Glossary Term
Data Safety Board (DSMB)
Definition
A Data Safety Monitoring Board (DSMB) is an independent group of experts tasked with overseeing the safety of participants and the integrity of data in a clinical trial. The DSMB reviews interim data and monitors for adverse events, making recommendations to continue, modify, or terminate the study based on predefined criteria.
Relevance to the MedTech Industry
The DSMB ensures that clinical trials adhere to ethical standards and maintain participant safety while producing reliable data. For MedTech companies, the DSMB provides an impartial assessment that supports regulatory submissions and enhances stakeholder confidence in the trial process.
Additional Information & Related Terms
Clinical Trial Design Incorporates the DSMB’s role in safety and data monitoring.
Adverse Event (AE) A key metric monitored by the DSMB to ensure participant safety.
Good Clinical Practice (GCP) Ensures that DSMB activities align with ethical and scientific standards.
Post-Market Clinical Follow-Up (PMCF) DSMBs may oversee safety and efficacy in post-market studies.