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NIMH Policy - Data and Safety Monitoring
NIMH Policy on Data and Safety Monitoring in Clinical Trials (April 2005)
In June 1998, the National Institutes of Health (NIH) issued a policy on data and safety monitoring (http://grants.nih.gov/grants/guide/notice-files/not98-084.html) that requires oversight and monitoring of all intervention studies to ensure the safety of participants and the validity and integrity of the data. That policy notes that monitoring should be commensurate with risks, and with the size and complexity of the trials. This NIMH policy provides further guidance for monitoring of phase I and II clinical trials, or (phase 4) studies of already marketed products. It does not take the place of Institutional Review Board (IRB) guidelines, Food and Drug Administration (FDA) requirements, or special NIH guidelines (e.g., NIH Guidelines for Research Involving Recombinant DNA Molecules).
In studies of small numbers of subjects, untoward effects may readily become apparent through close monitoring of individual patients, while in larger studies, risk may best be assessed through statistical comparisons of treatment groups. The NIH requires the use of Data and Safety Monitoring Boards (DSMBs) for phase III clinical trials. For other clinical trials, a DSMB may be appropriate if the studies have multiple clinical sites, are blinded (masked), and/or employ particularly high-risk interventions or vulnerable populations.
For small-scale, single-site, NIMH-supported clinical trials, independent DSMBs may not be necessary, especially when the risk of the intervention(s) is considered relatively low. In most such studies, the Principal Investigator (PI) would be expected to perform the monitoring function as part of the general oversight and scientific leadership of the study. The PI must comply with requirements for prompt reporting of study-related toxicity and of any unanticipated problems involving risks to subjects or others. In some instances, the investigators, IRB, peer reviewers or NIMH staff may determine that an independent individual, committee, or Board is also needed for monitoring.
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