Drug Evaluation Committee 2011-48 Preservation of Records Related to Contract Testing by Medical Institutions
Related classification: Other
First published: Apr. 2012
Revised publication date: December 2021
Question
In a clinical trial at a nearby clinic, we received a request for outsourcing of some tests that cannot be performed at the clinic (MRI in this case) and nighttime/emergency response services. When we drafted the outsourcing agreement, we found that Article 39-2 of the GCP requires our clinic, which is entrusted with the work, to accept investigations by the regulatory authority and to keep documents and records related to the clinical trial, and the agreement also clearly states this.
However, I believe that the investigation will be completed within the investigative site, as the results of the commissioned tests and medical information during emergency response are reported to the investigative site through the normal process of providing medical information, based on the request of the investigative site. Therefore, I was wondering whether our hospital is also subject to investigation by the regulatory authorities and whether we have to accept it, or whether we have to keep information related to the clinical trial at our hospital in accordance with GCP rather than the Medical Practitioners Act.
I would appreciate the Pharmaceutical Manufacturers Association's (PMA) opinion on what the intent of this revision was and whether we still have to respond in accordance with the GCP.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
When outsourcing part of the work related to the conduct of a clinical trial, the site must conclude a contract with the party entrusted with such work in accordance with Article 39-2 of the GCP. Furthermore, as stipulated in Article 9 of the same guidance, "The contractor shall be subject to investigation, etc. pursuant to the provisions of the second sentence of Article 14, Paragraph 6 of the Act and Article 80-2, Paragraph 7 of the Act. as well as, "The implementing medical institution shall clearly state in the clinical trial agreement with the trustee that all documents or records (including data) to be kept by the trustee at the time of the investigation by the regulatory authority shall be made available for direct inspection." It is necessary to
If the inspections that your hospital is contracted to perform are inspections that are performed as part of the conduct of the clinical trial (i.e., inspections stipulated in the protocol), you must conclude an agreement that includes each item stipulated in the same article, and you must accept an investigation by the regulatory authority if requested. In addition, if the trustee retains documents to be retained, such as source documents, after the completion of the clinical trial, the documents to be retained and the retention period must be stated in the relevant contract.
Regarding the acceptance of nighttime and emergency response (support for "taking necessary measures for subjects in an emergency" as stipulated in Article 35 of the GCP), it is desirable to conclude a contract between the medical institution that accepts emergency response and the implementing medical institution, but this does not fall under a contract based on Article 39-2. However, it is not considered to be a contract under Article 39-2.
Reason for revision of opinion
The referenced clause has been changed in accordance with the issuance of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15).