Drug Evaluation Committee 2020-16 Preservation of Documents and Records Stored at the Clinical Trial Site Using the System Provided by the Sponsor
Related classification: Record keeping
Initial release date: Jul. 2020
Question
The study protocol, investigational new drug summary, various manuals, sponsor-issued letters, etc. are delivered to investigators/CRCs via a web portal provided by the sponsor, and records of receipt (including the study protocol agreement) are also taken there.
The sponsor considers the ISF to be an "electronic ISF (Investigator Site File) for documents prepared by the sponsor" during the clinical trial period, and uploading the ISF = preservation of the ISF (no further preservation is required), and we are told to save the documents to be provided to the site on CD-Rs, etc. after the trial is completed. However, the data is not stored at the site in this way. Is it considered to be stored at the site because it is accessible? Also, is it acceptable if we create a document such as an agreement with the sponsor?
Storage using the cloud is increasing. We are aware that we need to store the data both in the cloud at the site (in use at our hospital) and in the cloud at the sponsor's site, but as long as it is accessible, does it not matter which cloud is managed by which site?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
According to Article 41, Paragraph 1, Guidance 1 of the GCP, "The head of the implementing medical institution shall, when storing records (including documents) that should be stored at the implementing medical institution, store each record in a separate cloud. The guidance in Article 41, Paragraph 1, Guidance 1 of the GCP states, "The head of the implementing medical institution shall designate a person responsible for record keeping for each record to be kept at the implementing medical institution (including documents). Article 41, Paragraph 1, Guidance 3 of the same article states, "The investigator and the head of the implementing medical institution shall retain the authority to manage all documents and records related to the clinical trial created by the investigator and the implementing medical institution before, during, and after the start of the clinical trial. The "Authority to manage all documents and records pertaining to the clinical trial" is stated in the regulation. In addition, the Appendix "List of Documents or Records Pertaining to Clinical Trials" of "Documents or Records Pertaining to Clinical Trials (July 5, 2027: Office Communication, Drug Evaluation and Management Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare)" states that "Personnel involved in clinical trials shall maintain records regarding the location of each document or record including original materials. storage system (regardless of the medium used) during and after the conduct of the clinical trial. should have capabilities for document identification, update history, search and retrieval." The "Requirements for the Retention of Documents" (Article 3.2.1) states Therefore, as long as the investigator and the head of the site (or the person in charge of record keeping at the site) clarify the location of documents pertaining to the clinical trial and retain the authority to manage the storage system, it is possible to use a secure cloud system as the storage location.
Regarding the use of cloud computing systems, the "Methods and considerations for storing clinical trial-related documents as electromagnetic records" are described in Attachment 3.(2)(2)ⅲ) of the "Partial revision of the basic idea regarding the use of electromagnetic records in clinical trial-related documents" (July 1, 2014: Office Communication, Evaluation and Management Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare). It also states that "it is possible to continue outsourcing such storage operations after the completion of a clinical trial, or to continue outsourcing storage operations after separately recording the relevant electromagnetic records on DVD-Rs, etc." as a method and points to note when storing clinical trial-related documents as electromagnetic records. The same is true for the case of the "outsourcing of preservation operations".
Furthermore, Attachment 4.(4) of the same circular states that, in the event that cloud computing is utilized, "it is expected that 'delivery through a cloud computing system' and 'storage through a cloud computing system' can be conducted using the same server on both the delivering and receiving sides" and that, in such a case, "the same server can be used for both the delivering side and the receiving side". In such cases, it is important to establish an environment in which it is clear that "the relevant matters are recorded in a file on the computer used by the other party. For example, it is stated that "it should be stipulated in the procedure manual, etc., in advance that logs, etc., can be used to verify the factual process, and that during the retention period stipulated by law, the electromagnetic record can always be checked at the will of the receiving party and a document can be created through file output. Regarding the method of preservation of documents and records to be stored at the investigational site, if preservation using the Web portal provided by the sponsor as in your question, or transfer and preservation to CD-R, etc. after the completion of the clinical trial are made as records related to whereabouts, and if they meet the requirements required by related laws, regulations, notices, etc. concerning computerization of clinical trial-related documents including the above-mentioned administrative communication, then there is no problem. However, please check with the sponsor for details on how to respond to the requirements.