Drug Evaluation Committee 2010-38 Bulk filing of records to be kept by the investigator and the head of the investigational site
Related classification: Record keeping
First published: Jan 2011
Revised release date: Mar. 2021
Question
GCP Article 41, Paragraph 1, Guidance 2 states "The investigator shall preserve documents or records related to the conduct of the clinical trial in accordance with the instructions of the head of the implementing medical institution. Is there any problem with keeping documents and records after the completion of a clinical trial in one place instead of dividing them among the clinical trial office, investigator, and investigational drug administrator?
Also, as mentioned in question No. 2009-13, if the clinical trial office of a medical institution that has established an IRB also serves as the IRB secretariat, there is no need to store duplicate records. However, is it correct to think that it is not necessary to retain copies of documents between the hospital director and the investigator (including documents to which the sponsor is the addressee or submitter) other than those in the list of "Documents or Records Pertaining to Clinical Trials" (copies as a copy for submission or for confirmation of contents (such as a copy for confirmation of contents of the investigator's clinical trial agreement))?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 41, Paragraph 1, Guidance 1 of the GCP stipulates that "The head of the site must designate a person responsible for record keeping for each record to be kept at the site. The Guidance 1 of Article 41, Paragraph 1 of the GCP stipulates that "the head of the implementing medical institution shall designate a person in charge of record keeping for each record to be kept at the implementing medical institution. In addition, the "Regarding Documents and Records Pertaining to Clinical Trials" (August 31, 2020, Ministry of Health, Labour and Welfare, Pharmaceuticals and Welfare Bureau, Drug Evaluation and Control Division, Administrative Communication) does not require the preservation of documents by role as in your question, but rather provides a list of documents and records to be organized and rationalized and preserved by the site of conducting medical institution. Therefore, we believe that there is no problem if the person in charge of record-keeping organizes and rationalizes the documents and records and stores them in accordance with the instructions of the head of the implementing medical institution.
The documents and records listed in the "Documents and Records Pertaining to Clinical Trials" are examples, as explained in the above notice, and documents and records that can confirm the process of conducting clinical trials must be preserved. One of the documents in your question is listed as "a copy for the investigator to confirm the contents of the clinical trial agreement," but this is a document that falls under Article 13, Paragraph 1, Guidance 1 of the GCP, which states, "The investigator shall confirm the contents of the agreement, but is not necessarily required to sign or otherwise sign it. (In other words, the investigator does not sign the copy), then there is no need to keep the document.
The meaning of preserving documents and records is that they can be used as evidence to explain to a third party that the clinical trial was conducted in an ethical and scientific manner. This is the reason for preserving documents and records. If documents and records generated in various procedures are filed in a timely manner, we believe that they can be explained to a third party in their original form. It is recommended that an efficient storage method be considered so that there is no need to "re-store copies of documents" after the completion of a clinical trial.
Reason for revision of opinion
In accordance with the issuance of "Documents and Records Pertaining to Clinical Trials" (August 31, 2020, Ministry of Health, Labour and Welfare, Pharmaceuticals and Welfare Bureau, Drug Evaluation and Control Division), minor changes were made to the description.