Protocol Review Process for Investigator-Initiated Protocols
The General Clinical Research Center program director reviews the protocol for completeness and schedules it for review in the next monthly Scientific Advisory Committee meeting at Children's Hospital Medical Center of Cincinnati.
All members of the committee are expected to review each protocol, but two members are appointed by the GAC Chairman to serve as primary scientific reviewers, who make a detailed scientific assessment and specific recommendations with respect to approval, disapproval, or modifications. In addition, there is a biostatistical reviewer and a safety reviewer. The needs for special resources (such as nursing, dietary, and the Core services) are considered in terms of overall center resource capabilities.
The biostatistician on the Scientific Advisory Committee reviews the protocol to assess the appropriateness of the statistical analysis, including sample size calculations and methods of data analysis; and evaluates adequacy of the data management plan in collaboration with the informatics manager. The Safety Subcommittee members, including the RSA or his designee, review the protocol Data Safety and Monitoring Plan for safe, ethical conduct and regulatory compliance. If serious criticisms are encountered, the protocol is returned to the investigator for modification before re-review by the full committee.
Each approved protocol is scored on scientific merit and priority for resource use. The committee also assigns patients to the following categories:
- A (research center resources used for research purposes only)
- B (research center resources used as adjunct to routine patient care)
Once the protocol is approved, the investigator is directed to contact the GCRC Clinical Research Nurse Liaisons to begin the implementation process.
For more information, please contact Andrea Smith, administrative manager, 513-636-4273 or email at andrea.smith@cchmc.org .
