Protocol Maintenance

A. Renewal
NIH mandates that the GCRC Advisory Committee renews all protocols on an annual basis. Investigators are required to complete the PCRC renewal at the same time the IRB progress report is submitted. Please provide the PCRC administrative office with two copies of your IRB annual report together with the complete the PCRC renewal form.

Renewal Submission should include:

• Protocol revisions approved since prior review
• Completed PCRC renewal form
• Funding update
• Brief progress report

One member of the GCRC Advisory Committee will review the renewal submission and the committee will vote to the renew project. New priority scores may be assigned if the study has undergone major modifications. If the protocol is not renewed with the PCRC annually the protocol will be declared inactive and patients can not be admitted to the PCRC or clinic.

B. Terminations
Written notice of protocol termination must be submitted to the PCRC administrative office.