Earlier today (11th April 2023) USFDA released final guidance on"A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers" which provides information about risk-based approaches to monitoring clinical studies of human drugs, biological products, medical devices, and combinations of these products.
As part of this guidance, recommendations are provided on how to plan a monitoring approach, develop a monitoring plan, and respond to and communicate monitoring results. This guidance also provides additional information to facilitate sponsors’ implementation of risk-based monitoring.
It is the responsibility of clinical investigation sponsors to ensure the integrity of data submitted to the FDA, as well as the rights, safety, and welfare of the participants in the investigation.
In order to manage risks to both participants and data integrity, sponsors should implement a risk management system throughout all stages of the study. A risk-based monitoring approach tailored to each clinical investigation's potential risks should be included in this system.
During monitoring, important issues that are identified should be addressed as they are discovered, per the pre-established monitoring plan. In addition to directions for when and to whom important issues identified during monitoring should be escalated, a monitoring plan should also outline how they will be escalated.
The questions and answers provided in the guidance are intended to assist sponsors in planning and conducting risk-based approaches to monitoring.
To know the list of questions & answers click this LINK.
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