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AgendaHealthcareBoard & governance

Data safety monitoring board (DSMB) meeting

150 minutes 12 blockspro Runs with Pro

A DSMB agenda with open, closed and executive sessions kept apart, an anonymous straw vote on the recommendation and a clean written record.

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Free to open and edit. Running it live needs Pro, free for 14 days on every new account.

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150 min · 12 blocks, drawn to scale Fits exactly
  1. Welcome, roll call and conflict of interest statements, 5 minutes 5
  2. Approve the agenda and the open minutes of the last meeting, 3 minutes 3
  3. Open session: study status from the sponsor and investigators, 20 minutes 20
  4. Open session: data quality, protocol deviations and pooled safety, 15 minutes 15
  5. Open session: questions to the sponsor and study team, 10 minutes 10
  6. Closed session: the unblinded statistician presents data by arm, 30 minutesInfo 30
  7. Closed session: benefit and risk, 20 minutes 20
  8. Executive session: members only, 10 minutes 10
  9. Executive session: straw vote on the recommendation, 5 minutes 5
  10. Agree the wording of the written recommendation, 15 minutes 15
  11. Debrief: the chair gives the recommendation to the sponsor, 10 minutes 10
  12. Next review date, actions and minutes, 7 minutes 7
03875113150 min
  1. +0′Welcome, roll call and conflict of interest statementsTip: Each member confirms any new financial or professional conflict since the last meeting. Record it in the open minutes.5 minInfo
  2. +5′Approve the agenda and the open minutes of the last meeting3 minDecide
  3. +8′Open session: study status from the sponsor and investigatorsTip: Enrollment against target, site activation, retention, protocol amendments since the last review. Pooled data only, never by arm.20 minInfo
  4. +28′Open session: data quality, protocol deviations and pooled safetyTip: How current is the data? A safety review on stale data is weak; ask for the data cut-off date and the share of visits entered.15 minInfo
  5. +43′Open session: questions to the sponsor and study teamTip: The sponsor, investigators and blinded statisticians leave after this block.10 minDiscuss
  6. +53′Closed session: the unblinded statistician presents data by armTip: Members and the unblinded statistician only. Safety and efficacy by arm, and any interim analysis against the stopping boundaries in the charter. Keep the numbers in the closed report; don't type them into the agenda or the summary.30 minInfo
  7. +83′Closed session: benefit and riskTip: Ask: is there a safety signal, is the trial still able to answer its question, and has anything outside the trial changed the picture?20 minDiscuss
  8. +103′Executive session: members only10 minDiscuss
  9. +113′Executive session: straw vote on the recommendationWhat should we recommend to the sponsor?Tip: Anonymous, so junior members aren't swayed by the chair. The charter sets how the final recommendation is reached, often by consensus.5 minVote
  10. +118′Agree the wording of the written recommendationTip: The letter states the recommendation and any modifications without unblinded results. The chair signs it.15 minDecide
  11. +133′Debrief: the chair gives the recommendation to the sponsorTip: Back in open session. Answer questions about the recommendation, not about the comparative data.10 minInfo
  12. +143′Next review date, actions and minutesTip: Open and closed minutes are kept separately. Closed minutes stay confidential until the trial ends.7 minWrap-up

In short

A data safety monitoring board (DSMB) is an independent group of experts that reviews accumulating trial data to protect participants and the trial's integrity. This 150-minute agenda separates the open, closed and executive sessions, adds an anonymous straw vote on the recommendation and ends with a written recommendation to the sponsor.
Time
150 minutes
Sessions
Open, closed, executive
People
3 to 7 members plus a statistician
Plan
Pro

Updated October 4, 2026

What's inside

By the end of this meeting, the board has reviewed the trial's safety and progress, agreed its recommendation and recorded it for the sponsor without disclosing unblinded data. The full agenda is drawn to scale above: every block has its own timer when you run it live.

How to run it

  1. 1Send the open and closed reports by the deadline in the charter, through separate channels so blinded staff never receive closed data.
  2. 2Use the agenda to keep the open, closed and executive sessions strictly apart, and tell people when to leave the call or room.
  3. 3Run the closed session from your secure data system; use Agendiq for the timers and the anonymous straw vote, not for unblinded numbers.
  4. 4Agree the recommendation letter's wording before the debrief so the chair says exactly what will be written.
  5. 5Keep open and closed minutes in separate files, as your charter requires.

Questions people ask

What is the difference between open and closed sessions at a DSMB meeting?
In the open session the sponsor and investigators present pooled study status. In the closed session only the members and the unblinded statistician review data by treatment arm.
Who sits on a data safety monitoring board?
Clinicians with expertise in the disease, at least one biostatistician and sometimes an ethicist or patient advocate. Members are independent of the sponsor and the investigators.
What can a DSMB recommend?
Continuing the trial unchanged, continuing with modifications, pausing enrollment, or stopping early for safety, clear benefit or futility. The sponsor makes the final decision.

Run it with your group

pro
  • A timer for every block on the shared screen
  • Results, decisions and actions in the summary
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Free to open and edit. Running it live needs Pro, free for 14 days on every new account.

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