Drug Evaluation Committee 2018-36 Agreement by Responsible Clinical Investigators to the Revised Clinical Trial Protocol
Related classification: Other
Initial release date: December 2018
Revised publication date: December 2021
Question
In an ongoing clinical trial, the study protocol was revised (2nd edition) and further revised (3rd edition) two weeks later.
In my experience, in all of the above cases, the investigator's agreement was obtained in writing for all study protocols. However, this time, due to the short period of time required for the revision, we decided not to obtain agreement on the second version with the site and to obtain agreement in writing only on the third version. We decided to follow this policy due to the timing of appointments with the investigators.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
When the protocol is revised, the investigator and the person requesting the clinical trial must each sign and date the protocol or a replacement document to certify that they have reviewed and agreed to comply with the revised protocol (GCP Article 7, Paragraph 4/5 Guidance 5). (GCP Article 7, Paragraph 4/5, Guidance 5).
Therefore, basically, the investigator is required to sign and date both the second and third versions of the protocol.
On the other hand, if the third version was revised before the second version was discussed by the IRB, it would be possible to skip the second version and agree with the investigator on the third version. However, even in such a case, it is necessary to provide the 2nd edition and explain its revised contents to the investigators and obtain their agreement on the 3rd edition. It is important for medical institutions to maintain records that enable them to confirm the revision process of the clinical trial protocol.
Reason for revision of opinion
With the issuance of the GCP Guidance (July 30, 2021, Pharmaceutical Affairs Bureau of Japan, No. 0705-3), minor changes were made to the GCP Guidance.