Per ICH-GCP, monitoring activities include source data verification, review of regulatory documents, and follow-up on deviations or safety issues. Risk-based monitoring (RBM) focuses effort on critical data and processes.
← Back to Glossary
Glossary Term
Clinical Research Associate (CRA / Monitor)
Clinical Operations
Also known as: CRA, clinical monitor, study monitor
The sponsor or CRO representative responsible for monitoring trial sites to verify compliance, data accuracy, and subject protection.
Need IRB review for your study?
Elemental IRB provides fast, transparent ethical oversight for commercial and academic research.