Scientific Review Committee (SRC) Processes Pilot Study
During fall 2014, in follow-up to an initiative of the CTSA Steering Committee, a CTSA Consortium Scientific Review Committee (SRC) Consensus Working Group was formed. This group of experts and research stakeholders from nine CTSAs and NIH was charged with making recommendations for the scientific review process of human participant research prior to review by institutional IRBs. The goal was to create SRC processes that enhanced the scientific quality of clinical research, while minimizing delays and impediments to the research process. In February 2015, the Working Group generated recommendations for the SRC process at institutions and a plan to pilot the implementation of SRC processes.
The Working Group seeks to engage 12 CTSAs as participants in the implementation of the SRC process.
This project hypothesizes the implementation of the recommended SRC program will have a positive effect on the scientific quality and feasibility of clinical studies without degrading the efficiency of the overall human subjects protocol review process.
The pilot study will use a pre/post design with prospective data collected during baseline and intervention periods. Analyses will assess the implementation process (including satisfaction and burden) as well as short-range outcomes (including blinded assessment of changes in protocol quality, indicators of improved protocol feasibility, and evaluation of changes in time required to receive approval).
- Invitation Release: September 28, 2015
- Invitation Submission: October 9, 2015
- Notification of Participating Sites: October 19, 2015
- Invitation to Participate (PDF)
- Appendix A: Consensus Report on the Scientific Review Committee Process (PDF)
- Appendix B: Study Approach (PDF)
- CTSA Consortium SRC Pilot Study Scientific Quality Reviewer Guidelines (PDF)
Liza Patchen, Project Manager