Drug Evaluation Committee 2011-03 Retention Period for Original Medical Records
Related classification: Record keeping
Initial release date: 2011-07
Revised publication date: December 2021
Question
The retention period of medical records at our hospital has been changed from "permanent retention" to "20-year retention" (limited period). In the case of our hospital, clinical trial worksheets, etc. and regular medical information (paper medical records) are stored separately. Clinical trial worksheets and CRFs are, of course, strictly managed in the clinical trial office.
Since it is said that "the first document (or the original document for CRF transcription) is the source document," past paper charts with information such as the time of onset of the current disease should be treated as source documents, and the clinical trial office is obliged to keep paper charts that are more than 20 years old. We are concerned that paper medical records older than 20 years may have to be retained by the clinical trial office. Would we be in violation of the "obligation to retain source documents" if we do not locate the relevant past paper medical records for all clinical trials for which we currently have an "obligation to retain source documents" at our hospital?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stated in Article 24, Paragraph 2 of the Medical Practitioners Act, the retention period of medical records is 5 years, so I will answer based on the assumption that the 20-year retention is a regulation of your medical institution.
According to Article 41, Paragraph 2 of the GCP, source documents for clinical trials must be retained until the later of the following periods.
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(1) Date of approval of manufacturing and marketing of the drug for which the study drug is being tested
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The date on which three years have elapsed since the discontinuation or termination of the clinical trial
Furthermore, if the sponsor requires a longer retention period than the above, the site is to consult with the sponsor regarding the retention period and method (GCP Article 41, Paragraph 2, Guidance 1). Therefore, the retention period of source documents is stipulated in the contract for each clinical trial signed by the sponsor and the site. Therefore, medical records that serve as source documents for clinical trials must be retained for the period stipulated in the individual clinical trial agreement.
Article 2 Guidance 6 of GCP states that "source documents are documents, data and records (e.g., hospital records, medical records, ..., etc.) that serve as the basis for information on the factual course of the clinical trial, case reports, etc." The scope of source documents is to be confirmed by the investigator and secretariat to the sponsor (or monitor) prior to the start of the clinical trial ("monitoring"). However, the scope of records to be used as source documents is to be confirmed by the sponsor (or monitor) prior to the start of the clinical trial ("Sending of 'Standard Operating Guideline for Monitoring and Acceptance of Audit'," July 24, 2000, Pharmaceutical Affairs Council of Japan, No. 889). Therefore, if the medical record of 20 years ago regarding the current disease is decided as the source material, the medical record must be kept for the period stipulated in the contract for the clinical trial.
Even if the agreement with the sponsor requires long-term preservation of the source documents, it is not necessary to preserve all the medical records of the subject (for more than 20 years), since the records must be preserved for the part that is the source documents of the trial. If the sponsor has not notified you of the expiration of the retention period at the time of disposal, we recommend that you discuss with the sponsor whether or not to dispose of the medical records.
Reason for revision of opinion
The opinion text has been partially changed in accordance with the issuance of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15).