Clinical Study Oversight Committee (CSOC) Guidelines
Guidance for the Clinical Study Oversight Committee (CSOC), an independent group of experts that advises NIDCR and study investigators on clinical studies not involving an intervention.
Final
Issued by: National Institutes of Health (NIH)
Issue Date: July 01, 2018
Clinical Study Oversight Committee Guidelines
I. Roles and Responsibilities
The Clinical Study Oversight Committee (CSOC) is an independent group of experts that advises NIDCR and study investigators on clinical studies not involving an intervention. Such clinical research studies may be complex, involve risk or vulnerable populations, and may be observational, specimen collection, epidemiology or surveillance studies. The responsibilities of the CSOC are to 1) monitor human subject safety by reviewing and evaluating the accumulated study data, 2) review study conduct and progress, and 3) make recommendations to NIDCR concerning the continuation, modification, or termination of the study. The CSOC considers study-specific data as well as relevant background information about the disease, procedures and progress of the study.
Prior to the first data review and preferably prior to study initiation, the CSOC should define its deliberative processes. These may include event triggers or a process that would call for an ad hoc review, milestones expectations, endpoint analysis, and voting procedures. The CSOC is also responsible for maintaining the confidentiality of its internal discussions and activities as well as the contents of reports provided to it.
The CSOC should review the protocol, including the oversight and risk monitoring plan, and identify any major concerns prior to implementation. During the study the CSOC should review:
- Real-time and cumulative safety data for evidence of procedure-related adverse events
- Unanticipated problems involving risks to subjects or others (for additional information, see Office for Human Research Protections)(link is external)
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