For any trial to reach its conclusion, monitors are crucial. Whereas auditing serves a quality assurance (QA) function, monitoring provides quality control (QC), through which study conduct is checked, step by step. Simply put, monitors aim to detect issues and rectify them, preventing existing errors from recurring and new ones from developing. Before, during, and after the trial, monitors assess whether what is planned, described, and approved is realised as intended.
Every trial must be conducted, recorded, and reported correctly, meaning that it should adhere to protocol, Standard Operating Procedures, Good Clinical Practice, and the relevant regulatory requirements – all of these being aspects of QC. Monitoring was developed internationally as a profession to render trials more cost effective, of higher quality, and ultimately to help them reach conclusive results. Monitors are effectively guardians of both processes and people. They oversee that trial data is accurate, complete, and verifiable, while checking that the rights of participants are protected. When both processes and people are protected in this way, more trials can run to completion.