Drug Evaluation Committee 2016-62 Retention period for records related to clinical trials that did not result in a contract
Related classification: Record keeping
Date of first publication: June 2017
Question
After approval by the Clinical Trial Review Committee, it was agreed with the sponsor that no contract would be concluded because all potential subjects did not meet the selection criteria. If a clinical trial contract is not concluded, does the site have an obligation to keep the documents kept by the head of the site and the principal investigator, including the procedure manual, etc.? Since we have not received any communication from the sponsor, we think it is acceptable to keep the documents for 3 years in accordance with the domestic GCP. The clinical trial subject is an international joint clinical trial.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The record retention period by the site as stipulated in Article 41, Paragraph 2 of the GCP applies when the sponsor requests the site to conduct the clinical trial. In the case of your question, since the clinical trial is not actually conducted and no contract has been concluded with the sponsor, the medical institution is not obliged to keep the records under GCP.