Drug Evaluation Committee 2017-20 Necessity of Approval of the Clinical Trial Protocol Appendix by the Clinical Trial Review Committee
Related classification: Clinical Trial Review Committee
Date of first publication: October 2017
Question
The name of the site and other information are often included in a separate sheet of the protocol, rather than in the main body of the protocol. The name of the relevant site may not be listed on the Appendix at the time of the initial review by the Clinical Trial Review Committee for the relevant site.
- Is there any problem with this case under GCP?
- Is there any particular timing when the annex containing the name of the investigational site must be approved by the Clinical Trial Review Committee? For example, the annex must be approved at the time the investigational new drug is delivered...
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If the sponsor wishes to revise information in the Appendix (annex) of the protocol that is specific to the site, the sponsor must submit the revised version to the investigator and the head of the site, and the head of the site must submit the revised version to the Clinical Trial Review Committee. When requesting a clinical trial, including the addition of an additional site, the investigator and the sponsor agree on the protocol, including the contents of the attached sheet, so the sponsor will usually attach the revised version with the name of the site, etc., and request the clinical trial.
On the other hand, the investigational review committee examines the protocol and other documents to determine whether the trial is ethically and scientifically appropriate before starting the trial (GCP Article 32, Paragraph 1). The annex to the protocol is a document that includes the name of the medical institution, the name of the investigator, the name of the monitor, etc., and is not considered to contain any important information that should be reviewed by the Trial Review Committee, so the content of the annex itself is not necessarily subject to review. Therefore, it is not a problem even if the name of the relevant medical institution is not included in the Appendix at the time of the initial review. In this case, it is necessary to submit a separate sheet to the Clinical Trial Review Committee at a later date that includes the name of the relevant medical institution, etc., in accordance with the aforementioned procedures.