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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 consent form) has been approved, your NHLBI Program
Director 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
Director 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.
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