Drug Evaluation Committee 2004-10 External storage of medical records
Related classification: Record keeping
First published: December 2004
Revised publication date: April 2013
Question
In GCP, there is a description of medical records and other records, but there is no description of where they are stored. Do medical records have to be kept in the hospital? Is it acceptable under GCP to store medical records in an appropriate location outside the facility, and to transmit them by telegraph or other means when necessary?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Regarding the storage location of medical records, "Regarding the storage location of medical records" (Medical Affairs Bureau Director and Insurance Bureau Director Notification No. 0329003 and No. 0329001 dated March 29, 2002) states that medical records can be stored in locations other than the hospital or clinic where they were created and the standards that must be followed in such cases. The standards to be complied with in such cases are also indicated. In addition to this notice, there are other standards that we have researched:
- Partial revision of "Where to store medical records, etc." (March 25, 2013, Medical Affairs Bureau Director-General of the Ministry of Health, Labour and Welfare, Director-General of the Pharmaceutical and Food Safety Bureau of the Ministry of Health, Labour and Welfare, Director-General of the Insurance Bureau of the Ministry of Health, Labour and Welfare, and Director-General of the Health Insurance Bureau of the Ministry of Health, Labour and Welfare)
- Guidelines for the external storage of medical records, etc. (May 31, 2002, Medical Affairs Bureau No. 0531005)
- Enforcement of the Act on the Use of Information and Communications Technology for the Preservation of Documents by Private Businesses, etc. (Medical Affairs Bureau Director-General, Ministry of Health, Labour and Welfare, Pharmaceutical and Food Safety Bureau Director-General, Ministry of Health, Labour and Welfare, and Health Insurance Bureau Director-General Notification, March 31, 2005, Medical Affairs Bureau Director-General, Ministry of Health, Labour and Welfare, Pharmaceutical and Food Safety Bureau Director-General, Ministry of Health, Labour and Welfare), and The revised version of the "Guidelines for the Safety Management of Medical Information Systems" to which this notice refers.
- (August 13, 2002, Pharmaceutical Affairs Bureau Director-General's Notice No. 0813001, Ministry of Health, Labour and Welfare, regarding the preservation of records and ledgers by electronic media)
The above-mentioned notifications and standards are to be met. As described above, if these notifications and standards are met, medical records can be stored externally.
On the other hand, as per your question, there is no mention of where medical records are stored in GCP, but with regard to the storage of documents or records related to clinical trials, the head of the implementing medical institution must appoint a person in charge of record keeping (GCP Article 41, Paragraph 1) and "-To prevent them from being lost or destroyed, and to make them available upon request Necessary measures shall be taken to ensure that they are not lost or destroyed and that they can be presented upon request." (GCP Article 41, Paragraph 2, Guidance 2). Therefore, it is necessary to have a storage system that can accommodate monitoring and audits conducted by the sponsor and investigations by the clinical trial review committee and regulatory authorities under the responsibility of the person in charge of record keeping, as well as the provision of original documents (original medical records, etc.), etc. for direct inspection. In the case of paper medical records in particular, it is necessary to keep them in the hospital for a while after the completion of the clinical trial. If paper medical records are to be stored externally after the completion of a clinical trial, the timing, storage period, person in charge of storage, storage method, storage location, etc. should be clearly specified in the procedure manual to ensure appropriate operation. (Especially regarding the storage period, it should be noted that in the case of a clinical trial, if the period stipulated in Article 41, Paragraph 2 of the GCP is longer than that stipulated in Article 24, Paragraph 2 of the Medical Practitioners Act, it is subject to the GCP) In monitoring, audit, or investigation by authorities, the original documents must be shown as described above, and at the time of investigation, the original documents must be The original documents must be ordered at the time of the investigation and cannot be substituted with a copy. It is considered possible to change from paper to electronic originals as long as the medical institution has established procedures and the records are kept and stored according to the established procedures to ensure authenticity, legibility, and preservation.
Reason for revision of opinion
In accordance with the revision of the notice regarding the external storage of medical records, etc., the related notice has been partially changed.