What is it? Why is it important?

The Data Safety Monitoring Board (DSMB) consists of an independent group of experts who primarily review the safety, and if applicable the efficacy of a study. The composition of a DSMB depends on the type and complexity of the study. A DSMB charter defines membership responsibilities and describes the data to be reviewed.


The aim of the DSMB is to:

  • Review study data while the study is ongoing
  • Ensure that the safety of study participants is guaranteed at all times
  • Monitor the progress of a study (e.g. participant recruitment, ongoing safety concerns, achievement of study endpoint)
  • Provide recommendations on whether to prematurely terminate a study based on:
    • Participant safety concerns
    • The research question has been answered before study completion

Although safety assessment is an essential and integral part of any study, not all studies require a DSMB.


Although safety assessment is an essential and integral part of any study, not all studies require a DSMB. The establishment of a DSMB may be critical for studies that intend to:

  • Save lives
  • Has death as a primary endpoint
  • Involve high-risk intervention(s) to study participants with a potential high probability of early study termination due to safety or efficacy concerns
  • Embark on long-term studies, even if the focus are non-life-threatening diseases
  • Include data analysis during study conduct in order to protect participant from harm (e.g. statistical interim analysis)
  • Have multi-centre settings (e.g. more than one centre)
  • Have a blinded design (e.g. treatment and placebo group allocation in study participants is unknown)
  • Involve vulnerable persons (e.g. participants without capacity, children, pregnant women)

What do I need to do?

As a SP-INV and based on the complexity of your study:

  • Decide whether a DSMB might be warranted for your study
  • Decide on DSMB composition, ensuring the right type of experts are recruited (e.g. physician, statistician, patient advocates)
  • Ensure members are independent of the study staff, organisation or institution conducting the study
  • Write a DSMB charter signed by all parties. The charter documents the composition of the DSMB, members responsibilities, the management of the board and processes for decision making
  • As applicable, evaluate DSMB recommendations and act accordingly

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic


ICH GCP E6(R2) – see in particular guideline

  • 1.25 Definition of the DSMB


ISO 14155:2020 Medical device (access liable to cost) – see in particular sections

  • 3.17 Definition data monitoring committee
  • 6.11 Data monitoring committee
  • CTU – Clinical Trials Unit
  • DSMB – Data Safety Monitoring Board
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • SP-INV – Sponsor-Investigator
Set-Up ↦ Safety ↦ Data Safety Monitoring Board ↦ Aim

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Set-Up ↦ Safety ↦ Data Safety Monitoring Board ↦ Aim

Please note: the Easy-GCS tool is currently under construction.