Drug Evaluation Committee 2004-06 Collection of Medical Information from Other Medical Institutions Where Subjects Visited During Clinical Trials
Related classification: Other
First published: December 2004
Revised publication date: December 2021
Question
When a patient undergoing a clinical trial at our hospital visits another medical institution, we may not be able to obtain the desired results despite our written or telephone requests to the attending physician to provide information in order to obtain the necessary patient information at that institution.
If, despite several attempts to gather information, sufficient information is not provided, is it sufficient to report only the information obtained at that point in time?
Also, can we request other medical institutions to disclose our medical records for the purpose of gathering information in clinical trials?
If so, what procedures should I follow to comply with the law?
I would appreciate it if you could tell me about the legal procedures for disclosure of medical records in clinical trials.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Regarding the provision of medical information among medical institutions, as far as we have been able to ascertain, there is a provision in Article 1-4, Paragraph 3 of the Medical Care Act, Article 16-2 of the Regulations Concerning Insurance Medical Institutions and Insurance Medical Care, and Article 10 of the Guidelines Concerning Provision of Medical Information, etc. (September 12, 2003, Medical Policy No. 0912001, "Establishment of Guidelines Concerning Provision of Medical Information, etc. (Medical Practitioners Act)", attached). However, none of them specify the scope of information to be provided.
Medical information provided by other medical institutions during a clinical trial is important to confirm the safety and efficacy of the clinical trial (in particular, to ensure the safety of the subjects).
The procedure for requesting other medical institutions to provide medical information is as follows. First, after obtaining written consent from the subject, the investigator will make a written request with the consent document attached. When making the request, it is important to clarify that medical information from other medical institutions is important to ensure the safety of the subjects participating in the clinical trial and the scope of information required, so that other medical institutions will understand and be more likely to provide the medical information. The information provided and the information obtained from the subject (if the subject is prescribed a drug at another medical institution, we will ask the subject to bring the drug to us to confirm its contents) will be included in the case report within the scope of the information provided.
In the event that the need to confirm the contents of medical records at other medical institutions arises, which cannot be assumed but is mentioned in your question, the investigator will make a request in the same manner as above after obtaining the subject's consent in writing. However, as far as we have researched, we have not found any legally prescribed procedures for disclosing medical records to third parties, so we believe that this should be done after consulting with the other medical institution and respecting its in-house procedures. In addition, it is important to note that disclosure of medical records is usually permitted only to the patient himself/herself or to the bereaved family if the patient is deceased, and that the protection of personal information must be taken into consideration.
In any case, we request that these be recorded in the medical record as appropriate, and that requests for and receipt of medical information be made in writing and kept as part of the source documents.
Reason for revision of opinion
The opinion text has been partially changed in accordance with the development of related laws and regulations.