Independent Data-Monitoring Committee (IDMC, also known as Data and Safety Monitoring Board (DSMB) or Data and Safety Monitoring Committee (DSMC)) – is an impartial group of experts responsible for reviewing and assessing ongoing clinical trial data. Their primary role is to ensure participant safety, data integrity, and ethical conduct throughout the trial, providing recommendations to the trial sponsor based on their analyses.
By maintaining autonomy and a vigilant approach, the IDMC contributes to upholding the ethical and scientific standards of clinical research, safeguarding the well-being of participants, and enhancing the credibility of trial outcomes.
Definitions
ICH E6(R2)
- ICH E6 1.25 Independent Data-Monitoring Committee:
- An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial [1].
Role of data monitoring committee
A clinical trial DMC is a group of individuals with pertinent expertise that reviews on a regular basis accumulating data from one or more ongoing clinical trials. The DMC advises the sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial [2].
See also
Another relevant pages
Links to this page
- Independent Data-Monitoring Committee (redirect page) (← links)
- DSMB (redirect page) (← links)
- Well-being (← links)
References
- ↑ ICH, 2016, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf Accessed Sep 2023
- ↑ FDA, 2006, Guidance for clinical trial sponsors: Establishment and operation of clinical trial data monitoring committees. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishment-and-operation-clinical-trial-data-monitoring-committees Accessed Apr 2024
External links