Glossary Term
Data Monitoring Committee (DMC)
Definition
A Data Monitoring Committee (DMC), also known as a Data Safety Monitoring Board (DSMB), is an independent group of experts that oversees the safety and efficacy of a clinical trial. The DMC periodically reviews trial data to ensure the safety of participants, assess the progress of the study, and determine whether the trial should continue, be modified, or be terminated based on predefined criteria.
Relevance to the MedTech Industry
The DMC ensures the ethical and scientific integrity of clinical trials by safeguarding participant safety and maintaining trial validity. For MedTech companies, DMCs provide an independent assessment of risks and benefits, supporting regulatory compliance and stakeholder confidence.
Additional Information & Related Terms
Clinical Trial Design Incorporates DMC involvement for safety and interim analysis planning.
Adverse Event (AE) A key data point reviewed by the DMC during trial monitoring.
Post-Market Surveillance DMCs may monitor safety in post-market clinical follow-up studies.
Good Clinical Practice (GCP) Ensures DMC processes adhere to ethical and scientific standards.