A For-Cause Monitoring (FCM) Visit is a targeted clinical trial monitoring visit conducted in response to a specific concern, identified risk, or potential issue at a research site. Unlike routine monitoring visits performed according to a planned schedule, an FCM visit is initiated when circumstances indicate that additional review or oversight may be necessary.
Reasons for an FCM visit may include significant or repeated protocol deviations, concerns about informed consent or participant safety, data quality or integrity issues, regulatory noncompliance, unusual enrollment patterns, inadequate investigational product accountability, or findings identified through audits, monitoring activities, or other quality oversight processes.
During the visit, the monitor may conduct a focused review of relevant study records, source documentation, regulatory files, site procedures, and staff practices to better understand the issue and determine its scope. Findings from an FCM visit may result in additional training, increased monitoring, corrective and preventive actions (CAPAs), or other measures designed to address identified concerns.
For-cause monitoring helps sponsors identify and address potential risks, strengthen study oversight, and support participant protection, regulatory compliance, and the integrity of clinical trial data.