Drug Evaluation Committee 2008-22 Scope of required records of deviations from the clinical trial protocol (Part 2)
Related classification: Other
Date of first publication: 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 subjects 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 danger to subjects" (GCP Article 46, Operational Notification 6), The investigator is required to report the deviation/change in writing to the sponsor and the head of the Investigator 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?
JPMA's Opinion
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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 to do so. However, there may be cases where the protocol stipulates the submission of such deviation report, etc. Therefore, it is necessary to discuss the handling of clinical trials underway as of October 1, 2008, between the sponsor and Investigator 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 the deviation report, it is important to clarify the division of roles between the Investigator Site and the sponsor. That is, the Investigator 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 sponsor and take action.