3.2 Data and Safety Monitoring
Last Revised 12/22/20228/19/2026
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 levelprofile 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 3.1.consideration The DSMP must be developed to fitof the
designnature and risk profile of the research.
Itshould3.1.1. The DSMP will include, as appropriate, elements such as:
reviewed, 3.1.2. Thethe frequency
of the review, and
the duration of
reviewthe (whenreview.
monitoring
wil
start3.1.1.2. and when itWho will end).
3.1.3. The identities ofconduct the
personsreview.
orNote: groupsin conductingconsideration the review
3.1.4. The conditions under which specific subjects should be withdrawn
3.1.5. As appropriate based onof the design and risk profile of the research,
themonitoring conditions under which the study willmay be
halted (that is, study stopping rules based on efficacy, toxicity and futility)
3.2. The DSMP may include monitoringperformed 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
DSMB.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 The conditions under which specific subjects should be withdrawn from the research.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)
4.0
3.1.2. Under certain circumstances, the data and safety monitoring plan may include a formal Data Safety Monitoring Board (DSMB)
.
4.3.1. Under certain circumstances, the IRB or the investigator may decide that the DSMP should include a formal DSMB.
4.1.2.1. In generalgeneral, a formal DSMB is required for:
4.3.1.2.1.1. Phase III clinical trials,trials (with the exception of low-risk behavioral and nutritional studies (such as thosestudies, where subjects are expected to experience only minor side effects, and interim analyses are not crucial for the protection of subjects).4.3.1.2.1.2. Multicenter randomized phase II clinical trials,trials (with the exception of low-risk behavioral and nutritional studies.studies).4.3.1.2.1.3. 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).
4.3.1.2.2. In consideration of otherthe trials,specific nature and risk profile of the research, a formal DSMB shouldmay also be consideredappropriate for the following types of research:for:
4.3.1.2.2.1. Research involving a large study population, or multiple study sites.4.3.1.2.2.2. Research intended to provide definitive information about effectiveness and/or safety of a medicalan intervention.4.3.1.2.2.3. Research which involves an intervention with the potential to induce unacceptable toxicity.4.3.1.2.2.4. Research which evaluates mortality or another major endpoint, such that inferiority of one treatment arm has safety as well as effectiveness implications.4.3.1.2.2.5. 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.4.3.1.2.2.6. Research involving a particularly vulnerable population, for whom closer monitoring will provide additional meaningful protection.
5.0
3.2. ReviewThe ofPI is responsible for reviewing the
DSMP by the IRB
5.1. The IRB will consider the adequacyresults of
the DSMP based on the conditions described in section 3.1 above.
5.2. For studies that do not have a data monitoring committee the IRB will carefully review the data and safety monitoring
plan(including andbut determinenot whetherlimited a data monitoring committee would provide meaningful additional protection for subjects.
5.3. If the research design or risk profile warrants a formalto DSMB
the investigator must provide the DSMB charter, or describe (1) the composition of the DSMB membership, (2) the frequency of DSMB meetings and reports. It is expected that most studies which require a formal DSMB will also have formal stopping rules for efficacy and toxicity.
5.4. The IRB will evaluate the DSMP in order to ensure that it represents adequate provision for monitoring the data collected to ensure the safety of subjects.
6.0 Review of DSMB Reports by the IRB
6.1. It is the responsibility of the investigator to obtain copies of, and review, DSMB reports, as they are produced,reports) at the frequency described in the approved IRB application.
6.2.3.3. 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
6.4.1. 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
DSMB reportIRB finds
seriousapproval riskscriteria toare theno longer met, or subject’s rights or welfare
ofare subjects,no orlonger recommendsadequately substantive changes to the protocol (including but not limited to halting of the protocol or accrual) or substantive changes to the informed consent document, then the investigator must submit the report promptly to the IRB. It is expected that such DSMB reports will be followed promptly by a Request for Change in protocol.
6.4. If the DSMB finds serious risks to the welfare of subjects,protected, the IRB will take
actionappropriate actions in accordance with
HRPP policy 8.6 (Study Hold, Suspension, and Termination).
6.5.4.4. 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
