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Protocol Timelines Tracking - Current

Tracking Protocol Development Timelines Steve Friedman, MHSA Chief, Clinical Trials Operations and Informatics Branch. Protocol Timelines Tracking - Current. CTEP’s PIO has been tracking and reporting protocol activity via: Bi-monthly reports to Cooperative Groups Queries to PIO

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Protocol Timelines Tracking - Current

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  1. Tracking Protocol Development TimelinesSteve Friedman, MHSAChief, 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. CTEP Secure Website – Search/Results Clicking on Select Protocols brings up a popup which allows the user to choose multiple protocols for the chosen organization only

  6. Sample Protocol Timeline – Unsolicited Phase 1 or 2 Study with a CTEP IND LOI Timeline (60 days) Protocol Timeline (150 days) 15 days 52 days 158 days 62 days LOI Approval F/U Consensus Evaluation and LOI Approval (30 days) Day 1 Day 30 Day 60 Initial LOI Consensus Evaluation (30 days) LOI Received Consensus Review sent to PI LOI Approval 04/01/2010 04/16/2010 07/16/2010 15 days 39 days 52 days Protocol Development Day 60 Protocol Development (60 days) Day 120 LOI Approval Protocol Receipt 07/16/2010 09/30/2010 76 days Protocol Approval Protocol Approval and Activation (25 days) Follow-Up Consensus Evaluation (35 days) Initial Protocol Consensus Evaluation (30 days) Day 120 Day 150 Day 185 Day 210 Consensus Review Sent to PI Protocol Receipt Protocol Approval on-hold Protocol Activation 09/30/2010 30 days 10/30/2010 46 days (Revisions = 2) 12/15/2010 6 days 62 days 02/21/2011 Planned Time Actual Time (ahead of schedule) Actual Time (behind schedule) Timeouts Gantt Chart

  7. Timelines Comparison – Gantt View

  8. 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).

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