Project Recommended Improvements - Appendix H Recommendation for Improvement Issue Resolved/To be Resolved Stakeholder Responsible Next Steps 10 Option 1: HSD publishes a deadline rule (like OSP's GIM19) specifying the time required to process the proposal application for IRB approval. Option 2: HSD develops a process to work with the schools/departments so they are notified as soon as "intent to fund" is known. That way HSD can remind the PI to complete the IRB application as soon as possible. Option 3: HSD develops a process to work with Grants and Contract Accounting so they are notified when an advance budget is assigned to a proposal. That way HSD can remind the PI to complete the IRB application as soon as possible. Timely submission to IRB for government/foundation funded proposals. HSD In progress. HSD makes recommendation to Steering Committee. Option 1: HSD drafts policy, consults with constituents, then pilots draft policy with selected departments. At the end of pilot, HSD finalizes policy & communicates policy to stakeholders. Option 2: HSD develops process for getting "intent to fund" information from the schools/departments. (HSD - are additional resources required?). Option 3: HSD develops process for acquiring advanced notification of advance budget assignment. (HSD, are additional resources required?). 11 Create a central electronic location where stakeholders can find the most recent version of the Consent form. The consent form can change during the proposal process and stakeholders who review it do not necessarily know if they are looking at the most recent version. HSD In progress. HSD is working with ORIS to develop a central location for the Consent Form.
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University of Washington Clinical Trials Process Improvement Project Recommended Improvements - Appendix H Recommendation for Improvement Issue Resolved/To be Resolved Stakeholder Responsible Next Steps 12 HSD is the contact/clearing house for all suggested changes to the Consent Form. Role/responsibility related to the Consent Form unclear. HSD Start Immediately. HSD works with Radiation Safety, Institutional Biosafety, Investigational Drugs and the PIs/SCs to develop clearing house process. (HSD, are additional resources required?) . 13 HSD does not send proposal applications to WIRB until the Consent Form is completed. Elimination of rework. If Consent Form is modified, then application has to go back through WIRB process. HSD Start immediately. HSD drafts policy, consults with constituents then pilots draft policy with selected departments. At the end of pilot, HSD finalizes policy & communicates policy to stakeholders. (HSD, are additional resources required?) . 14 Resolve the following questions related to the Consent Form: 1) When IRB requests changes in the Consent Form, how best can these be communicated to CRBB so that the budget can be prepared accurately? 2) How can CRBB communicate early enough with HSD about potential incentive payments or subject reimbursements to avoid having the IRB review the Consent Form multiple times? 3) What is the best way to make sure that the Consent Form language is in alignment with the budget & contract? Keeping abreast of Consent Form changes. HSD/CRBB In progress. HSD & CRBB will meet to resolve these questions.
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University of Washington Clinical Trials Process Improvement Project Recommended Improvements - Appendix H Recommendation for Improvement Issue Resolved/To be Resolved Stakeholder Responsible Next Steps 15 Define the process for cooperative group and intergroup studies. Related to Radiation Safety & SRC. These may be cancer studies that do not go through SRC. From H. Vesselle mtg. 7/28/09. In progress. Consult with Sonja Stella. 16 For investigator initiated studies, develop standards for protocols to increase quality. Protocols can be difficult to decipher. Steering Committee establishes priority. Requires initiation of a project. 17 Provide required clinical information to hospital service centers so they can generate pricing pages. Service Centers report they do not have the required clinical information needed in order to perform the pricing function. RGE In progress. Diane Merz reports new process to Steering Committee & provides process information for Clinical Research Handbook. 18 Establish a central point of distribution for pricing sheet requests. For SCCA studies, PIs/SCs send pricing requests to the Research Implementation Office (RIO, S. Johnson & G. Roper) and they interface with the service centers. This works well and it's easier to tell when a RGE In progress. Diane Merz reports new process to Steering Committee & provides process information for Clinical particular service center might be experiencing problems in responding to requests. This is a suggestion to have the same type of process on the UWMC side. Research Handbook. 19 For UWMC, develop a price list that can be used for developing preliminary budgets. SCCA has developed a price list (not yet posted online) of the 100 most requested prices that can be used for preliminary pricing purposes. When the actual budget is developed, the regular pricing pages process must still be used. RGE In progress. CRBB to implement as part of Pricing Pages project.
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University of Washington Clinical Trials Process Improvement Project Recommended Improvements - Appendix H Recommendation for Improvement Issue Resolved/To be Resolved Stakeholder Responsible Next Steps 20 Establish master confidentiality agreements (CDAs) with industry sponsors that frequently fund studies. Establish a formal process for processing CDAs when an institutional signature is required. Track status of CDAs. More industry sponsors are requiring an institutional signature on the CDA. This is a suggestion to develop master CDAs (one per industry sponsor) with participating institutions (e.g. UW, FHCRC, etc.) signing the master CDA. OSP Steering Committee establishes priority. 21 Establish standard naming conventions (a glossary) for the documents being used throughout the Clinical Trials Proposal process. Referring to the same form/document using different names causes confusion. RGE Steering Committee establishes priority & determines where "glossary of record" resides. 22 Establish a name/number for each proposal so it can be referred to in the same way across the process Proposals are referred to by different names across the process which causes confusion. RGE Steering Committee establishes priority. 23 Expand "Industry Relations" coordinated effort. Example: Eli Lilly visit. OSP Ongoing 24 Have a joint preliminary review when IBC is required at both SCCA & UW then PI can answer all questions at once. Currently, the PI has to answer questions about the study twice, once for SCCA and once for UWMC. EH&S Steering Committee establishes priority. Determine if there are enough studies to make this worthwhile. 25 Develop Intellectual Property (IP) language/procedures that are relevant for industry studies. IP policy covers an extensive range that is not relevant when an investigator is using an industry sponsor's drug. In this case, there is no IP for the PI and the PI knows this. Sometimes, the proposal gets bogged down related to IP when it does not need to. In progress. Sonja will talk to Mac. He can help frame this for discussion with Tech Transfer and OSP. Dick will talk to OSP. 26 Invest in "Study Manager" tool for study administration. Out of scope but a really good idea! Out of scope. 27 Revise the CRBB website - make it more user friendly & intuitive Out of scope Out of scope.
