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Continuing Protocol Review
Just as the COMIRB requires a yearly continuing review so too does the
Pediatric CTRC. For all protocols supported by the CTRC the investigator
must submit to the CTRC administrative office a COMIRB continuing review
approval, current COMIRB-approved consent/assent forms and any new version
of the protocol. The RSA tracks continuing review dates and will expect
these documents upon continuing review approval. No additional documents
or review forms are needed. If any questions arise about a continuing
review, the RSA will contact the investigator personally.
For protocols which are classified as receiving significant assistance under
the Research Compliance Assistance Program (RCAP) the RSA will meet with the
investigator briefly at the time of each continuing COMIRB renewal. For protocols
monitored by the Cooperative Pediatric Data and Safety Monitoring Board, the
RSA and investigator will decide upon protocol review intervals a priori.
The RSA may be reached
at 303-764-8538.
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