A.
Renewal
NIH mandates that the GCRC Advisory Committee
renew all protocols on an annual basis. Investigators are required
to complete the GCRC renewal at the same time the IRB progress report
is submitted. Please provide the GCRC administrative office with
two copies of your IRB annual report and the complete GCRC renewal
form.
Renewal submission should include:
- Protocol revisions approved since prior
review
- Completed GCRC renewal form
- Funding update
- Brief progress report
One member of the GCRC Advisory Committee
will review the renewal submission for presentation to the full
committee. The committee will vote to accept or reject the renewal
submission. New priority scores may be assigned if the study has
undergone major modifications.
If the protocol is not renewed with the GCRC
annually, the protocol will be declared inactive and will be withdrawn
from the unit. Patients will not be admitted to GCRC until the protocol
is renewed. There will be no exceptions!
B.
Terminations
Written notice of protocol termination must
be submitted to the GCRC administrative office.
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