Site Monitoring Visits

The purpose of clinical site monitoring is to ensure that the rights and well-being of the study participants are protected, the quality and integrity of the data is maintained, and all study files and conduct of trial are in compliance with the currently approved protocol, GCP, and all applicable regulatory requirements. The sponsor of the clinical trial will send a Clinical Research Associate (CRA), or monitor, to the site to review and compare data to source documentation and/or medical records for completion and accuracy.

The CRA will also review the regulatory binder and all other study files to ensure all essential documents are present and up to date. During this visit, if errors are found or documents are missing or out of date, the monitor will discuss the discrepancies with the study staff and Principal Investigator to ensure corrections are made.

Helpful Links

ICH GCP Guidelines:

• 5.18 – Monitoring

FDA Code of Federal Regulations:

• 21 CFR 312.53 – Selecting investigators and monitors
• 21 CFR 312.62 – Investigator recordkeeping and record retention