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Medical School Required Use of the CTRF in eRPM
The Clinical Trial Routing Form (CTRF) allows study agreement contract negotiations to proceed in parallel with budget negotiations and regulatory approval.
We have had success in the use of the CTRF. In the Pilot, we had the option of sending draft industry-sponsored clinical trial contract agreements to ORSP to begin language review and negotiations prior to receiving the PAF. However, we also recognized in the Pilot, “noise” was created by last minute agreements that arrived at ORSP with the PAF, disrupting work flow. In an effort to continue streamlining the clinical trial process, more appropriately queue work, and capture performance metrics, the Medical School and ORSP are mandating the use of the CTRF for certain projects.
Effective 7/1/2013, the Clinical Trial Routing Form (CTRF) will be REQUIRED for all activity in 31200, Clinical Trial Site Activity. This expands the use from solely industry to any sponsor (federal, non-profit, AND industry).
Additionally, the CTRF should also continue to be used for investigator-initiated industry-sponsored clinical trials (in the Research class codes) when there is a draft agreement prior to a PAF routing.
We anticipate there may be some instances when you file a CTRF and then immediately route a PAF. We are aware and would like to observe the impact of these instances through data collection and direct feedback. We will be analyzing the relative benefit of the CTRF, its impact on both the time to execute study agreements and overall timeline to activate clinical trials.
We will be monitoring utilization of the CTRF and following up with further education for those units that do not use the form. We are interested in receiving feedback on any issues or potential barriers units identify.
If a project team has questions on the use the CTRF for their 31200 Clinical Trial Site Activity project, please call Heather Offhaus in the Grant Review & Analysis Office to discuss (734-763-4272).
See Using the Clinical Trial Routing Form (CTRF) for specific information on how to use them.