Making Amendments to a Protocol That's Underway
Once your protocol is approved by COMIRB and the Pediatric CTRC it must
be conducted in accordance with the approved version of the protocol.
To do otherwise is a protocol violation which could have significant regulatory
consequences for the investigator. The protocol may not be changed without
seeking and obtaining approval to do so from both the COMIRB and the
CTRC. It is very common to begin running a protocol and discover that minor
changes are needed. The RSA is a good resource to discuss possible changes
and can advise you about how best to proceed.
Click here for the Protocol
Change Request form (Word doc).
Click here for the Protocol Change Request form (PDF version).
The RSA may be reached at 303-764-8538.
