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The Clinical Translational Research Center project coordinator reviews the protocol for completeness and schedules it for review in the next monthly CTRC Scientific Advisory Committee meeting at Cincinnati Children’s Hospital Medical Center.All members of the committee are expected to review each protocol, but two members are appointed by the SAC chairman to serve as 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 CTRC 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 RSA or designee reviews the protocol, consent documents, and 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. Once the protocol is approved, the investigator is directed in the approval letter to contact the CTRC research nurses to begin the implementation process.
Administrative approval (prior to the meeting) will only be administered in special circumstances.
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