Clinical trials monitoring
Clinical trials monitoring
Monitoring is defined as the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures, The Principles of Good Clinical Practices, and the Medicines for Human Use (Clinical Trials) Regulations – where applicable.
The purpose of monitoring is to verify that:
- The rights and well-being of the human subjects are protected
- The reported trial data are accurate, complete and verifiable from source documents
- The conduct of the trial is in compliance with the currently approved
protocol/amendment(s), GCP and the applicable regulatory requirements.
RSC has an experienced Senior Clinical Research Associate who monitors clinical trials, and
offers clinical trial pharmacy Services
