Scientific Review Process at UNC
Beginning September 19, 2016 any new study submitted for IRB review will be required to have scientific review completed and documented.
All clinical research conducted at the University of North Carolina at Chapel Hill involving greater than minimal risk must undergo scientific review. Scientific review is a process that evaluates the scientific merit of a clinical trial protocol. The review must be completed and approved by the Scientific Review Committee (SRC) or Oncology Protocol Review Committee prior to IRB submission. If you are unsure if your project requires SRC review, please contact the IRB at 919-966-3113 or the Office of Clinical Trials at 919-843-2698.
For non-oncology studies, scientific review can be conducted externally by an independent organization that has no conflict of interest with the submitted research activity or internally by the UNC Scientific Review Committee. For example a multicenter study funded by the NIH or a multicenter industry-sponsored study with an external IRB is considered to have undergone scientific review. A UNC-faculty investigator-initiated study whether funded by the NIH or industry must undergo scientific review.
To submit your study for Scientific Review, please complete the SRC Review Request form found here. Send the completed form along with your full protocol (not grant proposal) to OCT@unc.edu.
For further assistance in developing your protocol, including biostatistics, please contact NCTraCS.
Links and guidance documents to help in developing a research protocol:
The links below provide information that may be useful to you in developing a protocol for submission to OCT for SRS review:
- CTTI Recommendations: Quality by Design
- CTTI Principles of a Quality Protocol Document
- CTTI Recommendations: Efficient and Effective Clinical Trial Recruitment Planning
- Learn about the CTTI Quality by Design project at www.ctti-clinicaltrials.org
- Presentation: Scientific Review Process Town Hall Meeting, September 27, 2016
Below are several templates for developing protocols. The most complete is the “Clinical Trials Protocol Template” for which there are two links — an educational one, including examples, and the shell, which is prepared for adding study-specific text as directed by the educational guidance.
- Clinical Trials Protocol Template – draft guidance from NIH & FDA
- Clinical Trials Protocol Template – shell
Here are alternative templates which are not as complete, but targeted to particular types of study.