What is it? Why is it important?

The Data Safety Monitoring Board (DSMB) consists of an independent group of experts that regularly review the safety and, when appropriate, the efficacy data of a study.

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

More

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
  • 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)
  • Reduce the ongoing risk of major adverse health outcomes

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

References

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
Abbreviations
  • 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
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

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

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