Drug Evaluation Committee 2013-45 Scope of Monitoring - Documents to be kept by the SMO
Related classification: Other
Initial release date: December 2013
Revised publication date: December 2021
Question
The August 31, 2020, Office Communication, Attachment "List of Documents or Records Related to Clinical Trials" states that "Documents or records related to clinical trials are subject to investigation by regulatory authorities or audit by the sponsor or the person in charge of audit of the person conducting the clinical trial, and should be organized to be able to respond to such investigation or audit. It is necessary to organize them in such a way as to be able to respond to such investigations." However, there is no description from the viewpoint of who directly inspects which documents.
Please tell us if the documents "66. contract between the person who conducts the clinical trial or the site support organization and the site support organization" and "67. documents regarding the site support organization's procedures for compensation for health damage" which should be kept by the site support organization (SMO) are subject to direct inspection of required documents by monitors. The same document corresponding to 66, "29. Agreement between the person conducting the clinical trial or the site support organization and the site support organization," which is stored at the site, will be inspected.
I am aware that if it is properly stored in the SMO, there is no problem and it is not subject to direct inspection of required documents by monitors, but is it necessary for monitors to check the original?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
According to Article 39-2 Guidance 10 of the GCP, the contractor (SMO) shall, upon request of the audit staff of the site and the regulatory authority, directly inspect all documents or records (including data) to be kept. The Guidance does not stipulate that the sponsor shall have direct access to such documents and records.
Therefore, it is basically a matter for the site to confirm that these documents are properly stored in the SMO. The sponsor may inquire with the site as necessary about the status of storage of essential documents at the SMO, and depending on the status, the sponsor may check with the SMO.
Reason for revision of opinion
The opinion text has been partially changed in accordance with the issuance of the GCP Guidance (July 5, 2049, Pharmaceutical Affairs Council of Japan, No. 0705-3).