Drug Evaluation Committee 2013-05 Provision of Annexes/Annexes to Clinical Trial Protocols for Investigational New Drugs to Medical Institutions
Related classification: Record keeping
Initial release date: July 2013
Revised release date: December 2021
Question
In relation to previous question 2012-24 (Preservation of Appendixes/Branches of Clinical Trial Protocols) in Clinical Trial 119, please tell us about the handling of the Appendixes (documents that consolidate information from all sites) of the Clinical Trial Protocols.
If any of the following revisions occur in the Appendix of the protocol, do we need to provide the revised version of the Appendix to the heads of all investigational sites and investigators?
Revised Contents of the Appendix of the Clinical Trial Protocol
- Change of the person in charge of conducting the clinical trial at the sponsor (from Mr. A to Mr. B)
- Change of the person in charge of conducting the clinical trial at the sponsor (Mr. C ⇒ Mr. D)
- Change of the person in charge of monitoring (Mr. E ⇒ Mr. F)
There are two opinions in our company, one is that it is necessary to provide the revised version to all site directors and investigators because the changes in the sponsor's implementation system are common to all sites, and the other is that it is not necessary.
Based on the interpretation of GCP Article 32, Paragraph 1, GCP Article 31, Paragraph 1, Paragraph 2, Guidance 3, and GCP Article 7, Paragraph 1, please explain your opinion on the above case again this time.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
It is acceptable to provide only the revised version of the annexes (the "annexes" in GCP) due to a change in monitors to the head of the site and the investigator in accordance with Article 7, Paragraph 1, Guidance 2 and Article 7, Paragraph 4/5, Guidance 6 of the GCP. In addition, if instead of listing the names and telephone numbers of individual monitors, those of their representatives are listed on a separate sheet, a revised version of the separate sheet due to a change in the representative must be provided to the heads of all sites and the investigators.
On the other hand, GCP does not stipulate that the implementation system of the sponsor other than the monitors (or their representatives) should be described, so it is up to the sponsor to decide whether or not to provide a revised version of the annex for such changes to the heads of all sites and responsible investigators. If the sponsor believes that the information should be communicated to all site directors and investigators, then the revised version of the Appendix should also be provided to all site directors and investigators.
Reason for revision of opinion
The opinion has been partially changed in accordance with the issuance of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15).