Data Safety Monitoring Board (DSMB)
Data Safety Monitoring Board (DSMB)
Everything you need to know to create a DSMB.
DSMB Support we provide:
- Letter of Support (LOS) for grant applications, upon request
- Detailed review of study related documents
- Intake meeting with Principal Investigator (PI), DSMB Chair and DSMB program manager
- Initial DSMB meeting with study team, DSMB members and NIH representatives, if applicable
- Data and safety review meetings with study team, DSMB members and NIH representatives, if applicable
- Executive meetings with PI and DSMB Chair
- Ad hoc/prompt reviews for safety events
- Study Terminations
Request support for DSMB by contacting the CTSI Regulatory Knowledge and Support.
The CTSI DSMB is a group composed of a DSMB Program Chair, a DSMB program manager, a biostatistician and two to three experts in the field of research being studied. Optional DSMB members may include a clinical trial methodology expert, patient advocate and a/or bioethicist. Voting DSMB members must be free of any significant financial, scientific and academic conflict of interest with the study and study PI.
FAQs
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DSMB oversight is dependent on the complexity and risks related to the study itself. Determination of whether DSMB oversight is required is determined collaboratively by the study sponsor or steering committee, the FDA, IRB and the funding sponsor, such as the NIH. DSMB oversight will be required if any of these groups require it.
FDA guidance (PDF) requires DSMB or DSMCs for large, randomized, multi-site clinical trials and for any controlled trial that compares rates of mortality or major morbidity. They recommend weighing the need on three main categories including 1) the risk to trial participants; 2) whether a DSMB review is practical; 3) whether the DSMB will help assure the scientific validity of the trial.
The National Institutes of Health (NIH) has their own requirements for Data Safety Monitoring Plans (DSMPs) and Data Safety Monitoring Boards (DSMB), with each institute holding additional requirements. When submitting a grant application to the NIH it is impertinent that the researcher is familiar with those requirements.
The Ohio State University Institutional Policy (for support gaining access, contact April Green) requires DSMBs for study’s that involve a highly favorable or unfavorable outcome that might ethically require termination of the study before planned completion; existing data suggests the possibility of serious toxicities from the study procedure; the study involves vulnerable participants (ex. children, disadvantaged); the participant population is at an increased risk of death or serious outcome; or the study is large, of long duration and includes multiple sites.
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The level and frequency of review correlates to the level of risk involved with the research study and occurs at a minimum once per year. Each meeting lasts approximately one hour and consist of an open meeting with all the attendees and a closed meeting with only DSMB members. Preparation time for each DSMB member takes about 1-2 hours before the meeting.
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Initial Meeting
Prior to the initial meeting the DSMB members will review all study related documents, including the study protocol, consent forms and data safety monitoring plan (DSMP). They will direct any questions or concerns to the PI.
Open Meeting: The initial meeting will start with introductions of the DSMB members and study team. The DSMB Chair will review the conflict and confidentiality requirements, DSMB responsibilities and objectives and the DSMB charter. The study PI will review the study details, risks, and DSMP. An open discussion of any questions, recommendations or concerns will be completed by the DSMB members and study team.
Closed Meeting: Once all questions and concerns have been addressed, the study team will leave the DSMB meeting and the DSMB members will make the final recommendations and vote on whether the study can proceed as is, proceed with modifications, suspend until modifications are made or terminate the study.
A Summary and Recommendations letter will summarize the meeting and results of the closed session.
Data and Safety Review Meetings
Prior to the meeting the PI will prepare a DSMB report summarizing the current safety data, data quality and study enrollment. The DSMB report will be provided to the DSMB members for review prior to the DSMB meeting. They will direct any questions or concerns to the PI.
Open Meeting: The DSMB Chair will confirm if there are any new conflicts with the DSMB members. The study PI will review the safety data, data quality and study enrollment. An open discussion of any questions, recommendations or concerns will be completed by the DSMB members and study team.
Closed Meeting: Once all questions and concerns have been addressed, the study team will leave the DSMB meeting and the DSMB members will make the final recommendations and vote on whether the study can proceed as is, proceed with modifications, suspend until modifications are made or terminate the study.
Ad hoc/Prompt Reviews
Some events require prompt reporting and reviews by the DSMBs. These include events such as subject deaths while on study or unanticipated problems involving risks to subjects or others (UPIRSOs). DSMB review of these events may be completed by email or through a prompt ad hoc meeting.
Once all questions and concerns have been addressed, the study team will leave the DSMB meeting and the DSMB members will make the final recommendations and vote on whether the study can proceed as is, proceed with modifications, suspend until modifications are made or terminate the study.
Executive Meeting
A meeting with the DSMB chair and PI may occur after any of the other DSMB meetings, especially if there were any major concerns or if there are any significant changes that need to be made.
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Yes. The CTSI-DSMB is provided as a service to researchers across the university. Researchers conducting interventional oncology research are required to use the CCC-DSMC. Researchers may also create their own DSMB or use an external DSMB.
Researchers who are creating their own DSMB can review the CTSI Research Resources Toolkit for DSMB templates and resources to help them in their DSMB creation.