Clinical Review Committee Full Proposal Review

The Investigator submits a full research protocol with a detailed research budget, including cost per patient and cost per intervention, a schedule of study procedures, and CVs for all investigators and Sub-Investigators to the Clinical Research Committee. It will be VERY HELPFUL for you to review the Clinical Review Committee review criteria before writing your protocol since any deficiencies will necessitate comment and revision.

• Clinical Study Review Criteria
• Pre-Clinical Study Review Criteria

The Clinical Research Committee reviews the full proposal and recommends approval, conditional approval or rejection.  The Clinical Review Committee Chair makes all final decisions regarding study approval. This information is communicated back to the Investigator through direct contact from the Clinical Research Committee within two weeks of the review.

Once the requested changes to the protocol, the Investigator resubmits the newly revised full research protocol to the Clinical Research Committee. Prior to resubmission to the Committee, the Investigator should carefully review the protocol and budget to make sure that the requested corrections have been incorporated, and that the protocol is complete.
 
The Committee Chair will approve the revised protocol after all issues have been satisfactorily resolved by the investigator. 

Next Step: Study Initiation

Back to: Submission Process Flowchart