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3.2 Data and Safety Monitoring

Last Revised 8/19/2026

For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Data and Safety Monitoring

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for data and safety monitoring for non-exempt research.

2.0 Policy

It is the policy of the Organization that all non-exempt research must have an appropriate plan for data and safety monitoring in consideration of the nature and risk profile of the research. The Data and Safety Monitoring Plan (DSMP) may or may not include a formal Data and Safety Monitoring Board (DSMB).

Note: for the purpose of this policy, DSMB is synonymous with Data Monitoring Committee (DMC) or Data and Safety Monitoring Committee (DSMC).

3.0 Investigator Responsibilities

  • 3.1. The PI will develop a Data and Safety Monitoring Plan (DSMP) in consideration of the nature and risk profile of the research.
    • 3.1.1. The DSMP will include, as appropriate, elements such as:

      • 3.1.1.1. The specific data that will be reviewed, the frequency of the review, and the duration of the review.

      • 3.1.1.2. Who will conduct the review.

        Note: in consideration of the design and risk profile of the research, monitoring may be performed by the investigator and/or study staff, by a faculty advisor, by a sponsor appointed medical monitor or CRO, by an independent monitor or monitoring group (not directly involved with the design and conduct of the study), or by a formal Data and Safety Monitoring Board (DSMB).

      • 3.1.1.3. The conditions under which specific subjects should be withdrawn from the research.

      • 3.1.1.4. The conditions under which the study will be halted (that is, study stopping rules based on efficacy, toxicity and futility)

    • 3.1.2. Under certain circumstances, the data and safety monitoring plan may include a formal Data Safety Monitoring Board (DSMB).
      • 3.1.2.1. In general, a formal DSMB is required for:
        • 3.1.2.1.1. Phase III clinical trials (with the exception of low-risk behavioral and nutritional studies, where subjects are expected to experience only minor side effects, and interim analyses are not crucial for the protection of subjects).
        • 3.1.2.1.2. Multicenter randomized phase II clinical trials (with the exception of low-risk behavioral and nutritional studies).
        • 3.1.2.1.3. High risk phase II clinical trials (such as those involving interventions associated with risk of serious morbidity or death, studies involving diseases associated with high mortality or morbidity, and research involving highly experimental therapies).
      • 3.1.2.2. In consideration of the specific nature and risk profile of the research, a formal DSMB may also be appropriate for:
        • 3.1.2.2.1. Research involving a large study population, or multiple study sites.
        • 3.1.2.2.2. Research intended to provide definitive information about effectiveness and/or safety of an intervention.
        • 3.1.2.2.3. Research which involves an intervention with the potential to induce unacceptable toxicity.
        • 3.1.2.2.4. Research which evaluates mortality or another major endpoint, such that inferiority of one treatment arm has safety as well as effectiveness implications.
        • 3.1.2.2.5. Research for which it would ethically be important for the trial to stop early if the primary question addressed has been definitively answered, even if secondary questions or complete safety information were not yet fully addressed.
        • 3.1.2.2.6. Research involving a particularly vulnerable population, for whom closer monitoring will provide additional meaningful protection.
  • 3.2. The PI is responsible for reviewing the results of data and safety monitoring (including but not limited to DSMB reports) at the frequency described in the approved IRB application.
  • 3.3. The PI is responsible for making revisions in a timely manner in the protocol and/or informed consent documents as appropriate based on results of data and safety monitoring and/or formal DSMB reports
  • 3.4. The PI is responsible for submitting copies of all DSMB reports to the IRB at the time of continuing review (or interim reporting period as mandated by the IRB).

4.0 IRB/ORA Responsibilities

  • 4.1. The IRB will evaluate the DSMP proposed at the time of initial review (or with any subsequent modifications) to ensure that it includes adequate provisions for monitoring the data collected to ensure the safety of subjects.
  • 4.2. For studies that do not have a DSMB as part of the DSMP the IRB will determine whether a DSMB would provide meaningful additional protection for subjects.
  • 4.3. The IRB will review DSMB reports submitted at time of continuing review (or interim reporting period as mandated by the IRB) to determine whether the regulatory criteria for approval continue to be satisfied and the rights and welfare of subjects continue to be protected. If the IRB finds approval criteria are no longer met, or subject’s rights or welfare are no longer adequately protected, the IRB will take appropriate actions in accordance with HRPP policy 8.6 (Study Hold, Suspension, and Termination).
  • 4.4. If the DSMB report is due but has not been submitted to the IRB at the time of continuing review (or interim reporting period as mandated by the IRB), the IRB may table the Continuing Review, or may suspend the study in accordance with HRPP policy 8.6 (Study Hold, Suspension, and Termination.

DOCUMENT HISTORY:

 Written: 4/4/2016 (Approved: 4/4/2016) - original author not recorded

 Revised: 2/2/2018 - revision not documented

 Revised: 12/22/2022 – Clarified expected contents of DSMP; other revisions to eliminate duplicate text and for clarity.

 Revised 8/19/2026 – stylistic changes

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