Drug Evaluation Committee 2020-17 Monitoring Methods for Clinical Trial Documents
Related classification: Other
Date of first publication: September 2020
Question
Please explain how to monitor clinical trial-related documents to be kept by investigators and investigational sites.
This concept applies not only to case monitoring but also to monitoring of documents to be preserved by investigators and institutions (so-called "essential documents"). Is it correct to interpret that this concept is applicable not only to case monitoring but also to monitoring of documents to be preserved by investigators and institutions (so-called mandatory document inspection), and that it is possible to select an appropriate monitoring method for mandatory document inspection as well? Also, is it possible to narrow down the procedures to be viewed on-site, as in the case of sampling SDV?
If quality assurance of the clinical trial can be properly performed at the site and other sites involved in the conduct of the clinical trial, it is not necessarily required that all clinical trial data, etc. be checked against the source documents."
Background of the question
We are reviewing our future monitoring methods, and we consulted with you because we have no experience in conducting mandatory document inspection other than on-site.
At the facility to which we belong, clinical trial procedural documents (request forms, change application forms, IRB notifications, etc.) are transferred through the system, and a system has been established to enable monitors to monitor the status of procedures off-site in a timely manner.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The MHLW notice "Basic Approach to Risk-Based Monitoring" mentioned in your question explains much about data monitoring, but we believe that this approach can also be applied to monitoring the status of documents and records related to clinical trials stored at the site.
Based on the "Basic Approach to Quality Management in Clinical Trials" (Notification of the Director, Drug Evaluation and Management Division, Pharmaceuticals and Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare, No. 0705-5, July 5, 2049), it would be good to determine, when planning monitoring, which points to focus on and which points to simplify based on the implementation system of the clinical trial. In this case, it would be good to determine which points to focus on during monitoring and which points can be simplified.
The strategies, methods, and rationale for the monitoring should be described in the monitoring plan in advance.