Investigators are encouraged to use biostatistics consulting in advance of the review. Two reviewers from the Committee are assigned to each new clinical protocol. Copies are distributed to all committee members. The primary reviewer presents a critique of the protocol to the Committee at the scheduled CPRC meeting. The secondary reviewer provides supplementary comments.
Sufficient material is included to justify the proposed protocol.
The primary and secondary objectives are clearly stated and reasonably achievable by the study. Identify overlap with active approved protocols. When overlap exists, an appropriate prioritization plan is to be identified. Following discussion, the Committee votes to Approve, Approve with Stipulations, Defer or Disapprove the protocol. Approved Approved for opening to accrual contingent upon obtaining IRB approval and completion of all other protocol activation steps.