Drug Evaluation Committee 2019-12 Changes to record retention periods during the conduct of a clinical trial
Related classification: Record keeping
Date of first publication: 2019-06
Question
In our model clinical trial agreement, the retention period for "Documents or records pertaining to the clinical trial" is the number of years required by J-GCP. In addition, it states that "changes to the retention period, etc., may be determined through consultation between the site and sponsor. In the case of an international joint clinical trial that requires a contract with a retention period as required by ICH-GCP from the start of the clinical trial, the contract is concluded after including the retention period in the contract beforehand. If the retention period is changed during the clinical trial, a "Report on Discontinuation of Development, etc." will be submitted to the site in the future, as shown in the notes of our contract (model), is it possible to operate without making any special changes to the contract (memorandum of understanding, etc.) as long as the site has consented? Is this possible?
Opinion of the Pharmaceutical Cooperative Association
Article 13, Paragraph 1, Guidance 3 (9) of the GCP stipulates that the site shall retain the documents or records to be retained until the sponsor notifies the site that such retention is no longer necessary, and also stipulates that the site shall not retain the documents or records that the sponsor requires for a longer period than stipulated in Article 41 and Article 34 of the GCP. In addition, if the sponsor requires a longer retention period than that stipulated in Articles 41 and 34 of the GCP, the sponsor is to be consulted.
However, some sponsors may consider it necessary to specify the new retention period in the clinical trial agreement (i.e., sign a memorandum of understanding) in order to clarify the retention period, so it would be better to discuss the matter with the sponsor and the site. Therefore, it is recommended that the sponsor and the site should discuss and decide how to respond to this issue.
The ICH-GCP stipulates that the retention period of records "shall be in accordance with the regulatory requirements of each country. Therefore, we believe that the case in question is a response based on the regulatory requirements of other countries.