Drug Evaluation Committee 2011-20 Recording and storing clinical trial-related information in electronic medical records shared with other medical institutions
Related classification: Record keeping
First published: Sep 2011
Revised release date: April 2013
Question
The medical institution in question is a large private hospital. It has entered into agreements with nine other medical institutions in the region to digitize almost all information, including examination data and medical records in patients' inpatient charts, so that patients can check their medical information on the reference screen from other institutions.
Patients are individually given a consent form to confirm in advance whether or not they are willing to provide information to other facilities. However, since some patients participated in a clinical trial during their hospitalization, we are wondering how we should handle documents related to the trial (consent forms, medical record sheets, concomitant medications, information on adverse events, etc.) in such cases.
In view of the fact that the above documents are an integral part of the medical record, is it acceptable to provide all the information regarding the clinical trial to other facilities? (Even after participation in a clinical trial is completed, is it also a problem if the patient is seen at another medical institution, not being able to know the past treatment from the clinical trial?) (Is it a problem to not know the past treatment in the clinical trial if I visit other institutions even after the trial? (Is it a problem to not know the past treatment in a clinical trial even after participation in a clinical trial is completed? (For example, consent forms for clinical trials can be provided, but not those that are analogous to efficacy and safety, etc.) Please also provide any specific examples or legal basis for such information.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 13, Paragraph 1, Guidance 3 (17), <4> of the GCP states that "Other necessary matters (matters regarding preservation of confidentiality of information belonging to the sponsor, etc.)" should be included in the clinical trial contract, and it is agreed that confidential information is to be preserved in the contract between the site and the sponsor.
Therefore, the sponsor is legally obligated to preserve information related to the study protocol, investigational new drug summary, and explanatory documents, etc., for which the sponsor holds intellectual property rights, in accordance with the said agreement. In addition, information regarding the properties, preparation, dosage and administration, efficacy, and safety of the investigational drug (clinical trial results), except for information that is publicly known, is also considered to be subject to the same obligation of confidentiality. However, records in medical records generated by clinical trial activities and clinical trial-related documents that are considered part of the medical records in your question are not considered to be records with intellectual property rights, so there should be no problem in sharing them with other sites.
It is recommended that details of information belonging to the sponsor be discussed with the sponsor.
Reason for revision of opinion
The provisions to be referred to have been changed in accordance with the issuance of the GCP Guidance (December 28, 2012, Pharmaceutical and Food Safety Bureau of Japan, No. 1228/7).