Drug Evaluation Committee 2018-37 Preservation and accessibility of relevant documents when an external Clinical Trial Review Committee review is requested
Related classification: Record keeping
Date of first publication: January 2019
Question
The hospital requests a review by the Clinical Trial Review Committee established by the same group (located in a different district).
1. documents to be preserved
Upon completion of the review by the Clinical Trial Review Committee, a copy of the agenda, minutes, and summary of the meeting are sent to our hospital from the committee. In addition, the agenda and results of the review will be sent to you by e-mail. Is it mandatory to keep a copy of all the documents?
2. inspection by the sponsor of a clinical trial of documents related to the Clinical Trial Review Committee
Our hospital has requested the person in charge of the committee to allow us to inspect the documents of the Clinical Trial Review Committee. If the sponsor (monitor) wishes to inspect a copy of the above documents stored at our hospital, is it necessary to present that copy?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If the head of a medical institution requests a review by a clinical trial review committee established by another medical institution (general incorporated association, specified nonprofit corporation, school corporation that owns the medical institution, etc.), the documents to be preserved by the medical institution are the standard operating procedures of the clinical trial review committee, the list of committee members (GCP Article 30, Paragraph 8) and the opinions from the clinical trial review committee (GCP Article 30, Paragraph 9). The documents to be kept by the institution are the standard operating procedures of the clinical trial review committee, the list of committee members (GCP Article 30, Paragraph 8), and the opinion from the clinical trial review committee (so-called "notification of clinical trial review results" (GCP Article 32, Paragraphs 1 and 3).
Therefore, it is not mandatory for the site to keep a copy of the proceedings, minutes and summary of the proceedings. However, if these documents are kept as clinical trial-related records, they must be made available for direct inspection in accordance with Article 37 of the GCP.