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, we agreed with the sponsor not to conclude a clinical trial agreement because all of the potential subjects did not meet the selection criteria. If a clinical trial agreement is not concluded, does the Investigator Site have an obligation to keep the documents kept by the head of the Investigator Site and the 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.
JPMA's Opinion
The record retention period by the Investigator Site stipulated in Article 41, Paragraph 2 of the GCP applies when the sponsor requests the Investigator 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 Investigator Site is not obligated to retain the records under GCP.