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University of Washington Clinical Trials Process Improvement Project Recommended Improvements - Appendix H Recommendation for Improvement Issue Resolved/To be Resolved Stakeholder Responsible Next Steps 28 Determine possible impacts to the Clinical Trials Proposal process on the new Administrative Policy Statement (APS) on data security. Will researcher have new obligations? HSD In progress. Discuss with K. Moe. 29 Implement a bi-weekly telecon between OSP & CRBB to share negotiation strategy on proposal applications. How can CRBB & OSP communicate the status of each others' negotiations to help prioritize the workload? CRBB/OSP In progress. CRBB (K. Hilty) arranges a 3 month pilot. 30 For Significant Financial Interest process, streamline submission of disclosure letter along with electronic eGC! & SFI disclosure form. To submit electronically, requires a change in UW confidentiality rules & GIM10 policy. Current submission is manual and separate from the eGC1 and SFI disclosure form. SFI Steering Committee establishes priority. 31 Integrate non-industry sponsored clinical trials (federal, foundation, academic and other non-profit) and industry sponsored clinical trials into OSP's Clinical Trial Group. This organization change within OSP combines all of the office's clinical research expertise in one area (Michael, Karl & Brandon). For example, it might be necessary to negotiate with a third party OSP Implement new organization change. sponsor (e.g. an industry sponsor) on a government or foundation-sponsored grant. The industry sponsor may be supplying a drug or device as part of the study. Also, even on a government/foundation funded grant, there might be a contract with another site. Expertise for all of these contractual issues will be centered in one place within OSP. 32 Clarify subject injury billing and policies with other offices (HSD, CRBB, UW Medicine). Achieve consistent UW position so all UW offices are operating from the same script when dealing with outside agencies. OSP OSP convenes stakeholders to achieve, document and implement consistent process across offices.
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University of Washington Clinical Trials Process Improvement Project Recommended Improvements - Appendix H Recommendation for Improvement Issue Resolved/To be Resolved Stakeholder Responsible Next Steps 33 Clarify and resolve uncertainties regarding Medicare Secondary Payer issues with other offices (AGO, HSD, CRBB). Achieve consistent UW position so all UW offices are operating from the same script when dealing with outside agencies. OSP OSP convenes stakeholders to achieve, document and implement consistent process across offices. 34 Clarify and update UW Human Subjects Injury Compensation Program. Achieve consistent UW position so all UW offices are operating from the same script when dealing with outside agencies. Risk Management Convene stakeholders to achieve, document and implement consistent process across offices.
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University of Washington  Clinical Trials Process Improvement Project 
Appendix I  10/27/2009 
  Possible Responsibilities/Duties for Clinical Research  Service Center  Possible Responsibilities/Duties for Clinical Research  Administrator  (FTE#1)    Manage, maintain and continue to develop the Clinical  Research Handbook  Manage, maintain and continue to develop the Clinical  Research Handbook  Facilitate clinical research proposal process:  • Provide ��front end�� triage support  • Provide advice & information about the process to  stakeholders  • Assist stakeholders in process problem resolution  • Serve as liaison across the process (e.g. UW, SCCA,  FHCRC,CHMC)  Facilitate clinical research proposal process:  • Provide ��front end�� triage support  • Provide advice & information about the process to  stakeholders  • Assist stakeholders in process problem resolution  • Serve as liaison across the process (e.g. UW, SCCA,  FHCRC,CHMC)  Coordinate existing training related to Clinical Research  Proposal Process & identify new stakeholder training  needs  Coordinate existing training related to Clinical Research  Proposal Process & identify new stakeholder training  needs   Track & report status of study proposals  • Collect & report data, for example the time from  submittal of proposal to enrollment of subjects  (possibly use dashboards/scorecard)  • Refine process measures    Manage Clinical Research Data, e.g.   • How many studies  • $ amount  • How much is clinical  • Etc.    Staff Steering Committee & working groups  Staff Steering Committee  Provide project management for improvement projects  Provide project management for improvement projects  Provide pool of Research Coordinators     Support StudyManager software package    Support industry sponsor relations    Support subject recruitment    Support continuous improvement of the Clinical Research  Proposal Process   Support continuous improvement of the Clinical Research  Proposal Process  Maintain Clinical Trials Discussion Group Listserve    Review information from PIs & register studies on  clinicaltrials.gov (Move function from HSD)    Develop, implement & maintain a Clinical Trials website.    Create additional tools that customers can use to navigate  the process    Assist PIs & SCs in using tools such as the Clinical Research  Handbook to navigate the process    Create the systems (e.g. administrative) required for  efficient Service Center operation    Manage Service Center Staff     
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1
Design/Functionality
Clinical Trials Start-Up Handbook
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2
MethodNavigationProsConsBased on:
Idea #1 Idea #2 Idea #3
Design/Functionality Ideas: Clinical Trials Start-Up Handbook
❑Text Based ❑Table of Contents ❑Index ❑Search ❑Simple ❑Based on existing UW design ❑Multiple navigation methods ❑Requires navigating through text UW Medicine Guide to Electronic Grant Submission ❑Text Based, combined with leading question and answer ❑Table of Contents ❑Good method for new investigators ❑Limited navigability, requires step-by-step Emory University Protocol Routing and Approval Process ❑Graphics Based, combined with informative text ❑Graphical/Tree Structure table of Contents ❑Good high-level View of process ❑Limited search (keyword) capability Stanford/Packard Center for Translational Research in Medicine Process Maps: Stanford Clinical Research ❑Text Based ❑Table of Contents ❑Simple ❑Based on existing UW design ❑Requires navigating through text UW Medicine: Office of Clinical Research Clinical Trials Administrative Start- Up Handbook
Current
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Current
3
Screenshot
APPENDIX J J3

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Idea #1: Table of Contents View
4
Mock-Up Screenshot 1 of 3
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Idea #1: Index View
5
Mock-Up Screenshot 2 of 3
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Idea #1: Search View
6
Mock-Up Screenshot 3 of 3
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Idea #2: Initial User View
7
Mock-Up Screenshot 1 of 3
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Idea #2: User view after answering questions
8
Mock-Up Screenshot 2 of 3
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Idea #2: User view with information callouts shown
9
Mock-Up Screenshot 3 of 3
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Idea #3: User initial high-level view with some open files
10
Mock-Up Screenshot 1 of 3
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Idea #3: Initial User View of chosen item
11
Mock-Up Screenshot 2 of 3
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Idea #3: User view with information callouts shown
12
Mock-Up Screenshot 3 of 3
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13
Technology Overview
Clinical Trials Start-Up Handbook
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Technology: CMS Options Explored
14
Slide 1 of 3
What is a Content Management System?
