More to Monitoring Than Source Data Verification

What is monitoring?

According to international standard ICH Good Clinical Practice (GCP), the purposes of monitoring are to verify the protection of human subject rights and well-being and assure data integrity and compliance with clinical protocols and relevant regulatory requirements. Different types of monitoring occur throughout and are key to a successful clinical study. Clinical studies are reviewed initially and periodically by regulatory authorities and ethics committees (EC) or institutional review boards (IRB) to monitor the safety and ethical conduct of the investigation. They assess the merits of the study in the context of the subjects’ interests including their rights and well-being. Another means of monitoring for safety is use of an Independent Data Monitoring Committee (IDMC) or Data Safety Monitoring Board (DSMB), which are independent groups of experts that advise sponsors regarding the overall safety of the study. The committee evaluates interim data throughout the trial for safety, study progress, and efficacy endpoints.  Additionally, site investigators are responsible for patient safety as well as the overall conduct of the study, including monitoring of the medical status of their patients. Finally, clinical research monitoring is the responsibility of the sponsor. The sponsor assigns trained individuals who monitor for compliance throughout the clinical study.