1. Tracking Protocol Development Timelines Steve Friedman, MHSA Chief, Clinical Trials Operations and Informatics Branch

2. Protocol Timelines Tracking - Current CTEP’s PIO has been tracking and reporting protocol activity via: –Bi-monthly reports to Cooperative Groups –Queries to PIO –Protocol Complete Sheets (NCI internal use) Majority of milestones already captured by CTEP Enterprise System (remainder are being added) Need for enhanced tracking mechanisms precipitated by OEWG recommendations

3. Protocol Timelines Tracking - Future As of Q3 2010, sites can access secure web site to retrieve timelines tracking reports Between Q3 2010 and Q1 2011, CTEP will solicit feedback on reports and modify Reports will be finalized prior to the start of the live period of OEWG recommended timelines Benefit of new tools include: –Dynamic update to information –Multiple views –Role based access

4. CTEP Secure Website – Access/Login Click here to access the secure website Users with IAM accounts with the following roles on protocols will be able to access and view their protocols Principal Investigator Site Coordinator Investigator Mail to Contact Primary CDUS Contact Secondary CDUS Contact Grant Investigator Grant PI

5. Clicking on Select Protocols brings up a popup which allows the user to choose multiple protocols for the chosen organization only CTEP Secure Website – Search/Results

6. Protocol Receipt Consensus Review Sent to PI Consensus Review Sent to PI Protocol Activation Protocol Activation Sample Protocol Timeline – Unsolicited Phase 1 or 2 Study with a CTEP IND LOI Received Consensus Review sent to PI Consensus Review sent to PI LOI Approval Protocol Development Protocol Approval Protocol Receipt Protocol Development (60 days) Initial Protocol Consensus Evaluation (30 days) Protocol Approval on-hold Protocol Approval on-hold 39 days 76 days 30 days46 days (Revisions = 2) Planned TimeActual Time (ahead of schedule) Initial LOI Consensus Evaluation (30 days) F/U Consensus Evaluation and LOI Approval (30 days) 04/01/201004/16/201007/16/2010 Day 1Day 30Day 60 LOI Approval Day 60 Day 120 Day 150 07/16/201009/30/2010 Day 185Day 210 Follow-Up Consensus Evaluation (35 days) Protocol Approval and Activation (25 days) 09/30/201010/30/201012/15/201002/21/20116 days Actual Time (behind schedule) 15 days LOI Timeline (60 days) Protocol Timeline (150 days) 158 days 52 days 62 days Timeouts 52 days 62 days Gantt Chart

7. Timelines Comparison – Gantt View

9. Protocol Tracker

10. Protocol Timelines – Detailed Gantt Sequential Chart

11. Protocol Timelines – Detailed Gantt Sequential Chart

12. Protocol Timelines Tracking - Interim CTEP will develop set of spreadsheets that will contain key information: –PI name –Org name –Protocol # –Completed milestones/stages –Duration of each completed milestone/stage Spreadsheets will be disseminated monthly until secure site is ready Post-meeting update: The Timelines Report website can now be found via the “Secure Access” tab in the upper right hand corner of the CTEP website (http://ctep.cancer.gov).