A CMS is server software that manages content (text, images and data) separate from the designed page layout that you view in your browser. Because content is kept separate from design (usually in a database), it is relatively easy to develop and deploy new layouts, navigation and style elements. A CMS also: gives your website a more consistent look and feel makes it easier to meet accessibility standards gives your content writers and producers a tool to review and publish/unpublish content Content Management Systems Being Used at UW
Drupal Plone Sharepoint Wordpress Joomla Wiki (various)
Information from UW Creative Communications website
*
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Ranked #1 in Popularity (16 respondents) Ranked #1 in User Satisfaction •Evans School of Public Affairs •Facilities Services •Department of Biostatistics •Risk Management •Office of Research
Technology: CMS Options Explored
15
UW CMS User Survey*Sampling of UW UsersCommon Characteristics/Requirements
Slide 2 of 3
Tied for #2 in Popularity (11 respondents) Ranked #2 in User Satisfaction •Department of Radiology •Learning & Scholarly Technologies •Health Evidence Resource for Washington State Tied for #2 in Popularity (11 respondents) Ranked #3 in User Satisfaction •Foster School of Business •The Information School •Department of Psychiatry and Behavioral Sciences •Human Resources Information Systems
Drupal Plone SharePoint
Content Management Systems use at the UW by Oren Sreebny, Executive Director of Emerging Technology in UW Technology, Published January 26, 2009 54 respondents; Other systems in use: Wordpress, Joomla, Wiki, Movable Type, Ektron, Confluence, TextPattern, Alfresco, and several custom systems.
❑Easily integrate with other web sites and applications ❑Can accommodate UW��s existing netid service ❑Uses standard programming language(s) ❑Will integrate with UW existing technical infrastructure ❑Adheres to accepted programming standards and best practices ❑Has a robust user community (both at UW and Publicly) ❑Variety of third-party support (including training) available ❑Vendor and/or users are committed to ongoing technical and functional development and improvements ❑Thorough documentation available
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Open source modular framework and Content Management System (CMS) Free
r ats
GNU GPL (free) Any Yes Limited type ion d
s
Free Add On Yes ju st
type
Free Add On Yes Yes type in a
whole
Yes
Technology: CMS Options Explored
16
What is It?System Requirements ▪Approximate Cost (software only) ▪License ▪Operating System ❖Applications: ▪Discussion Forum ▪Document Management ▪Events Calendar ▪Hierarchical Content Browse ▪Link Management ▪Search engine ▪Syndicated Content (RSS) ▪User Contributions
Slide 3 of 3
Open source Content Management System (CMS) rats why won��t
this
Free
r ats
GNU GPL (free) Any Free Add On Yes
ttttttttgdggdsgfg
Yes Yesjust t
ype
Yes Yes Yes type on a
whole
Yes A collection of products and software elements
type in a whole bunch of n
Not Free
r ats
Commercial, per CPU Windows Yes Yes just type in a
wh
Yes Limited just type
w awjfj
Yes Yes Yes type in a
whole
Yes
Drupal Plone SharePoint
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Technology
❑Selection of Technology ❑Description of chosen Technology ❑Define Technology Owner(s) ❑Define Technology Oversight ▪define who will be responsible for quality control ▪define help-desk function ❑Upfront (start-up) cost ▪software ▪hardware ▪labor ❑Maintenance (ongoing) cost ▪software ▪hardware ▪labor ❑Implementation Timeline (includes design and content portions) ❑Data source detail ▪define how data will be obtained ▪define how data will be stored ▪define how data accuracy and integrity will be maintained
Handbook: Next Steps for Analysis
17
Design/Functionality
❑Selection of Design/Functionality ❑Description of chosen Design/Functionality ❑Fit-Gap analysis ▪Design/Functionality –vs- chosen technology ❑Estimate of time needed to complete design plan ❑Mock-up final design ❑Documentation of design standards for future additions
Content
❑Define Content of Phase Release ▪initial release ▪enhancements ▪ideal (limitless time/limitless budget) ❑Define Content Owner(s) ❑Define Content Oversight ❑Define Content maintenance standards ▪scheduling ▪versioning
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Project Plan
Clinical Trials  Handbook
APPENDIX K K1

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2
3 4 5 7 8 9 10 – 13 14 16 – 17 18 19 20 21 22 24 25 26 27 – 28 29 – 35 ❑Introduction ❑Implementation Timeline ❑Cost (startup and ongoing) ❑Description of Design/Functionality ❑Fit-Gap Analysis ❑Design Plan Timeline Estimate ❑Mock-up Final Design ❑Documentation of Design Standards for Future Revisions/Additions ❑Description of Technology ❑Technology Owner(s) ❑Technology Oversight ❑Upfront (start-up) Cost ❑Maintenance (ongoing) Cost ❑Technology Implementation Timeline Estimate ❑Content of Release Phases ❑Content Gather and Load Timeline Estimate ❑Content Owner(s) ❑Content Oversight ❑Appendix: Outline of Existing Handbook
Design/Functionality Technology Content
❑Project Plan: Table of Contents
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3
❑Introduction
A Brief History The Clinical Trials Administrative Start-Up Handbook was originally developed at the University of Washington School of Medicine in order to ensure that the administrative start-up process for industry- sponsored clinical trials could be accomplished as quickly and efficiently as possible. Over time, the Handbook evolved to present practical information not only about the start-up process of industry- sponsored clinical trials but also about other practical information relating to clinical research. This project plan outlines the strategy and details for the January 2010 release of the next major iteration of the Clinical Trials Handbook. The new handbook is one of the deliverables for the Clinical Research Proposal Review Process Improvement Project. The end result is meant to include the following items: Process documentation Checklists – What activities need to happen when Timeline standards Definition of roles/responsibilities Additionally, the existing handbook will be recast into the new handbook format, providing a solid base upon which to build this and future iterations of the Clinical Trials Handbook . Intended Audience The handbook is addressed to all researchers who conduct clinical trials at the UW and it��s affiliates. We hope that the handbook will be especially useful for new clinical trials researchers. Although experienced researchers may already have developed handbooks of their own, we hope that some parts of this handbook will also be helpful to them. Note that investigators conducting clinical trials on site at the Veterans Affairs Puget Sound Health Care System (VAPSHCS) may have different or additional requirements for the administrative start-up process.
