Drug Evaluation Committee 2011-45 Documents or records that should be made available to the SMO upon direct inspection
Related classification: Other
First published: Apr. 2012
Revised publication date: December 2021
Question
Article 39-2 Guidance 9 of the GCP states that "The trustee shall comply with the provisions of Article 14, paragraph 6 of the Act and Article 80-2~ of the Act. The implementing medical institution shall make ~ documents or records (including data) to be kept by the trustee The Contracting Healthcare Organization shall clearly state in the contract for the clinical trial with the trustee that all records (including data) to be kept by the trustee are to be made available for direct inspection." The contract states that the contractor shall provide direct access to all documents and records (including data) to be kept by the trustee. If the trustee is an SMO, what exactly are the "documents or records (including data) to be kept by the trustee"? What exactly does "documents or records (including data) to be kept by the trustee" mean if the trustee is an SMO?
Currently, I think the contract related to the clinical trial would fall under this category, but other than that, I am not sure what else it clearly refers to.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The "documents or records to be kept by the trustee" stipulated in Article 39-2 Guidance 9 of the GCP are considered to be records related to the work entrusted by the medical institution. Documents or records to be created and handled in a clinical trial differ depending on the content and scope of the work entrusted by the implementing medical institution, so we cannot specify them in general. The contract should be clearly stated after discussion between the site and the SMO, taking into consideration whether the documents or records (originals) to be created and handled as entrusted work will be stored at the site or at the SMO. In addition, the August 31, 2020, Office Announcement, "Documents and Records Pertaining to Clinical Trials," added documents and records to be stored at the site support organization.
Reason for revision of opinion
In accordance with the revision of "Documents and Records Related to Clinical Trials" and the issuance of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Bureau, Japan, No. 0831-15), we have changed some of the statements in the Opinion.