Drug Evaluation Committee 2010-57 External Preservation of Documents and Records Related to Clinical Trials
Related classification: Record keeping
Date of first publication: Apr. 2011
Question
The hospital (Clinical Trial Office) is supposed to store the documents and records attached to the "Report on Safety Information" among the documents and records related to the clinical trial in the investigator's custody, on behalf of the investigator. In that case, would it be possible to keep the documents while the clinical trial is in progress? Also, is there any difference in the handling of documents during and after the clinical trial?
Is it acceptable for the hospital, sponsor, and warehouse operator to enter into a three-party contract, with the sponsor bearing the costs (storage fees)? Or, if the sponsor stores the materials at the request of the hospital (investigator), is it acceptable for the sponsor to bear the costs (storage fees) in a three-party contract between the hospital, sponsor, and warehouse operator? Also, please tell us what documents can or cannot be stored in an external warehouse.
According to our hospital's rules for handling clinical trials (storage of records), "The investigator must keep the clinical trial protocol, source documents other than the medical record, consent documents, instructions, and other records related to the conduct of the clinical trial. The following documents or records (hereinafter referred to as "clinical trial documents or records") must be kept by the principal investigator.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Documents or records related to the clinical trial (hereinafter referred to as "records") must be stored appropriately in accordance with GCP and the contract with the sponsor, and the specific storage method must be in accordance with the procedure manual of the site.
When outsourcing the storage of records to be stored by the site to an external warehouse, a contract must be concluded between the site and the external warehouse operator in accordance with Article 39-2 of the GCP. In addition, these records must be made available for direct inspection promptly upon request of the sponsor, clinical trial review committee, or regulatory authorities. Furthermore, we believe that during a clinical trial, records should be stored within the site unless the investigators, etc. have access to necessary information at any time.
Article 41, Paragraph 1 of the GCP stipulates that "the head of the site must appoint a person in charge of record keeping. The guidance in Paragraph 2 of the same article stipulates that "the person in charge of record keeping shall preserve documents or records that should be preserved at the site. Therefore, it is problematic for the sponsor to shoulder the investigator's record-keeping responsibility.
Considering the above points, we do not see a problem with outsourcing record keeping to an external warehouse. As for the cost burden when outsourcing to an external warehouse, the sponsor may have a different view, so we refrain from expressing our opinion as a pharmaceutical association.
Please also refer to Question No. 2004-10, "External Storage of Medical Records.