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❑Implementation Timeline (estimate)
Design Plan Complete Handbook Framework Complete Aug 24 Sep 28 Start Jul 13 Go-Live Jan 4
6 wks 4 wks 8 wks 2 wks 4 wks
Begin Content Load Begin Framework Build Begin Design
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❑Cost (startup and ongoing)
DesignTechnical •Hardware •Software •Labor ❑Content Total Cost estimate
oResearch and Graduate
Education
oUW Technology oDrupal / open source content
management platform
oCreative Communications oORIS oResearch and Graduate
Education
oResearch and Graduate
Education
Service Provider Cost Startup Ongoing/ annually
No charge No charge No charge $10,000 No charge No charge No charge $10,000 No charge $600 No charge $1,000 No Charge No charge $1,600
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Project Plan
Clinical Trials Handbook
Design/Functionality
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❑Description of Design/Functionality
7
The design of the Clinical Trials Handbook is intended to present information to users in a clear, concise manner while still providing a depth of information for those who wish to utilize the handbook for more in-depth guidance. The information in the handbook will be delivered utilizing a combination of the following pages:
Searchable text  pages 
Some information (e.g. instructions, rules, regulations) is best delivered in the traditional written format. These pages will be key-word searchable. Pages 10 and 11 of the design section of this document are examples of this type of page.
Navigable process maps
A navigable process map presents the user with a logical flow diagram of a given process. Many of the graphical elements of this process map will be ��clickable��, meaning they will allow the user to access more information about whatever is contained in that element. This could be an informational box, a link to another website, a contact list, a form, and online document, or any other number of informative resources. Page 12 of the design section of this documents shows an example of this type of page.
Pages which incorporate inline frames
An inline frame will display another website, or document (including scrollbars and borders ) within the page without opening a separate window. Many of the areas which affect the clinical trials start-up process already have their own websites. Rather than trying to duplicate the information contained on those websites, this handbook will display them where applicable. Page 13 of the design section of this documents shows an example of this type of page.
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❑Discussion Forum ❑Document Management ❑Events Calendar ❑Hierarchical Content Browse ❑Inline Frames ❑Link Management ❑Navigable Image Maps ❑Search engine ❑Syndicated Content (RSS) ❑User Contributions
8
Yes Limited Free Add On Yes No Free Add On No Yes Yes Yes
Design/Functionality Drupal (basic template  provided by ORIS) ❑Fit-Gap Analysis: Design/Functionality – vs – Technology (Drupal) Solution
Not an issue because of small number of people who will be editing documents Minor additional resources to implement Will require additional resources to implement Minor additional resources to implement Will require additional resources to implement
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Menus
This is what the user will see across the top of the page and on the left side of the screen. Menus provide information to help navigate the content and links.
Navigation
This is what drives the menus. It is a roadmap that tells the programmer what to display on the menus.
Page Hierarchy
This is what drives the navigation. It is the bulk of the work that will go on behind the scenes prior to loading any content. It requires deciding how things should be organized and how the site should be structured.
Graphic Elements/Icons
Any icons, pictures, illustrations, special diagrams, etc. will need to be created in advance for inclusion on the website. This time estimate includes design and creation of image files.
Process Maps 
Creation of process maps for web display and printer friendly versions Total Time to produce a complete design plan for use by a web programmer to build the framework for the handbook site, does not include content load.
9
Design/Functional Element ❑Design Plan Timeline Estimate Time: Plan and  Document
1 week 1 week 4 weeks 2 weeks 2 weeks 10 weeks
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❑Final Design/Mock-Up
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11
❑Final Design/Mock-Up
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❑Final Design/Mock-Up : Navigable Process Map
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❑Final Design/Mock-Up : Inline Frame
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❑Documentation of Design Standards for Future Revisions/Additions
Documentation of design standards will be completed as a part of the execution of this project plan. Design standards will be the result of a combination of several sources: UW Updated Graphics and Logo System documentation, a standards compliant theme developed by ORIS, an RGE specific design guide for the handbook. The purpose of a design standards document is to ensure a distinct, consistent, and well-managed visual identity for the handbook. This identity is intended to represent the handbook as a unique product with its own content and purpose, but still clearly indicate that the handbook is a product of the University of Washington, intended to serve the UW Medicine community and it��s affiliates. Documentation of design standards is intended to address the following aspects of the handbook: ❑logos ❑color palettes ❑typography (font sizes and styles) ❑iconography ❑visual cohesiveness ❑page layouts ❑menu structure ❑navigation ❑user experience ❑readability ❑ease of use
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Project Plan
Clinical Trials Handbook
Technology
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16
A CMS is server software that manages content (text, images and data) separate from the designed page layout that you view in your browser. Because content is kept separate from design (usually in a database), it is relatively easy to develop and deploy new layouts, navigation and style elements. A CMS also: gives your website a more consistent look and feel makes it easier to meet accessibility standards gives your content writers and producers a tool to review and publish/unpublish content
Drupal Plone Sharepoint Wordpress Joomla Wiki (various)
Information from UW Creative Communications website
* ❑Description of Technology What is a Content Management System (CMS)?  Content Management System in Use at UW 
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Drupal: What is It?
Content Management Systems use at the UW by Oren Sreebny, Executive Director of Emerging Technology in UW Technology, Published January 26, 2009 54 respondents; Other systems in use: Wordpress, Joomla, Wiki, Movable Type, Ektron, Confluence, TextPattern, Alfresco, and several custom systems.
❑Easily integrate with other web sites and applications ❑Can accommodate UW��s existing netid service ❑Uses standard programming language(s) ❑Will integrate with UW existing technical infrastructure ❑Adheres to accepted programming standards and best practices ❑Has a robust user community (both at UW and Publicly) ❑Variety of third-party support (including training) available ❑Vendor and/or users are committed to ongoing technical and functional development and improvements ❑Thorough documentation available
Open source modular framework and Content Management System (CMS) Ranked #1 in Popularity (16 respondents) Ranked #1 in User Satisfaction ❑Evans School of Public Affairs ❑Facilities Services ❑Department of Biostatistics ❑Risk Management ❑Office of Research ❑Discussion Forum ❑Document Management ❑Events Calendar ❑FAQ Management ❑Hierarchical Content Browse ❑Link Management ❑Search engine ❑Site Map ❑Syndicated Content (RSS) ❑User Contributions ❑Wiki
❑Description of Technology (continued) UW CMS User Survey* Sampling of UW Users Characteristics/Requirements Applications (highlights)
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❑Technology Owner(s)
18
Ownership of the Clinical Trials Handbook technology should be divided into two categories, Hardware and Software.
