An introduction to clinical trial monitoring Clinical trial Monitoring is the procedure performed to safeguard the rights and interest of the humanvolunteers.
This procedure also ensures that the data that is recorded in clinical trials are high quality, accurate and precise.
Clinical research courses will help them conduct the clinical trials efficiently.
namely ICH GCP guidelines , schedule Y ,study protocols and other guidelines.
Furthermore, the monitoring process includes validating and verifying the informed consent process by checking the different document and source notes alongside the conduct of other procedures associate ed with the study protocols.
In addition to that, they check that the essential investigator files to see thatall essential documents as specified in ICH GCP are available and the file is up to date, and conducting source data verification which is to cross check the data filled by the site staff in the case report forms (CRFs) against source documents such as patients hospital file, previous prescriptions, patient diary etc.