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- What is Monitoring?
- Where is it used in clinical trials?
- How does Clinion implement it?
- What does it look like in practice?
- Related Terms
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What is Monitoring?
Monitoring is the ongoing oversight of a clinical trial to confirm that the study is conducted according to the clinical trial protocol, Good Clinical Practice (GCP), and regulatory requirements. It focuses on verifying subject safety, the accuracy and completeness of trial data, and adherence to approved procedures through activities such as site visits, source data review, and issue follow-up.
Where is it used in clinical trials?
Monitoring is used throughout the entire clinical trial lifecycle, from study initiation to close-out. It is applied during site initiation visits to confirm readiness and protocol understanding, during ongoing trial conduct to review subject safety, verify informed consent, and check data accuracy, and during close-out to ensure all study activities are completed. Monitoring supports compliance with the clinical trial protocol, Good Clinical Practice (GCP), and regulatory requirements across all study sites. It also helps identify risks early, resolve deviations, and maintain overall study quality.
How does Clinion implement it?
Clinion facilitates monitoring by streamlining how site oversight activities are planned and executed within a single system. It allows monitors to manage visit schedules, review study data remotely, and document observations in a structured manner. The platform supports tracking of findings, action items, and resolutions, giving study teams continuous visibility into site compliance, data quality, and overall trial progress in line with GCP expectations.
What does it look like in practice?
During an ongoing study, a monitor uses Clinion to plan site visits, review subject data, and check protocol compliance remotely. Findings such as missing data or deviations are recorded in the system and assigned for resolution. Site staff respond to these items within Clinion, allowing monitors to track progress, close issues, and maintain continuous oversight of trial activities.
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CTMS