Hardware (Infrastructure) Ownership 
The Clinical Trials Handbook will be hosted on UW Technology servers. There is currently no charge for the use of UW Technology server space; however, this is expected to change and will be discussed later in the costing portions of this plan. UW Technology will be responsible for any maintenance and updates associated with the servers which house the handbook. Consequently, handbook usage will be constrained by the common maintenance schedule (and associated downtimes), or unexpected technical issues which affect the UW Technology servers. Additionally, handbook usage will be bound by the same development, testing, and security protocols in use at UW Technology.
Software Ownership
Although Drupal is an open source (free) product, whoever installs and maintains it is considered the ��owner�� of the software. In the case of the handbook, ORIS (Office of Research Information Services) will be the owner. ORIS will be responsible for any ongoing maintenance, upgrades, and patches and fixes associated with Drupal. The handbook will be expected to adhere to the same development, coding, design and testing standards used by other applications owned by ORIS. There is currently no charge proposed for ongoing services provided by ORIS; however, this could change if future versions of the handbook require programming or maintenance services above and beyond basic levels. This will be discussed further in the costing portions of this plan. Additionally, ORIS will not be providing any programming for the initial setup of the handbook.
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HardwareSoftwareContent
19
Quality control for the servers which house the handbook will adhere to the UW Technology support approach. UW Technology works to assure that the University��s current and future technology needs are being met, and strives to utilize the best of current and emerging technologies. ORIS will assure quality control for the Drupal installation by applying patches and fixes as necessary and analyzing new software version releases for desired functionality. The Office of Research and Graduate Education will be responsible for assuring that the content of the handbook is accurate and that where changes are made to supporting websites or documentation that those changes are reflected in the handbook.
Quality Control Help Desk Function
ORIS utilizes a bug tracking mechanism called FogBugz. An email is sent to a centralized mailbox and analyzed to determine the nature of the problem. Technical issues are routed to the appropriate technical help-desk. •Hardware issues are routed to UW Technology •Software issues are routed to ORIS •Content related issues will be routed to the Office of Research and Graduate Education . In addition to the email routing from FogBugz, RGE will seek to provide phone support for help-desk issues. Technical issues will be routed to the appropriate technical area. Content related issues will be handled internally, or where appropriate referred to a different functional area.
❑Technology Oversight
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HardwareSoftwareLabor •Hardware (setup) •Software (setup) •Design •Programming •Graphic Design •Content Load •Miscellaneous Total Cost estimate for Handbook Start-Up
20
UW Technology Drupal / open source content management platform UW Technology Creative Communications – Environment Create ORIS - Template Research and Graduate Education Creative Communications Creative Communications Research and Graduate Education Creative Communications Research and Graduate Education Creative Communications 15% Contingency
Service Provider Cost
Currently No charge for departmental account on UW Technology servers.
No charge for software or licensing No charge $1,000 No charge No charge $1,000 $4,500 No charge $1,000 No charge $1,000 $1,500 $10,000
❑Upfront (start-up) Cost
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HardwareSoftwareLabor •Programming •Content Load Total Cost estimate for ongoing handbook maintenance and customization (if applicable)
21
UW Technology Drupal / open source content management platform Creative Communications ORIS Research and Graduate Education
Service Provider Cost/per year
Currently no charge for departmental account on UW Technology servers; however, this is expected to change at any time. Unknown what the charges will be, estimate using private hosting cost estimate:
$600 No charge for software or licensing
No charge for routine work from ORIS, handbook specific customization (estimate is for work performed by either service provider):
$1,000 No charge $1,600
❑Maintenance (ongoing) Cost
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Hardware Setup Handbook owner (RGE) will submit a request to UW Technology for the setup of a departmental server account. ❑Drupal Environment Creation Creative Communications will install and secure Drupal and its supporting database and create user accounts for staff access to the administrative pages. ❑Drupal Template Load Creative Communications will install templates provided by ORIS. ❑Drupal Template Customization Creative Communications will make changes to ORIS supplied templates to reflect changes approved during the design process. Some changes may be required for iframes and large image display. ❑Designer Acceptance Testing RGE will review and test completed handbook framework to assure that all design requirements have been accommodated and to submit additional requirements that had not previously been anticipated. This time includes programming for those changes. Total Time to have a Drupal framework available to begin loading content
22
Technology Phase ❑Technology Implementation Timeline Estimate Time
3 days 1 week 2 days 4 weeks 1 week 7 weeks
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23
Project Plan
Clinical Trials Handbook
Content
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24
❑Content of Release Phases
Phase I
Existing Handbook Content ▪Information which is currently contained in the Clinical Trails Administrative Start-Up Handbook that pertains to the start-up phase of the proposal review process will be converted to fit the new handbook format. ▪Information which is outdated or inaccurate, or has been replaced by information in the new content section of this plan will not be converted. •New Content ▪Information which has been gathered in the course of the Clinical Research Proposal Review Process Improvement Project will be formatted to fit the new handbook and included where appropriate.
Future Phases (TBD)
Existing Handbook Content ▪Information which is currently contained in the Clinical Trails Administrative Start-Up Handbook that was not included in Phase I, but which is still accurate and pertinent to any phase of clinical trials will be converted to fit the new handbook format. •New Content ▪Any new information which is gathered as a result of ongoing process improvement, user input, committee recommendations, or other initiatives will be considered for inclusion in future releases.
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Conversion of Existing Handbook Content Some information currently contained in the Handbook will be converted to fit the new handbook format (see Appendix A: Outline of Existing Handbook). ❑Gather/Create New Content Results of previous meetings, research and documentation will be presented in a cohesive, consistent format and integrated (where appropriate) with existing content (from existing handbook). ❑Verify All Phase I Content All Phase I content will be reviewed for accuracy, consistency, and completeness ❑Load All Content All Phase I content will be loaded into the new Drupal handbook framework. ❑Internal Review of Handbook Beta Version  ❑RGE project staff will review the completed beta version prior to user acceptance testing and make any necessary changes. ❑User Acceptance of Handbook Beta Version  User acceptance testing by pre-determined user group, make any necessary changes prior to go-live Total Time to convert, gather, create, load and test content
25
Content Steps ❑Content Gather and Load Timeline Estimate Time
2 weeks 4 weeks 2 weeks 2 weeks 2 weeks 2 weeks 14 weeks
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❑Content Owner(s)
26
For the purpose of the ownership discussion, the content contained in the Clinical Trials Handbook can be divided into two categories, Primary Content and Secondary Content.
Primary Content Ownership  •Primary Content is the content which is directly loaded and/or entered by the editor of the
handbook. As owner of the primary content the Office of Research and Graduate Education will be responsible for assuring that the content of the handbook is accurate and complete.
