Clinical Research Monitoring/ Quality Assurance
Monitoring is 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, SOPs, GCP and applicable regulatory requirements.
The clinical research monitor is the person with direct access to, and oversight, of the site research activities. They conduct monitoring visits in accordance with a monitoring plan and provide feedback and training to sites as necessary.
The purposes of monitoring is to ensure that:
- The rights and well being o f trial participants are protected
- The reported data are accurate, complete and verifiable in source documents
- The conduct of the trial is in accordance with the currently approved protocol/ amendments, with GCP and with current and applicable regulatory requirements
The recommended training curriculum for clinical research monitors includes:
- Clinical Trial Monitoring Basics
- Building Quality Management Systems for Sites and Sponsors
- FDA Form 1572
- eResearch Managing Clinical Trials in an Electronic Environment
- Recommended: departmental shadowing