Tubestop - Trial Monitoring / Study Oversight

Description

Clinical trial monitoring is conducted in alignment with the clinical monitoring plan created for the protocol. It is a critical part of clinical trial oversight by research sponsors. Clinical trial monitoring is typically conducted by a clinical research associate (CRA).

The CRA will review the study protocol, GCP guidelines, and applicable regulatory requirements.
The CRA will then visit the clinical trial site to observe the conduct of the study, to discuss study conduct with the trial staff, to review study documentation and data collection, and to discuss any concerns with the study staff.
The CRA will prepare a monitoring report that summarizes the findings of the monitoring visit which is reviewed by the study sponsor and the study investigators.
Any necessary corrective actions will be taken and documented.

Clinical trial monitoring is an important quality assurance process that helps to ensure the integrity of clinical trials, ensuring clinical trial data quality and protocol compliance to regulatory and ethical standards.

DCT-specific Considerations/Inputs

Monitoring decentralized clinical trials includes some process changes to access and review data.

Increased use of technology: Decentralized clinical trials rely on technology to collect data and communicate with participants. Therefore, it is important to use technology to support the monitoring process. This may include using eSource data capture tools, electronic data capture (EDC) systems, remote patient monitoring (RPM) devices (e.g., wearables), and telehealth visits. The data is ideally accessible in a single platform, and may actually simplify monitoring for data completeness and accuracy.
Remote monitoring: Decentralized clinical trials enable more remote monitoring than traditional clinical trials.. Therefore, it is important to develop a comprehensive remote monitoring plan that includes strategies to track participants' progress, identify any problems, and address any concerns.. This includes any monitoring needs to review data collected at any HCP or alternative site locations (e.g., mobile research units, pharmacy based clinical trial units, in-home data collection, etc)

U.S. FDA Final Guidance Document: Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties - September 2024

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Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies

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