•Examples of Primary content include: process maps; glossary information; policy and procedure
information written specifically for inclusion in the handbook (regardless of the subject of those policies and procedures); instructional, or informational text written specifically for inclusion in the handbook; links included with any text written specifically for inclusion in the handbook.
Secondary Content Ownership •Secondary content is the content which is accessed by either linking or by entry or uploads from
staff outside of the Office of Research and Graduate Education. For example, Human Subject Division will be responsible for the content of their own website and any information, links, forms, documents, etc. contained on that website.
•The Office of Research and Graduate Education will be responsible for content to the extent of
assuring that where changes are made to supporting websites or documentation those changes are reflected in the handbook. E.g. links are kept current, referenced forms are current, contact information is current.
•In some cases, staff from areas outside of the Office of Research and Graduate Education may be
given access to directly update select sections of the handbook. Those areas will be responsible for assuring that the information they contribute is accurate and kept up to date.
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❑Content Oversight
27
Oversight for the content of the Clinical Trials Handbook will be the responsibility of the Clinical Trials Process Improvement Project steering committee. The steering committee will be supported by the Office of Research and Graduate Education. The editor of the handbook will be Office of Research and Graduate Education staff. Content oversight responsibilities will be divided as follows between the editor and the steering committee.
Ongoing maintenance and quality assurance
The editor will be responsible for assuring that information is accurate, up to date, and reflects mandated requirements. Any changes necessary to fulfill this mission will be at the discretion of the editor and will not require pre-approval from the committee. A high-level summary of this type of activity will be provided to the committee during regularly scheduled meetings.
Minor content and/or functionality changes/additions 
In response to user feedback, suggestions, industry trends, etc. the editor may make minor additions to the content and/or functionality of the handbook without prior approval from the committee. Examples of this level of activity include:

new content sections associated with existing content.

new links associated with existing content.

new display techniques which enhance the user experience but do not change the overall look and feel of the site.

new graphics which enhance the user experience but do not change the overall look and feel of the site. The committee will be provided with a detailed listing of all changes for post-review.
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❑Content Oversight (continued)
28
Major content and/or functionality changes/additions
The editor will submit to the committee for approval any new content sections or new functionality which provide information or functionality not previously contained in the handbook. Which change the overall look and feel of the site, and which greatly change the user experience. The editor will also respond to requests for any level of change (maintenance, minor or major) from the steering committee. These changes may be in response to user feedback, suggestions, industry trends, technology innovations, etc . Examples of major content and/or functionality changes/additions fitting this criteria include:

Addition of new process maps not previously included

Addition of new information about a process, committee, service center, facility, etc. not previously included.

Addition of a training component.

New method of site navigation which may either replace the current navigation or provide an additional navigation method such that the user experience will change greatly.

Change to the color scheme, icons, graphics that greatly alter the look of the site.

Removal of large sections of existing content.
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❑Appendix: Outline of Existing Handbook
29
Preface ❑Purpose of the Handbook ❑Intended Audience ❑How To Use the Handbook ❑Other Help 1. Getting Started ❑Flow Chart ❑Confidentiality Agreements ❑Is your trial feasible? ❑Clinical Research Training ❑Using Medical Records ❑Financial Planning ❑Indirect Costs ❑The Clinical Research Budget and Billing office (CRBB)
oWhy CRBB was created oHow CRBB is organized oBest Practices for working with CRBB
•When working with CRBB •When building your budget •When negotiating your budget •When sending your eGC-1 packet for review
oRequesting a Budget Number oThe AAA Trial Registration System oKey Contacts
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❑Appendix: Outline of Existing Handbook
30
oTimeline
❑Enrollment/Recruitment Incentives ❑Credentialing ❑Hazardous Substance Training and Certification ❑Registering and Publicizing Your Study
2. Research Service Centers
❑General Information ❑Investigational Drug Service (IDS) at UWMC ❑Investigational Drug Service (IDS) at HMC ❑Radiology Research Services (RRS) - UWMC and South Lake Union
oAbout RRS at UWMC oBest Practices for Using the UWMC Radiology Research Services oKey Contacts oTimeline
❑Radiology Research Services (RRS) at HMC
oAbout RRS at HMC oBest Practices for Using the RRS at HMC oKey Contacts oTimeline
❑Laboratory Services
oDepartment of Laboratory Medicine
•Research Testing Services (RTS) •AAA Research Testing Services
oBest Practices for using Laboratory Medicine
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❑Appendix: Outline of Existing Handbook (continued)
31
oLaboratory Medicine testing services key contacts oLaboratory Medicine Research Testing Service Timelines oNorthwest Lipid Research Laboratories (NWRL)
❑Cardiology Diagnostic Services
oAbout Cardiology Diagnostic Service oBest Practices for Using Cardiology Diagnostic Services oKey UWMC Contacts oKey HMC Contacts oTimeline
3. Office of Sponsored Programs (contracts, financial disclosure, and the eGC-1 process)
❑Flow Chart Illustrating the Office of Sponsored Programs Process ❑The Research Agreement ❑The Concurrent Review Process
oWhat it is oHow it works
•At CRBB •At OSP ❑Best Practices
oFor Using the Concurrent Review Process oFor Streamlining the OSP Review Process oFor Completing the eGC-1 Form for Industry-Sponsored Clinical Trials
