Data & Quality
Data Monitoring Committee (DMC)
A Data Monitoring Committee (DMC), also called a Data and Safety Monitoring Board (DSMB), is an independent group of experts that periodically reviews accumulating trial data to safeguard participant safety, study integrity, and scientific validity.
DMCs are required for most large, blinded, randomized trials and for any trial with serious mortality or morbidity risk. The committee operates under a charter that defines membership, meeting cadence, voting rules, and escalation procedures.
FDA's 2024 guidance on Use of Data Monitoring Committees and the EMA's 2005 guideline set independence and conflict-of-interest expectations.
References
Related terms
Interim Analysis
An interim analysis is a pre-planned statistical evaluation of accumulating clinical trial data while the trial is ongoing, used to assess efficacy, futility, safety, or to trigger sample-size adaptation.
Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is the international ethical and scientific quality standard, codified in ICH E6, for designing, conducting, recording, and reporting clinical trials that involve human participants.
Adverse Event (AE)
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant administered a pharmaceutical product, regardless of whether it is considered related to the product.
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