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 Investigator Site, etc. will likely be listed on a separate sheet, not in the main body of the clinical trial protocol. In some cases, the name of the relevant Investigator Site may not be listed on the Appendix at the time of the initial review by the Investigator Site's Clinical Trial Review Committee.
- Is there any problem with this case under GCP?
- Is there any timing when the Investigator Site must be approved by the Investigational Review Committee? For example, the annex must be approved at the time of delivery of the investigational drug....
JPMA's Opinion
When revising 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 Investigator Site Chairperson, and the Investigator Site Chairperson must submit the revised version to the Clinical Trial Review Committee. When requesting a clinical trial, including the addition of an Investigator Site, the investigator and the sponsor agree on the protocol, including the contents of the Appendix, and therefore, the sponsor will usually attach the revised version with the name of the relevant Investigator Site, etc. to the clinical trial request.
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 Appendix of the protocol is a document that includes the name of the Investigator Site, the name of the investigator, the name of the monitor, etc., and is not considered to contain important information that should be reviewed by the Trial Review Committee, so the content of the Appendix 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 such a case, it is necessary to submit a separate sheet of paper containing the name of the Investigator Site to the Trial Review Committee at a later date in accordance with the aforementioned procedures.