Drug Evaluation Committee 2016-21 How to Review Summary of Clinical Trial Review Committee Records
Related classification: Clinical Trial Review Committee
Date of first publication: August 2016
Question
The hospital posts a summary of Clinical Trial Review Committee records on its website (contents include deliberations, whether they were approved or not, names of participating committee members, and the date and time of the meeting). Monitors are given paper copies of what is posted on the website to view when viewing the required documents. In this case, is there a problem if we ask them to check the summary of the clinical trial review committee records on the website and eliminate the paper version for viewing? If there is a need to view information that is not posted on the website, paper copies are available for viewing.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If the purpose is to confirm that the "summary of the record of the meeting" of the Clinical Trial Review Committee is appropriately published on the website, there is no problem with the monitor viewing the website itself.
However, when the monitor inspects the records or documents in person, the site must present the original documents, so confirmation of the summary of the Trial Review Committee meeting record must be made on the original documents.