1. eastern cooperative oncology group ECOG ITrack Initiative Integrated Trial Development Process March 23, 2010 Donna Marinucci March 23, 2010 Donna Marinucci

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

3. eastern cooperative oncology group 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. eastern cooperative oncology group 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. eastern cooperative oncology group  Integrated Protocol Tracking System  Reinforces Importance of Parallel Tracks  Systematically Developed Timelines  Highlights Impact of Delays  Variance Reporting ; Actual vs Projected timelines ITrack Project ITrack Project Requirements Planning

6. eastern cooperative oncology group  In Addition to Tracking Timelines  Provides Centralized Document Storage  Version Control  Archiving  Discussion Thread  Reporting  Audit Trail ITrack Document Management

7. eastern cooperative oncology group ITrack System Specifications 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. eastern cooperative oncology group  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 System and Process

9. eastern cooperative oncology group  Protocol Development  Laboratory Correlatives  Industry Support  Legal & Contracting  Forms Development  Regulatory Issues Major Project Areas

10. eastern cooperative oncology group ITrack Project Server Home Page

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

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

14. eastern cooperative oncology group ♦ Industry Checklists ♦ Kick-off Meeting with Industry ♦ Industry Budget Review/Approval ♦ Negotiation of Industry Agreement ♦ Additional Agreements, If Required Industry/Contracts

15. eastern cooperative oncology group  Agreements with Industry  Budgets for Industry  Concepts  Correspondence  Forms  Industry Checklists  Protocols  Timelines ITrack Documentation

16. eastern cooperative oncology group 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 Regulatory

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

20. eastern cooperative oncology group  Organized by Protocol  Accessibility Within ECOG  Documents Version Controlled  Permanent Record of Documentation  Reporting Capabilities  Resource for Future Studies ITrack Documentation

21. eastern cooperative oncology group 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

22. eastern cooperative oncology group Each concept /protocol has a folder for storage and communication of all relevant information. Only authorized users can view information in the protocol folder.

23. eastern cooperative oncology group Concept/protocol folders contain the above folder structure for supporting documentation. Only authorized users can view information in the protocol subfolders.

24. eastern cooperative oncology group Information pertaining to document details and all changes are captured and displayed

25. eastern cooperative oncology group Discussion threads surrounding the protocol can be created and replies posted. Discussion threads can be closed when the discussion has come to a conclusion.

26. eastern cooperative oncology group An audit trail is available at the folder and document levels via the transaction history

27. eastern cooperative oncology group Questions and Discussions  Questions, Comments, Suggestions  Next Steps  Questions, Comments, Suggestions  Next Steps