The primary functiony of the SMC is to monitor participant safety.
1)Periodically review and evaluate the accumulated study data for participant safety, study conduct and progress, and, when appropriate, efficacy, and
2) Make recommendations to DMID concerning the continuation, modification, or termination of the trial. DSMBs meet regularly and whenever any special need arises to review study conduct and cumulative study data, and to recommend whether the study should continue without change, be modified, or be terminated.. Investigators and POs should consider having at least one member of the SMC serve as an Independent Safety Monitor (see below).
3)The SMC must be able to convene on an ad hoc basis when immediate safety concerns arise. Its members may be from the investigator’s institution or other participating sites but should not be directly involved with the trial or under the investigator’s supervision..
4)The SMC considers study-specific data as well as relevant background information about the disease, test agent, and target population under study.
5)The SMC is also responsible for maintaining the confidentiality of its internal discussions and activities as well as the contents of reports provided to it.
6)The SMC should review the protocol, including the safety monitoring plan, and identify any major concerns prior to implementation. During the trial the SMC should review:
- Real-time and cumulative safety data for evidence of study-related adverse events;
- Adherence to the protocol;
- Factors that might affect the study outcome or compromise the trial data (such as protocol violations, losses to follow-up, etc.); and,
- Data relevant to proceeding to the next stage of the study, if applicable.
The SMC should conclude each review with each member’s recommendation to DMID as to whether the study should continue, be modified, or be terminated. Recommendations regarding modification of the design and conduct of the study may include corrective actions when performance is unsatisfactory, or recommendations to advance to the next dose in a dose escalation study, for example, or to the next stage in product testing.
Confidentiality must always be maintained during all phases of SMC review and deliberations. For masked studies, only members of the SMC and study biostatisticians should have access to the emerging study data.