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How do I report amendments, suspensions and terminations?

Whenever a protocol is amended, it must be sent to the IRB for review. Once the amendment (and in some cases, the revised Informed Consent form ) has been approved, your NHLBI Program Official (PO) should be notified by sending the updated protocol with amendments clearly outlined, the updated consent form and the IRB approval letter.

In the event that your study is suspended or terminated by the IRB, by a DSMB or for other reasons, your Program Official(PO) must be notified in writing. Please include enough detail as to the reason(s) for suspension or termination and any recommendations made by the IRB or DSMB.

For trials conducting drug, device, or gene therapy research, the FDA must also be notified of any changes to the protocol, suspensions or terminations.

Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

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