Sites & Operations
Clinical Trial Monitoring
Clinical trial monitoring is the act of overseeing the progress of a clinical trial and ensuring it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and applicable regulatory requirements.
FDA's 2013 Guidance on Risk-Based Monitoring (and ICH E6(R3)) endorse a shift away from 100% source-data verification toward risk-based, centralized monitoring that uses data analytics to target on-site visits where risk is highest.
Monitoring activities are documented in monitoring visit reports (MVRs) and the Trial Master File. Common monitoring approaches include on-site monitoring, remote monitoring, centralized statistical monitoring, and source data review.
Related terms
Good Clinical Practice (ICH E6(R3))
Good Clinical Practice (GCP), as defined in ICH E6(R3), is the international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human participants.
Trial Master File (TMF)
The Trial Master File (TMF) is the collection of essential documents that individually and collectively permit evaluation of the conduct of a clinical trial and the quality of the data produced, maintained by the sponsor and the investigator throughout and after the trial.
Site Qualification Visit (SQV)
A Site Qualification Visit (SQV) is the on-site or remote evaluation conducted by a sponsor or CRO before site activation, to confirm that a candidate site has the personnel, facilities, processes, and patient access required to conduct the planned clinical trial in compliance with GCP.
Electronic Data Capture (EDC)
Electronic Data Capture (EDC) is the system used to collect, manage, and store clinical trial data electronically via electronic case report forms (eCRFs), replacing paper-based data collection.
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