❑Significant Financial Interest Disclosure ❑The Budget Number ❑Advance Budget Numbers
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❑Appendix: Outline of Existing Handbook (continued)
32
❑Key OSP Contacts ❑Timeline
4. UW Institutional Review Boards
❑Flow Chart - UW IRB ❑Flow Chart - Western Institutional Review Board (WIRB) ❑Flow Chart - UW-WIRB Process ❑Flow Chart - Cancer Consortium IRB ❑General Information about Institutional Review Board (IRB) Review ❑Determining Where Your Trial Needs to be Reviewed
oIf Your Trial is Reviewed by the UW IRB oIf Your Trial is Reviewed by Western Institutional Review Board (WIRB) oIf Your Trial is Reviewed by the Cancer Consortium IRB (CC-IRB)
5. Radiation Safety Committee
❑Flow Chart Illustrating the Radiation Safety Committee Process ❑Quick Access to Forms Referenced in this Section ❑Review Requirements ❑Radiation and Pregnancy ❑RSC Application Forms for New Studies ❑Best Practices for Completing the Application Forms
oConsent Form Radiation Risk Statements oForm 32 (for annual renewals)
❑Administrative Start-up Checklist ❑Key Contact
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❑Appendix: Outline of Existing Handbook (continued)
33
❑Timeline 6. Institute for Translational Health Sciences ❑Flow Chart Illustrating the Clinical Research Center Process ❑General Information ❑Best Practices for Developing the CRCN Budget ❑Best Practices for Completing the ITHS Application ❑Best Practices for Using the ITHS Facilities ❑Key Contacts ❑Timeline 7. Human Gene Transfer Review ❑The National and Local Review Process ❑Best Practices for Expediting the Committee Review ❑Administrative Start-Up Checklist ❑Key Contact ❑Timeline 8. Biosafety Review ❑The Review Process ❑Best Practices for Expediting the Biosafety Committee Review ❑Administrative Start-Up Checklist ❑Key Contact ❑Timeline
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❑Appendix: Outline of Existing Handbook (continued)
34
9. Implant & Investigational Device Committee ❑Flow Chart Illustrating the Implant and Investigational Device Review Process ❑General Information
oCategory A Devices oCategory B Devices
❑Review at UWMC and HMC
oUWMC New Implant and Investigational Device Form oHMC New Implant and Investigational Device Request Form
❑Best Practices for Expediting the Review ❑Key Contacts ❑Timeline 10. Preparing for FDA Inspections ❑Why are FDA inspections done? ❑What is the regulatory basis of FDA inspections? ❑Does the FDA publish advice about its own inspections? ❑What types of inspections does the FDA conduct? ❑How does the FDA notify clinical investigators about impending inspections? ❑How long do FDA inspections last? ❑How do I prepare for an FDA inspection? ❑What happens after the inspection? ❑General advice for study staff 11. Investigator Responsibilities ❑General Information
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❑Appendix: Outline of Existing Handbook (continued)
35
❑Investigator Responsibilities - A Brief Outline ❑Useful Web Resources ❑Useful Self-Assessment Checklists ❑Responsibilities of the Sponsor-Investigator 12. Useful Tools and Checklists ❑Completing Case Report Forms - Rules of Thumb ❑Concomitant Medication Log ❑Data and Safety Monitoring Board Charter ❑Drug Inventory and Accountability Log ❑Feasibility Checklist ❑Study Coordinator Time Tracking Log ❑Study Site Signature and Delegation of Responsibility Form ❑Subject Enrollment Log ❑Telephone Communication Record ❑Virtual Regulatory Binder - Partners HealthCare, Boston Staff Task Lists ❑Pre-study tasks ❑On-study tasks ❑Post-study tasks Other Resources ❑Clinical Research Toolbox (NIH/National Institute on Aging)
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Tell Me What You Need?
Where is it?When did it get there?What is the expected turnaround?Who has it?When will they begin working on it? When did they finish with it? What is happening to it?If they have questions or issues will they contact me?If they are done with it and/or it results in an approval, will they let me know right away, or  do I have to wait for some other process to be completed (e.g. copies mailed)?How much time will it take to notify me of any decisions or changes that are made?Can I be notified of important milestone/approvals that happen while it is there that may  allow me to proceed with other steps, even if it hasn��t been finalized? What are the delays between stopsWhere is it when it is stalled?Why is it stalled?
Clinical Research Proposal Review Process Improvement Project: Tracking System Workgroup 1
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Where are we now?
PIRO/DORA:PIRO: (Protocol Institutional Review Office )database used by  Institutional Review Office and the Protocol Office at Fred Hutchinson  Cancer Research CenterDORA: (Database of Research Activity )used by the Human Subjects Division and the Office of  Sponsored Programs at University of Washington Both systems share a common framework, but contain different data SAGE/ SPAERC/Status TrackerSPAERC: (Sponsored Programs Administration Electronic Research) used by the Office of  Sponsored Programs at University of Washington The ��backend�� system used in OSP which holds the data used in SAGESAGE: (System to Administer Grants Electronically) used by thousands of users across the  University of Washington eGC1 is the submittal form used by SAGE which routes electronicallyStatus Tracker: used  by departmental administrators to check the status of their contractsPulls data from SPAERC
Clinical Research Proposal Review Process Improvement Project: Tracking System Workgroup 2
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Challenges
Functional ChallengesMuch of the data that will be useful for tracking purposes is  dependent on manual inputMust be adopted by all contributors of data, otherwise the data won��t be completeWill need to develop some form of common tracking number for referenceCannot require duplicate (or more) entry into multiple systems, making the new system more  labor intensive and/or slower than current systems is a guarantee of failure Technical ChallengesIs questionable if current source systems have the ��technical backbone�� to support this  endeavorNeeds to stay in sync with the source systems, nightly updates may not be frequent enoughIt is not clear how existing systems will talk to each other.May be difficult to ��normalize�� the data �� relate information from different system that share  a common proposal
Clinical Research Proposal Review Process Improvement Project: Tracking System Workgroup 3
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Where could we go? 
