Investigator Information

Reporting Requirements For Approved GCRC Protocols

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1. Initial
   Principal Investigators who have projects approved by the GAC are required to deliver the following IRB documentation to the Research Subject Advocate in the GCRC (either by e-mail, Rachel Posner at rachel.posner@mountsinai.org, or to the GCRC office 1184 5th Ave, Room 283):
   GCO. Page 1
   Protocol Summary
   Complete copy of the Protocol
   Assurance Page Administrative approved copy of the Informed Consent, stamped by the IRB;
2. Annual
   Upon annual review by the IRB and after IRB approval, the RSA requires the following documents to be delivered on an annual basis:
   GCO. page 1
   Updated Protocol Summary
   Updated Assurance Page
   Administrative approved copy of the Informed Consent, stamped by the IRB
   Annual Adverse Event Form
   Annual Enrollment Form;
3. Changes During Approval Period
   During the IRB approval period, should changes be made and submitted, a copy is to be forwarded to the RSA's office;
4. Adverse Event Reporting
   Following IRB Policy and procedure for AE or SAE reporting, the RSA's office requires copies of any AE reports. Alerting the RSA of Adverse Events, expected or not expected and in the event of Serious Adverse Events is required by the NIH.