Drug Evaluation Committee 2013-05 Provision of Annexes/Annexes to Clinical Trial Protocols to Investigator Sites, etc.
Related classification: Record keeping
Initial release date: July 2013
Revised release date: December 2021
Question
In relation to previous question 2012-24 (Preservation of Annexes/Branches of the Clinical Trial Protocol) in Clinical Trial 119, please explain the handling of Annexes to the Clinical Trial Protocol (documents that consolidate information from all Investigator Sites).
If any of the following revisions occur in the Appendix of the study protocol, do we need to provide the revised version of the Appendix to the heads of all Investigator Sites and investigators?
Revisions to 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)
We are of the opinion that some changes in the sponsor's implementation system are common to all Investigator Sites and therefore need to be provided to all heads of Investigator Sites and investigators, while others believe 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.
JPMA's Opinion
It is acceptable to provide only the revised version of the annexes (the "annexes" in GCP) due to changes in monitors to the heads of Investigator Sites and investigators in accordance with Guidance 2 of Article 7, Paragraph 1 and Guidance 6 of Paragraph 4/5 of Article 7, Paragraph 1 of GCP. In cases where, instead of listing the names and telephone numbers of individual monitors, those of their representatives are listed on a separate sheet, the revised version of the separate sheet due to a change in the representative must be provided to the heads of all Investigator 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 the change in the relevant items to the heads of all Investigator Sites and the investigators. If the sponsor believes that the information is information that should be communicated to all heads of Investigator Sites and investigators, then the revised version of the Appendix should also be provided to all heads of Investigator Sites and investigators.
Reason for revision
We have partially changed the opinion text in accordance with the issuance of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15).