Drug Evaluation Committee 2008-22 Scope of required records of deviations from the clinical trial protocol (Part 2)
Related classification: Other
First published: January 2009
Question
Please explain the following points regarding the GCP operation notice issued on October 1, 2008 (Pharmaceutical and Food Safety Commission of Japan, No. 100001).
In the event of "deviation from the study protocol to avoid immediate danger to the subject or for other unavoidable medical reasons" (GCP Article 46, Operational Notification 2) and "any change in the study that may significantly affect the conduct of the study or increase the risk to the subject" (GCP Article 46, Operational Notification 6), The investigator is required to report such deviations/changes in writing to the sponsor and the head of the investigational site.
- 1.Who determines whether or not the above deviation/change is applicable?
- 2.How should we respond to a request from the sponsor to submit a report on a minor deviation that does not fall under the above deviation/alteration?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
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1.We believe that medical judgment can only be made by the physician examining the subject concerned. Therefore, we believe that it is the investigator or sub-investigator who should make the decision.
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2.Basically, since this is not required by GCP, it is acceptable to refuse. However, there may be cases where the protocol stipulates the submission of such a deviation report, etc. Therefore, it is necessary to discuss how to handle clinical trials that are being conducted as of October 1, 2008, with the sponsor and the site. Therefore, it is necessary to discuss the handling of clinical trials in progress as of October 1, 2008 between the sponsor and the site. In the abolishment of such deviation reports, it is important to clarify the division of roles between the sponsor and the investigational site. That is, the site should be aware of the deviation and work to prevent recurrence, and the monitor should confirm whether measures are being taken to prevent recurrence, and if not, alert the site and take action.