Project Registration/Single Identifier

As communicated recently to School and Departmental leadership across campus, plans are underway to implement a new process in clinical trials during the study start-up phase. The Single Identifier initiative is a concept that began as a way for people engaged in clinical trial administration to have one identifier for a trial across the various offices (IRB, OSP, CBR, etc.) that review and track trials. While each office will still generate and apply a unique identifier for the trial, they will also capture the Single Identifier for reference purposes. After much discussion, it was determined that the IRB number would be designated as the Single Identifier for clinical trials. This was the preface for CBR to begin requesting the inclusion of the IRB number on submissions to their office last year for those who may recall.

Recognizing that less than 50% of trials are submitted to the IRB first and that the number would be needed to submit to other administrative offices, a way to generate that number is needed even if one is not ready to submit to the IRB, a process has been created to generate the number in IRAP. This is known within IRAP as Project Registration. The plan is to train personnel who may need to register their trials in IRAP prior to IRB submission to obtain a number so it may be shared with the various administrative offices during study start-up. The most likely people impacted are administrators, regulatory staff, and study coordinators who are engaged in start-up activities in addition to some investigators who may conduct these activities themselves.

If you have additional questions in the meantime, feel free to reach out to Mark Marchant in the Clinical Trials Administrative Office at 205-934-2098.