Drug Evaluation Committee 2017-23 Definition of "Discontinuation date/end date of clinical trial"
Related classification: Record keeping
Date of first publication: October 2017
Question
Background
Regarding the retention period of records at the site, Article 41, Paragraph 2 of the GCP stipulates "the period until the later of the date of approval for marketing (when notification is received pursuant to Article 24, Paragraph 3 or Article 26-10, Paragraph 3, the date three years have passed since the date of notification) or the date three years have passed since the discontinuation or termination of the clinical trial. (2) "until the later of the date of discontinuation or termination of the clinical trial".
Question
What date does this "discontinuation or termination of a clinical trial" refer to?
- 1.Date of "discontinuation or termination of clinical trial" notification or report for each site
- 2.Date of "discontinuation or termination" notification by the sponsor
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Since a clinical trial is conducted for the purpose of applying for manufacturing and marketing approval of a drug, we believe that the retention period of materials collected and prepared in a clinical trial should be the same for each clinical trial, not different for each investigational site.
Since there is no provision in GCP regarding the date of "discontinuation or termination of a clinical trial," we think there is no problem in setting a date that the sponsor considers appropriate, such as the "date of notification of 'discontinuation or termination of a clinical trial' by the sponsor," as you mentioned in your question.