Drug Evaluation Committee 2017-66 Retention Period for Investigator Site Records in Post-Marketing Clinical Trials
Related classification: Record keeping
Date of first publication: February 2018
Question
Regarding the retention period of Investigator Site records 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 on which the reexamination or reevaluation is completed.
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 an Investigator Site that is not transferred?
- Investigator Sites that have not been contracted for post-marketing clinical trials shall retain the records until the later of the date of obtaining approval for manufacturing and marketing or the date three years have elapsed after the discontinuation or termination of the clinical trial.
- (3) Investigator Sites with which a post-marketing clinical study contract has been concluded shall retain the data until the date of completion of reexamination or reevaluation.
- All Investigator Sites that have been contracted to conduct clinical trials 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.
JPMA's Opinion
In a post-marketing clinical study used to apply for reexamination of a pharmaceutical product, documents or records pertaining to the study at the Investigator Site (hereinafter referred to as "relevant records") must be retained until the date when the reexamination or reevaluation of the product in question is completed (Article 11 of GPSP, Article 56 of GCP).
However, data at Investigator 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 such medical institutions until the later date of either the date of approval for manufacturing and marketing or the date three years have passed 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 an application for reexamination, 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.