Drug Evaluation Committee 2009-37 Preservation of Older Drug Summaries at Contracting Medical Institutions
Related classification: Record keeping
First published: January 2010
Question
When a revised version of an investigational new drug summary is provided to a site, is it necessary for the site to retain the previous version?
Background/Reason
According to the "Documents and Records Pertaining to Clinical Trials" (October 2, 2007, NHI Drugs and Foods Review No. 1002002*), the medical institution is required to retain the "Investigational New Drug Summary (including the revised version)".
However, it is important to ensure that the latest version of the investigational new drug summary is always referred to at the site (to prevent accidental reference to the previous version), and in light of this, it is not necessarily necessary to retain the previous version. Can we interpret the above notice's reference to "investigational new drug summaries (including revised versions)" as "when an investigational new drug summary is revised, the revised version should be retained" and not as a requirement to retain all versions from the initial version?
We are aware of the need to keep a record indicating that the previous version was provided to the site and kept for the required period.
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As of December 2023(February 14, 2013, Ministry of Health, Labour and Welfare, Pharmaceutical and Food Safety Bureau, Evaluation and Management Division, Ministry of Health, Labour and Welfare)
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Regarding the investigational new drug summary submitted by the sponsor to the head of the implementing institution, all versions must be kept under the responsibility of the person in charge of record keeping (GCP Article 41). However, as stated in Article 41, Paragraph 1, Guidance 2 of GCP and Q&A of "Standard Operating Guideline for Acceptance of Monitoring and Audit" (Pharmaceutical Affairs Council, No. 889, July 24, 2000), if the site and sponsor determine that there is no need for duplicate retention by the person responsible for record keeping, investigator, investigational drug manager, etc., then the investigator and sponsor are required to retain the same version. If the sponsor determines that there is no need for duplicate storage, it is not necessary for the investigator, investigational drug manager, etc. to store all versions of the record. However, as mentioned in your question, I think it is necessary to be able to show in the record that the investigator, drug product manager, etc. received the previous version of the investigational new drug summary at that time.
GCP Article 41, Paragraph 1 Guidance 2
The investigator must preserve documents or records related to the conduct of the clinical trial in accordance with the instructions of the head of the investigational site.
Q&A for Standard Operating Guideline for Acceptance of Monitoring and Audit (Pharmaceutical Affairs Council No. 889, July 24, 2000)
- Q10
- Should all versions of materials and information provided by the sponsor be retained?
- A
- In principle, all the latest documents and information provided by the sponsor should be retained. However, it is necessary to confirm with the sponsor whether previous versions of materials and information received by the investigator, investigational drug manager, etc. should be retained.