Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Terms of reference for Data and Safety Monitoring Committees.

M Packer1, J Wittes, D Stump

  • 1Division of Circulatory Physiology, Columbia-Presbyterian Medical Center, 5-435, 177 Fort Washington Ave., New York, NY 10032, USA. mp65@columbia.edu

American Heart Journal
|March 29, 2001
PubMed
Summary

Understanding the Data and Safety Monitoring Committee (DSMC) is crucial for clinical trials. Clear comprehension of DSMC functions prevents confusion and ensures trial integrity.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Zalunfiban at First Medical Contact for ST-Elevation Myocardial Infarction.

NEJM evidence·2025
Same author

Bespoke magnetic field design for a magnetically shielded cold atom interferometer.

Scientific reports·2022
Same author

Acute, non-COVID related medical admissions during the first wave of COVID-19: A retrospective comparison of changing patterns of disease.

Acute medicine·2020
Same author

[What will cataract surgery look like in the future? Alternatives in the pipeline].

Journal francais d'ophtalmologie·2020
Same author

Object surveillance with radio-frequency atomic magnetometers.

The Review of scientific instruments·2020
Same author

Contrasting effects on the risk of macrovascular and microvascular events of antihyperglycemic drugs that enhance sodium excretion and lower blood pressure.

Diabetic medicine : a journal of the British Diabetic Association·2018

Area of Science:

  • Clinical Trials
  • Regulatory Science
  • Public Health

Background:

  • The Data and Safety Monitoring Committee (DSMC) is a complex but vital component of clinical trial oversight.
  • Effective functioning of the DSMC is essential for the ethical and scientific integrity of research.
  • Misunderstanding the DSMC's role can impede trial progress and impact participant safety.

Framework:

  • The DSMC's primary function is to monitor participant safety and trial data.
  • Key responsibilities include reviewing interim results and making recommendations on trial continuation, modification, or termination.
  • A clear framework for DSMC operations ensures transparency and accountability.

Implementation:

  • Successful DSMC implementation requires clear communication channels between the committee, investigators, sponsors, and regulatory bodies.

Related Experiment Videos

  • Standardized protocols for data review and decision-making are critical for efficient operation.
  • Training for all trial stakeholders on DSMC procedures is paramount.

    • Implications:

    • Proper understanding and implementation of DSMC roles minimize confusion and potential conflicts.
    • Effective DSMC oversight safeguards participant well-being and data validity.
    • Clear DSMC functions support regulatory compliance and public trust in clinical research.