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 the Clinical Trial Review Committee records on its website (contents include deliberations, whether they were approved or not, names of participating committee members, date and time of the meeting, etc.). Monitors are able to view the paper version of what is posted on the website 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.
JPMA's Opinion
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, the Investigator Site must present the originals when the monitor inspects the records or documents in person, so the Investigator Committee's review of the summary of records must be performed on the originals.