Drug Evaluation Committee 2017-66 Retention period for records of medical institutions in post-marketing clinical trials
Related classification: Record keeping
Date of first publication: February 2018
Question
Regarding the retention period of records of medical institutions in post-marketing clinical trials, Article 56 of the GCP states, as a replacement of Article 41, Paragraph 2, "The records shall be retained until the date of completion of reexamination or reevaluation.
Which of the following is the appropriate retention period for a study that is transferred from a clinical trial to a post-marketing clinical study after obtaining manufacturing and marketing approval, when there is a medical institution that is not transferred?
- The medical institution with which no post-marketing clinical trial agreement has been concluded should retain the clinical trial agreement until the later date of either the date of obtaining approval for manufacturing and marketing or the date three years have passed after the discontinuation or termination of the clinical trial.
- (2) The medical institution with which a contract for post-marketing clinical trials has been concluded shall retain the data until the date of completion of reexamination or reevaluation.
- All medical institutions that have been contracted to conduct a clinical trial in a unified manner as a clinical trial, regardless of the contract for post-marketing clinical trials, shall retain the data until the date when the reexamination or reevaluation is completed.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In a post-marketing clinical study used to apply for reexamination of a pharmaceutical product, documents or records pertaining to the study (hereinafter referred to as "relevant records") at the site must be retained until the date of completion of reexamination or reevaluation of the product in question (Article 11 of GPSP, Article 56 of GCP).
However, data at investigational sites that have not been transferred to post-marketing clinical trials are compiled as clinical trial results and a summary report is prepared. Therefore, it is acceptable to keep the relevant records at the relevant medical institution until the later date of either the date of marketing approval or three years after the discontinuation or termination of the clinical trial (GCP Article 41, Paragraph 2).
However, when data from the relevant medical institution is also used in the reexamination application, we believe that the relevant records should be retained until the date of completion of the reexamination or reevaluation. In such cases, we recommend that the retention period of the clinical trial agreement concluded with the relevant medical institution be confirmed and a memorandum extending the period be concluded as necessary.