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Office for Human Subject Protection
Office of the Vice President for Research

Data and Safety Monitoring Plans

Data and Safety Monitoring Plans (DSMPs) describe the oversight and monitoring of study conduct. The goal of this plan is to ensure:

  • That important information that may affect the safety or welfare of subjects is collected, reviewed and acted upon as quickly as possible;
  • The validity and integrity of the research data; and
  • The continued scientific merit of the research.

Per Office for Human Subject Protection (OHSP) Policy 506: Data & Safety Monitoring, formal (written) DSMPs:

  • Are required for all research posing greater than minimal risk
  • May be required for studies involving minimal risk, depending on the nature of the study.

 

Developing an appropriate DSMP

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:

  • Individual(s) responsible for monitoring;
  • Process for conducting the monitoring;
  • Mechanism for documenting the monitoring; and
  • Who will be notified of the outcome of the monitoring activity (e.g., Institutional Review Board [IRB], study sites, sponsor).

Things to consider when developing a DSMP

Have you complied with all of the applicable policies/requirements?

As applicable, DSMPs must meet:

  • institutional requirements,
  • regulatory requirements (e.g., Food & Drug Administration), and
  • sponsor/funding agency requirements (e.g., National Institutes of Health).
Are you confusing DSMPs with general safety monitoring?

Regardless of risk-level, all study teams must monitor for research events that could impact subject safety. Reviewing IRB policy defines the types of research events that must be reported to the Reviewing IRB. E.g., the RSRB requires the reporting of all events deemed unanticipated, related and serious events. Adherence with these policies is required regardless of what a DSMP details.

For greater than minimal risk research, DSMPs may include this type of monitoring and reporting, but it is not, in and of itself, a DSMP.

Have you critically assessed the appropriateness of the DSMP based upon the study procedures and their associated risks?

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.

If a DSMC will be formed, what will be their responsibilities?

The responsibilities of a DSMC (or any other type of monitoring 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.

Who will act as a Safety Monitor or serve on the DSMC?

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.

Complying with a 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 must be maintained to demonstrate the execution of the DSMP. Best documentation practices include maintaining:

  • A written summary of each meeting or data review, noting the date/time and venue of communication (e.g., in-person, teleconference, etc.), participant list and any recommendations resulting from the meeting. A template for doing so is available via OHSP’s Templates. Additional templates/examples are readily available via internet searches, as well.
  • Documentation of communications to study sites, IRBs, sponsors and regulatory agencies.
  • Documentation of DSMC member and/or Safety Monitor training/experience (e.g., curriculum vitae) and conflict of interest disclosure.

Related resources

training

UR-HRPP Educational Forums

The archived UR-HRPP Educational Forums identified below are available in Blackboard. To access recordings, follow our Blackboard Self-Enrollment Instructions and enroll in the course titled ‘UR-HRPP Educational Materials’.

  • 3/12/2020 – Adverse Events through the Lens of the IRB
  • 12/16/2014 – Planning for Your Plan: Data and Safety Monitoring Plan Development & Implementation

external resources