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ECOG ITrack Initiative Integrated Trial Development Process

ECOG ITrack Initiative Integrated Trial Development Process. March 23, 2010 Donna Marinucci. OEWG Vision. Based on OEWG’s Ultimate Vision: Coordinated, collaborative, interactive processes for timely development, review, revision and approval of all NCI-supported clinical trials.

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ECOG ITrack Initiative Integrated Trial Development Process

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  1. ECOG ITrack InitiativeIntegrated Trial Development Process March 23, 2010 Donna Marinucci

  2. OEWG Vision Based on OEWG’s Ultimate Vision: Coordinated, collaborative, interactive processes for timely development, review, revision and approval of all NCI-supported clinical trials. -- OEWG Clinical Trials Advisory Committee Report (11-4-09)

  3. Considerations for Process Improvement • Trial development steps performed in parallel • Project management/protocol tracking tools • Establish comprehensive, reliable system for reporting timeline performance for each step in trial activation • Assessment of staffing needs, job responsibilities, or reassignment • Collect timeline performance data

  4. ECOG Challenges • Multiple components from concept to protocol activation • Increased complexity of protocol development • No (real-time) central communication tool to share information among a wide variety of stakeholders • How to utilize current systems and track individual components; but w/o having to enter data in multiple locations • No document management system • Cost and rapidity of implementation

  5. ITrack Project • Requirements Planning • Integrated Protocol Tracking System • Reinforces Importance of Parallel Tracks • Systematically Developed Timelines • Highlights Impact of Delays • Variance Reporting ; Actual vs Projected timelines

  6. ITrack Document Management • In Addition to Tracking Timelines • Provides Centralized Document Storage • Version Control • Archiving • Discussion Thread • Reporting • Audit Trail

  7. ITrack System Specifications • Project Tracking System • Microsoft Project • Uses Windows SharePoint Services • 20 users license $2850.00 • Document Management System • Knowledge Tree • 20 users license $1957.65 • MySQL for the database, Apache for the web server • Custom Coding/Integration - 240 development hours

  8. System and Process • Access by authorized ECOG staff • Ability to limit a user’s access only to content that the user has been authorized to view. • Document storage, change tracking, audit trail and audit reporting • Track and assign user tasks and alert users of tasks • Send email notification of changes, issues and or alerts • Discussion area for questions comments concerning the project , task or issues

  9. Major Project Areas • Protocol Development • Laboratory Correlatives • Industry Support • Legal & Contracting • Forms Development • Regulatory Issues

  10. ITrack Project Server Home Page

  11. Each approved concept is entered on the project plan with standardized timeframes and resources.

  12. Case Report Forms • Worksheet to Statistician • Forms Team • All Internal Reviews • NCI Reviews through NCI’s • CDE Approval of CRF Packet • Input from Industry, If Needed

  13. Industry/Contracts • Industry Checklists • Kick-off Meeting with Industry • Industry Budget Review/Approval • Negotiation of Industry Agreement • Additional Agreements, If Required

  14. ITrack Documentation • Agreements with Industry • Budgets for Industry • Concepts • Correspondence • Forms • Industry Checklists • Protocols • Timelines

  15. Regulatory Regulatory • Documentation Received by Regulatory Officer • IND Application Submitted to FDA • FDA Reviews through • Approval of IND Application • Letter of Cross-Reference from Industry, As Needed

  16. ITrack Reporting • Ability to Run Queries • Actual vs Projected Dates • Analyze Trends • Barriers to Activation • Systematic Identification of at Risk Protocols

  17. ITrack Documentation • Organized by Protocol • Accessibility Within ECOG • Documents Version Controlled • Permanent Record of Documentation • Reporting Capabilities • Resource for Future Studies

  18. Upon user log-in, the Home Page (dashboard) displays any/all of the following: • Items that require attention • Alert/notification emails for these items are sent to designated external email addresses • Checked-out Documents • Go To Document ID • Recently Added/Changed Documents

  19. Each concept /protocol has a folder for storage and communication of all relevant information. Only authorized users can view information in the protocol folder.

  20. Concept/protocol folders contain the above folder structure for supporting documentation. Only authorized users can view information in the protocol subfolders.

  21. Information pertaining to document details and all changes are captured and displayed

  22. Discussion threads surrounding the protocol can be created and replies posted. Discussion threads can be closed when the discussion has come to a conclusion.

  23. An audit trail is available at the folder and document levels via the transaction history

  24. Questions and Discussions • Questions, Comments, Suggestions • Next Steps

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