Drug Evaluation Committee 2010-37 Access to medical records when two affiliated medical institutions conduct a single clinical trial
Related classification: Record keeping
Date of first publication: January 2011
Question
Background
Please tell us about the contract related to access to medical records at a medical institution conducting a clinical trial and its affiliated clinics.
A medical institution operates outpatient and inpatient clinics as separate medical institutions (let's say Hospital A and Clinic B). Patients who come for an outpatient consultation are first examined at the clinic. If hospitalization is necessary, the patient is transferred to Hospital A and receives treatment at Hospital A thereafter. Patients who come to the clinic for outpatient care do not go to Hospital A from the beginning, but are first transferred to Hospital A via Clinic B. Hospital A and Clinic B share an electronic medical record, which allows both to access medical records, test results, etc. So far, the situation is the same as in question No. 2007-08.
The clinical trial we want to conduct this time is an "outpatient" trial, but the clinic is inadequate in terms of facilities and staff, so we are applying to Hospital A as the medical institution to conduct the trial. The principal investigator and all subinvestigators work at both Hospital A and Clinic B, so patients who are referred by Clinic B will be incorporated into the trial by coming to Hospital A and obtaining consent. The difference from question No. 2007-08 is that Clinic B does not explain consent or conduct eligibility checks, except for referrals for clinical trials. The monitors and CRC (SMO) will refer to the medical records of Hospital A only (if there is no history of admission to Hospital A, there is effectively no medical record). Under these circumstances, the clinical trial is currently being conducted under a bilateral contract between Hospital A - the sponsor.
Question
Although there is no plan to conduct clinical trial activities such as obtaining consent or eligibility testing at Clinic B in the future, would it be a problem under GCP to conclude a contract that would allow Hospital A to access Clinic B's medical records for safety confirmation purposes?
In question No. 2007-08, you answered that Clinic B will also be included in the clinical trial notification.
We are considering concluding a tripartite memorandum of understanding between Hospital A, Clinic B, and the sponsor that stipulates access to medical records and the preservation of confidentiality, and including access to Clinic B's medical records in the consent document.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Although this is an outpatient trial, only Hospital A, which specializes in inpatient care, is the site of the trial. I would like to state my opinion on this issue.
If the "safety confirmation" in your question refers to the confirmation of the original data obtained during the visit to Clinic B from the electronic medical record, which is necessary to confirm the eligibility of the subject, then there should be no problem. However, if the original data obtained at Clinic B is to be used as clinical trial data, it is necessary to obtain the subject's consent by stating in the explanatory document that the sponsor, clinical trial review committee, and regulatory authorities may directly inspect the data. Furthermore, as mentioned in your question, it is necessary to conclude a three-party agreement including Clinic B regarding direct inspection and preservation of source data.
Clinic B is not a medical institution that conducts the clinical trial, but is considered to be another hospital that makes referrals to Hospital A. Therefore, it is not necessary to include Clinic B in the clinical trial notification.