Drug Evaluation Committee 2017-79 Notification to medical institutions regarding the end of record retention period (Part 2)
Related classification: Record keeping
Date of first publication: March 2018
Question
This question is about the timing of issuing a report on discontinuation of development, etc.
When I was at a university hospital, I never received this report much later than the end of a clinical trial, but since moving to a general hospital, I am often told that this report has not been issued even though more than one year has passed since the end of the trial, and I am very troubled when it comes to preserving original materials because the retention period is undetermined. Is it difficult for us to find out when this report will be issued or what the alternative document preservation deadline is until the sponsor issues it?
In fact, we have been told that this report has not yet been issued, so we have been keeping it for a long period of time, but it has been so long that we have called to check on it, etc. There have been many trials where we have not been notified even though the retention period has expired. With limited storage space, we would like to ask for the cooperation of sponsors in preserving necessary documents.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The implementing medical institution is required to preserve records until the later of the following (1) or (2) (GCP Article 41, Paragraph 2, Guidance 1).
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(1)The date of approval for the manufacture and marketing of the drug for which the clinical trial is being conducted (in the case of notification of discontinuation of development, the date on which three years have elapsed since the date of notification).
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(2)Date when 3 years have elapsed since the discontinuation or termination of the clinical trial
Therefore, the sponsor is to inform the site of the record retention deadline not at the end of each study, but when the date of marketing approval or the date of decision to discontinue development of the study drug can be identified, which may be several years after the completion of the study, depending on the progress of development and the status of regulatory review. However, the timing may be several years after the completion of the clinical trial, depending on the progress of development and regulatory review. In addition to multiple clinical trials, various other studies are conducted in the development of pharmaceuticals, and the decision to discontinue development is made for a variety of reasons. Therefore, a decision to discontinue development may be made after a considerable period of time has elapsed since the completion of the clinical trial.
In addition, Article 4, Paragraph 1, Guidance 6 of the GCP states that the sponsor is required to notify the investigational sites and the investigational review committee of any records that should be preserved by the investigational sites and the investigational review committee when they are no longer required to be preserved. Therefore, the sponsor should promptly notify that retention is no longer required, but it may take some time due to the above reasons. When the sponsor does not notify the retention deadline and confirmation is required, it is acceptable to inquire with the relevant sponsor.
In addition, since the storage space for records is limited, it may be a good idea to consider how to handle records by referring to the "Partial Amendment to the Basic Policy on the Use of Electromagnetic Records in Clinical Trial Documents (July 1, 2014: Office Communication, Evaluation and Management Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare)" and other related documents.