The Protocol Review Committee (PRC) is an independent body appointed by the National Heart, Lung, and Blood Institute (NHLBI). The PRC performs the first step in the review process for BMT CTN protocols, evaluating the protocol for its scientific merit. The PRC may either recommend approval of the protocol to NHLBI, or request that changes and/or clarifications are made.
The PRC assesses the scientific merit of each protocol using the following criteria:
- Importance of the question to be addressed
- Need for a multi-center network to meet objectives
- The merit of the experimental design, including appropriate controls
- Availability of adequate resources
- Adequacy and safety of study participant population and number of study participants,
- including appropriate representation of minorities, women, and children (if applicable)
- Appropriate recruitment strategies
- Adequacy of proposed plans for data acquisition, transfer, management, and analysis
- Adequacy of quality control of data collection and monitoring and overall coordination of protocol management
- Appropriateness of the plans to train center personnel to accomplish proposed research goals
The PRC includes a Chairperson and members whose experience reflects areas of expertise necessary to evaluate the scientific merit and design of BMT CTN protocols. Members may be added on an ad hoc basis to the Committee if expertise in a specific scientific area is needed.
Who is involved
8