clinical trial is defined by NIH as a research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Clinical trials must be submitted to NIH through
clinical trial-specific notice of funding opportunities. As part of the application process, NIH requires a data and safety monitoring plan that is commensurate with the risks of the trial, its size and complexity. The minimal elements of a data and safety monitoring plan are described in
Section 3.3 of
G.500 – PHS Human Subjects and Clinical Trials Information and include:
In addition to the elements listed above, NIGMS recommends that all clinical trial data and safety monitoring plans address:
An independent medical monitor is a physician with relevant expertise whose primary responsibility is to review individual and cumulative adverse events and make recommendations regarding the safe continuation of the study. Use of an independent medical monitor may be sufficient oversight for small trials that are considered to be of low risk to participants. An independent medical monitor may also be used in larger trials in conjunction with a safety monitoring committee and/or a data and safety monitoring board.
A safety monitoring committee is an independent group of experts whose primary responsibility is to make recommendations based on issues that present immediate safety concerns. Safety monitoring committees may review adverse event data on a regular basis but typically do not perform interim evaluations of efficacy. Safety monitoring committees may be appointed at the initiation of a trial or convened as needed on an ad hoc basis.
Data and safety monitoring boards have broad oversight responsibilities that include but are not limited to:
All Phase III, multi-site clinical trials funded by NIGMS require oversight by an independent data and safety monitoring board. A data and safety monitoring board may also be used for oversight of Phase I or Phase II trials that:
For further information see the
Data and Safety Monitoring FAQs.
NIGMS expects medical monitors, safety committees and data and safety monitoring boards to be viewed as independent. Thus, the individuals who perform these roles must be free of financial and academic conflicts that may indicate bias towards a particular outcome. Examples of potential conflicts include but are not limited to: financial arrangements that reward a particular study outcome, proprietary interest in the intervention being tested, significant equity in the manufacturer of the intervention or recent collaborations/employment with the trial principal investigator. It is the responsibility of the individual monitor/member to promptly disclose any real or apparent conflicts to the NIGMS clinical trial liaison.
NIGMS welcomes questions and comments from potential applicants. Inquiries may be directed to:
Erica Brown, Ph.D. National Institute of General Medical Sciences National Institutes of Health 45 Center Drive MSC 6200 Bethesda, MD 20892-6200 Guidelines last updated June 3, 2020
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