Routine Site Monitoring
Routine site monitoring is a critical component of clinical trial quality management. It is the process of regularly visiting the study sites to review the conduct of the study and to ensure that the study is being conducted in accordance with the study protocol, Good Clinical Practice (GCP), and applicable regulatory requirements.
Routine site monitoring involves the following activities:
- Review of study conduct: The monitor reviews the conduct of the study at the site, including the enrollment of eligible subjects, the administration of study interventions, the collection and management of study data, and the management of adverse events.
- Review of study documentation: The monitor reviews the study-related documentation at the site, including the informed consent forms, case report forms (CRFs), subject medical records, and laboratory data, to ensure that they are complete, accurate, and consistent with the study protocol.
- Review of study compliance: The monitor assesses the site’s compliance with the study protocol, GCP, and applicable regulatory requirements, and provides feedback and guidance to the site on any identified issues.
- Follow-up on previous monitoring findings: The monitor follows up on any previously identified issues or actions and verifies that they have been addressed and resolved.
- Reporting: The monitor prepares a monitoring report that documents the findings and observations from the site visit, and provides recommendations for improvement, if necessary.
Routine site monitoring is an ongoing process that occurs throughout the study, and it is critical to ensure the quality and integrity of the study data and to protect the rights, safety, and welfare of the study subjects. The frequency and intensity of site monitoring can vary depending on the complexity and risk profile of the study, but it is generally performed on a regular basis, such as every 3-6 months.
In addition to routine site monitoring, other types of monitoring, such as centralized monitoring or remote monitoring, may be used to supplement the site monitoring activities and to ensure the quality and integrity of the study.
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