Drug Evaluation Committee 2013-45 Scope of Monitoring - Documents to be kept by the SMO
Related classification: Other
Initial release date: December 2013
Revised release date: December 2021
Question
In the Attachment "List of Documents or Records Related to Clinical Trials" of the August 31, 2020 Communication, it is stated that "Documents or records related to clinical trials may be subject to investigation by regulatory authorities or audits by the sponsor or the person in charge of the audit of the person conducting the clinical trial, and should be organized to be able to respond to such investigations. 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. Agreement between the site site support organization and the Investigator Site or the site support organization who conducts the clinical trial on its own" and "67. The same document "29. Agreement between the person who conducts the clinical trial or the Investigator Site and the site support organization" corresponding to "66" 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?
JPMA's Opinion
According to Article 39-2 Guidance 10 of the GCP, the contractor (SMO) shall, upon request of the Investigator Site's auditor and regulatory authorities, directly inspect all documents or records (including data) that should be preserved. 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 Investigator Site to confirm that these documents are properly stored in the SMO. The sponsor may inquire with the Investigator Site about the storage status of essential documents at the SMO as necessary, and depending on the status, the sponsor may check with the SMO.
Reason for revision
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).