Drug Evaluation Committee 2010-38 Collective filing of records to be kept by investigators and the head of Investigator Site
Related classification: Record keeping
First published: Jan 2011
Revised publication date: March 2021
Question
Article 41, Paragraph 1, Guidance 2 of GCP states that "The investigator shall preserve documents and records related to the conduct of the clinical trial in accordance with the instructions of the head of the Investigator Site. Is there any problem with keeping documents and records after the completion of a clinical trial in a single file instead of separating them among the clinical trial office, investigator, and investigational drug administrator?
Also, as mentioned in question No. 2009-13, if the Clinical Research Office of an Investigator Site that has established an IRB also serves as the IRB office, there is no need to retain duplicate records. However, is it correct to think that there is no need 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 listed in the "Documents or Records Pertaining to Clinical Trials" list?
JPMA's Opinion
Article 41, Paragraph 1, Guidance 1 of the GCP stipulates that "The head of the Investigator Site shall designate a person responsible for record keeping for each record to be kept at the Investigator 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 "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, Office Communication) does not require the preservation of documents for each role, but lists the documents and records to be organized and rationalized and preserved by the Investigator Site. Therefore, we believe that there is no problem if the person in charge of record-keeping keeps the documents and records in an organized and streamlined manner in accordance with the instructions of the head of the Investigator Site.
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
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.