Drug Evaluation Committee 2016-41 Submission of Notification Document Concerning Discontinuation of Development
Related classification: Record keeping
Date first published: December 2016
Question
In a certain clinical trial, a decision was made to "discontinue the clinical trial," a "Report on Discontinuation of Development, etc." (report item: discontinuation of the clinical trial in question) was submitted by the investigational site, and the sponsor submitted a notification of discontinuation of the clinical trial to the authorities. Several years later, the sponsor submitted a "Report on Discontinuation of Development" to the authority.
Question 1
In the above case, should the sponsor notify the site of the "Report on Discontinuation of Development, etc." (report item: discontinuation of development of the study drug) again?
Question 2
We would appreciate it if you could also tell us the purpose of notifying the site of "discontinuation of development". If the purpose of the notification is to clarify the retention period of the records, the purpose has been achieved with the submission of the initial report, and it is not necessary to submit a "Report on Discontinuation of Development, etc." (report item: discontinuation of development of the study drug) (if the sponsor does not need to change the retention period that was notified in the past). (When there is no need to change the retention period notified in the past as the sponsor). ICH-GCP also includes a statement to notify the site of "discontinuation of development," but is it correct to assume that the purpose is the same as in J-GCP?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Answer 1
Based on Article 24, Paragraph 3 of the GCP, it is necessary for the sponsor to notify the site in writing of the discontinuation of the development of the test product separately from the discontinuation of the clinical trial.
Answer 2
The record-keeping officer appointed by the head of the site must retain the records until the later of (1) or (2) below (GCP Article 41, Paragraph 2, Guidance 1).
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(1)The date of marketing authorization of the investigational drug concerned (in case of notification of discontinuation of development, three years from the date of notification)
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(2)The date on which three years have elapsed since the discontinuation or termination of the clinical trial
Even if a clinical trial is terminated, the period for which such records are required cannot be clearly defined because the records related to the clinical trial may be used to resume the clinical trial or as part of the materials at the time of application, but the above retention period is specified because the decision to terminate development may clarify the need for such records. It is considered that the above retention period is stipulated in order to clarify the need for the records. Therefore, it should be noted that the purpose of this provision is considered to be unfulfilled if the discontinuation of development is not notified after the notification of discontinuation of the clinical trial.
In addition, ICH-GCP 5.5.12 stipulates that it is the responsibility of the sponsor to notify the investigator and site in writing regarding record retention.