Safety Oversight
The Division of Microbiology and Infectious Diseases (DMID) supports, through both the contract and grant mechanism, a large number of clinical studies and trials. All DMID studies are conducted in accordance with Department of Health and Human Services regulations 45 CFR 46, which provide for the protection of study participants. To ensure that procedures are in place to protect the safety of participants while ensuring the validity and integrity of the study, DMID has adopted policies which mandate that a safety monitoring plan be established for all clinical trials. This requirement pertains to all studies that evaluate investigational test articles, studies in which there is a potential for harm to participants, and other studies in which independent assessments are required to ensure objectivity.
The policy further elaborates that monitoring should be commensurate with risks and with the size and complexity of the trials. Generally, the National Institutes of Health requires Data and Safety Monitoring Boards (DSMBs) for Phase III clinical trials. For earlier trials (Phase I and II), a DSMB may be appropriate if the studies have multiple clinical sites, are blinded (masked), or employ particularly high-risk interventions or vulnerable populations. For other Phase I and Phase II trials, alternative formats may be utilized for monitoring.
Clinical trial safety oversight and the designated structure of either an ISM (independent safety monitor), SMC (safety monitoring committee), or a DSMB, consistent with DMID policy, should be clearly defined within the protocol.
Conflict of Interest (COI) Forms
Policies and Safety Guidelines
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