Drug Evaluation Committee 2020-16 Preservation of Documents and Records to be Preserved at Investigator 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 electronic ISF (Investigator Site File) to be "an electronic ISF for documents created by the sponsor" during the clinical trial period, and uploading = storage of ISF (no further storage is required), and the sponsor has told us to save the documents to be provided to the Investigator Site on CD-Rs, etc. after the trial is completed. However, the data is not stored at the Investigator Site in this way. Is it considered to be stored at the Investigator 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 in both the Investigator Site's cloud (in use at our hospital) and the sponsor's cloud, but as long as we can access the cloud, does it not matter which cloud is managed?
JPMA's Opinion
According to Article 41, Paragraph 1, Guidance 1 of the GCP, "The head of the Investigator Site shall, when storing records (including documents) that are to be stored at the Investigator Site, keep a record of each of the following. The guidance in Article 41, Paragraph 1, Guidance 1 of the GCP states, "The head of the implementing medical institution shall appoint 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 Investigator Site shall retain the authority to manage all documents and records related to the clinical trial created by the investigator and the Investigator Site 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 Investigator Site (or the person in charge of record keeping at the Investigator 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 or other 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 contact states that, in the case where cloud computing is utilized, "it is expected that 'delivery through cloud computing systems' and 'storage through cloud computing systems' can be conducted using the same server by the party delivering and the party receiving the documents. 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 Investigator 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 a 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, they are considered to be "stored" in the Investigator Site. However, please check with the sponsor for details on how to respond to the requirements.