Approval Process

PRIT (Protocol Review and Initiation Team)

The PRIT consists of representatives from each of the cores that the protocol has requested resources from. Principal Investigators and their coordinators are invited to be present at the PRIT meeting to address concerns about the protocol such as Data Collection, Patient Safety, HIPAA and IRB issues, Nurisng Issues, Scheduling, etc. The PRIT essentially meets to facilitate Investigators to prepare their protocol for an easy and expedited passage through the GAC.

GAC (General Advisory Committee)

The General Advisory Committee (GAC) has the responsibility of reviewing, approving, and overseeing all research projects requesting GCRC support. The chairman of the GAC is Peter Glass, M.D. The committee meets monthly to evaluate proposals based upon scientific merit and need for center resources. Approved research projects are prioritized using these two factors. The committee is responsible for the designation of the category of inpatient days and outpatient visits for each research project.

The GCRC Co-Chair assigns a primary and secondary reviewer to each protocol submitted. The reviewer critiques the study in a written report which is presented at the monthly meeting, on the qualifications of the principal investigator, proposed science, suitability of study design, patient safety and need for center resources.

If the Committee approves the protocol with no changes, the investigator can begin to use GCRC resources immediately (assuming IRB approval has been granted). If the study is not approved as submitted, the protocol will be returned to the investigator with specific suggestions for revision. Approval following resubmission is usually expedited.

After each meeting, the principal investigator is sent written notification of the action taken by the committee.