Running Your Protocol
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. The RSA may be reached at 303-764-8538.
It is also very common for ethical questions or concerns to occur to investigators
after a protocol is underway. The RSA is a biomedical ethicist and specializes
in research in pediatrics.
Knowing when and how to report an event as an Adverse Event (AE) or Serious
Adverse Event (SAE) is not always easy to determine. The protocol DSMP specifies
reporting requirements. One of the RSA’s particular areas of focus
is assisting investigators with the procedural and regulatory aspects of
reportable events. In addition, in the case of SAEs the RSA can be paged
at the time of the event for real-time assistance and guidance (303-890-8987)
