Data and Safety Monitoring Plans (DSMPs) are written plans that describe how the conduct and progress of a study is overseen and monitored. The goal of this plan is to:
Per OHSP Policy 506: Data & Safety Monitoring, DSMPs are required for all research posing greater than minimal risk and may be required for studies involving minimal risk, depending on the nature of the study.
Principal Investigators (PI) are responsible for the development of DSMPs. Based on the nature, size, and complexity of the research, DSMPs can range from a simple plan where the PI periodically reviews safety data to a more extensive plan that involves a Data & Safety Monitoring Committee (DSMC).
At a minimum, DSMPs should identify the:
Things to consider when developing a DSMP
DSMPs must comply with institutional requirements, as well as, any other applicable regulatory agencies and study sponsors (e.g., Food & Drug Administration, National Institutes of Health).
In accordance with Reviewing IRB policy, all studies, regardless of risk-level or intervention require monitoring and reporting of research events to ensure subject safety (e.g., reference OHSP Policy 801: Reporting Research Events). Only those studies that are greater than minimal risk require formal DSMPs.
The level of monitoring must be commensurate with the nature of the study. DSMPs that are insufficient may inadvertently increase risks to subjects while DSMPs that are too extensive may run ineffectively, thereby increasing risks to subjects, or set study teams up for a compliance problem by not following the plan. Examples of appropriate monitoring levels based on risk are provided in Appendix 1 of OHSP Policy 506: Data & Safety Monitoring.
The responsibilities of a committee will depend on the nature of the study. Generally, responsibilities should include interim monitoring for efficacy, safety, study conduct (e.g., recruitment & retention, non-compliance, completeness of the data) and continued relevance of the study question.
Generally, safety monitors and committee members should be free of any conflicts of interest (with the study and study sponsors) and have relevant expertise based on the role they serve within the DSMP.
Once a study is approved, the PI is responsible for ensuring adherence to the DSMP plan, as described in the study protocol and IRB application. As with all study procedures, documentation to demonstrate the execution of the DSMP must be maintained. Best documentation practices include maintaining:
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