GCRC Protocol Pre-Review Committees

Pediatric Protocol Review Committee (PPRC)
GAC Pre-Review Committee

The focus of these two Committees is on proper attention to human subject safety issues, compliance with federal regulations for patient consent, experimental design and statistical evaluation, and the appropriate use of GCRC resources. The Pediatric Protocol Review Committee (PPRC) reviews all pediatric research protocols. The PPRC is chaired by Thomas Carpenter, M.D., who is also a GCRC Research Subject Advocate (RSA) and Alia Bazzy-Assad, M.D. The General Clinical Research Center Advisory Committee (GAC) Pre-Review Committee, for adult protocols, is chaired by Rosa Hendler, M.D., GCRC Research Subject Advocate.

Prior to the formal protocol review by the full GAC Committee, new protocols are reviewed by these groups which include a primary scientific reviewer, the RSAs, a member of the administrative staff of the HIC, the GCRC biostatistician, a faculty member from the Informatics Core, the GCRC research nurse coordinator, and the Core Laboratory manager. The PI joins the Pre-Review Committee groups for an informal meeting to review all pertinent aspects of the study (including human protection issues, study design, biostatistics, resources utilization, etc). Importantly, issues are dealt with proactively and the majority of protocol revisions are completed prior to GAC review, thereby streamlining the review and approval process for the investigator, the GCRC staff, the GAC committee and the HIC. These meetings reduce the time of HIC and GAC approval, maximize patient safety and regulatory oversight, and provide an educational experience for investigators.

Following submission of the GCRC application to Sonja Beamon, a meeting will be scheduled with one of the Committees. (Note: If you are a pediatric investigator, please see PPRC schedule below before submitting your application to the GCRC.) The meeting schedule can be found under the appropriate target population below.

PPRC Schedule for pediatric protocols
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GAC Pre-Review Schedule for adult protocols
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