MS Sharepoint:HR at UW has made use of Sharepoint for trackingSharepoint has a pre��built add��in for tracking and also one for workflowSupports web service calls and can be pushed to a portalNetid supported for user authentication Integrates easily with other MicroSoft products Campus EAI (new campus portal project)Campus EAI is a new portal product developed by a consortium of mid��size Colleges and  Universitiesa user��centered application that provides users with their own personalized, customized, and  adaptive collection of Web pagesa web front��end to display data necessary for tracking the progress of a proposal
Clinical Research Proposal Review Process Improvement Project: Tracking System Workgroup 4
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Clinical Research Proposal Review Process Improvement Project: Tracking System Workgroup
Conceptual System Structure
CURRENT SOURCE SYSTEMS CONSOLIDATION OF SOURCE DATA
SPAERC /  SAGE DORA / PIRO CRBB  data files Radiation  Safety  data files BioSafety data files I & I  Device  data files Others
USER INTERFACE
Data Warehouse
INFORMATION ABOUT THE PROPOSAL SharePoint Portal
5
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Keys for Success
Functional RequirementsSystem must be well planned in advance with plenty of input from experienced usersUser interface is intuitive and does not require more than basic web skillsUsers need to know that the system exists and that it is a reliable source of informationRoll��out must be done in a timely mannerSystem ownership and ongoing support needs to be determinedSystem development and support must be given high priority  Technical RequirementsSource systems and tracking system must support a core of common fieldsShould be just as reliable as the source systems, in both data and technology aspectsNeeds to have role��based accessShould support web servicesMust be accessible via the web and not require any individual desktop install)
Clinical Research Proposal Review Process Improvement Project: Tracking System Workgroup 6
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Appendix M  University of Washington  Clinical Research Proposal Process Improvement Project  Interim Tracking System – Options to Consider  What we know at this point:  • To track across the whole Clinical Research Proposal process requires that status points be extracted from multiple systems.   • The effort to extract and report status points from multiple systems is complex.  • The cost to build an Interim Tracking System may be significant.    OPTION 1  OPTION 2  OPTION 3  • Move ahead with pricing the project to  build the Interim Tracking System. This  will require identifying the resources to  accomplish this task since the CTPIP  project manager is focused on building the  Clinical Research Handbook.  • Determine how to fund the project to  build the Interim Tracking System. For  example, the units involved in the process  could decide to share the cost.    • Encourage units (OSP, Radiation Safety,  Institutional Biosafety, SCCA, etc.) to  gather and publish their particular unit��s  status information. Some units already do,  e.g. HSD.  • Wait for a cross process solution from the  Research Roadmap.  • Wait for a cross process solution from the  Research Roadmap.  Pros:  • Provides status information to customers.  • Builds a baseline of data across the whole  process that can be used to validate  problem areas.  Cons:  • Costs to build the system may be  significant.  Pros:  • Status information for additional  individual units becomes available.  • No cost to build a system across the whole  process in the interim.  Cons:  • No way to status across the whole process  • No baseline data across the process.  • May require effort on the part of some  units to collect status information  internally  Pros:  • No cost to build a system across the whole  process in the interim.  • No effort required by units who are not  already reporting.  Cons:  • No way to status across the whole  process.  • No baseline data across the process.  • Status information is not available for  individual units that do not currently  collect status information internally.   
Appendix M          10/29/2009 
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Appendix N University of Washington Clinical Trials Proposal Process Improvement Project Interim Tracking System - Key Status Points Enter Process Mid Points Exit Process System Data Element CRBB PI/SC submits matls. To CRBB [CB2.1] Summary Review distributed to stakeholders [CB2.40] Access database RS Submit completed form and Human Subjects Radiation Approval Committee (HSRAC) [R1.6] Scientific Executor (SE) and HSRAC Chair sign approval document(s) [R1.25] UW-IBC Submit RPHA to RBSO [B1.4, B2.1, B2.15] (1) Submit for public RAC review [B3.3]; (2) Receive approval from public RAC [B3.4] Notify PI, IRB of approval & changes to Consent Form [B2.11] SCCA-IBC (1) Submit proposal to NIH/OBA [SB2.0]; (2) Submit IBC Clinical Trial Review Submission Form and IBC application to RiO [SB1.9] (1) Submit for public RAC review [SB2.3]; (2) Receive approval from public RAC [SB2.4] Notify PI of approval via IBC approval letter [SB1.17] I&ID Receive IDE intake form/Medicare packets (if applicable)/NIIDR (if applicable) [D1.9] Compliance submits Medicare packets to Noridian [D1.19] (1) PI notified that device is authorized [D1.17]; (2) Receive approval letter from Noridian [D1.21] SFI OSP receives SFI documents from PI [SF1.10] RGE transmits memo to OR with supporting documents [SF1.21] OR notifies stakeholders of SFI management plan & marks approval in SPAERC [1.25] SPAERC? HSD/UW-IRB Initial intake by HSD front desk staff [H1.2] Administrator asigns to primary reviewer & assigns review date [H1.7] (1) Approved, send approval documents to PI [H1.19]; (2) Disapproved, send letter to PI [H1.21]; (3) Deferral or conditional approval, send letter to PI [H1.22] DORA HSD/WIRB Initial intake by HSD front desk staff [W1.6] Scan coversheet, consent form, HIPAA form DORA
Appendix N 1 10/29/2009
& send to PI [W1.7] HSD/CC-IRB Initial intake by HSD front desk staff [C1.2] Scan coversheet, send to PI & Protocol Office [C1.6] DORA Protocol Office Protocol Office receives documents [PO1.4] N/A FYI IRO/CC-IRB Initial IRO intake [CC1.2] (1) Expedited, IRB staff stamps approval documents & ships back to PI [CC1.10]; (2) Approved, documents released [CC1.32]; (3) Modifications required, send leter to Protocol Office [CC1.18] PIRO SRC SRC receives documents [SR1.1] SRC generates approval documents [SR1.8] OSP - Industry Sponsored OSP receives eGC1 [S1.1] OSP issues Electronic Funding Action [S1.22] SPAERC OSP - Govt./ Foundation Sponsored OSP receives eGC1 [S2.1] (1) Administrator submits documents to Sponsor [S2.5]; (2) OSP receives award notice [S2.11] OSP issues Electronic Funding Action [S2.27] SPAERC
Appendix N 1 10/29/2009
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University of Washington Clinical Trials Process Improvement Project End of Project Communications Planned
The Walker Company 1 Appendix O
Who is the Stakeholder When & What to Communicate Who Does the Communication Executive Sponsors ▪ Meeting scheduled for 10/16/09 ▪ Dick, Laura, Ann Steering Committee ▪ Meeting scheduled for 10/14/09 ▪ Dick Principal Investigators ▪ Draft article for OSP, HSD & CRBB newsletters that summarizes results and links to full end of project report ▪ Have ��grand opening�� for handbook after go-live in Jan. 2010 ▪ Laura & Dick MSEC (clinical chairs) ▪ Present full end of project report in Oct. or Nov. ▪ Dick & J. Slattery Hospital Leadership ▪ Present full end of project report in Oct. or Nov. ▪ Dick, Laura, Ann Health Sciences Associate Deans mtg. ▪ Present abridged end of project report in Oct. or Nov. ▪ Dick & J. Slattery CTBB Oversight Committee ▪ Present abridged end of project report in Nov. ▪ Dick Clinical Departmental Administrators ▪ Present full end of project report in Nov. ▪ Dick, Laura, Ann Attorney General��s Office (2 lawyers) ▪ Send end of project report. Discuss if requested ▪ Dick MDRN (UW & Harborview) • Present full end of project report in Nov. ▪ Dick ITHS • Present full end of project report at bi-weekly mtg. that John has that includes Nora D. ▪ J. Slattery Research Advisory Board • Present abridged end of project report ▪ Dick, D. Flores, J. Slattery Dean Ramsey, B. Ferguson, R. Mahan, M.F. Joseph • Will be covered in other mtgs. ▪
APPENDIX O O1

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