Drug Evaluation Committee 2007-08 Contract for a single clinical trial at two affiliated medical institutions
Related classification: Other
Date of first publication: Jan. 2008
Question
We are contacting you to ask your opinion on how we should conclude a contract with a medical institution that has an "outpatient clinic".
One 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 Clinic B (Clinic B is an outpatient clinic and is attached to Hospital A). If hospitalization is required, the patient is transferred to Hospital A and thereafter receives treatment at Hospital A. The outpatients do not go to Hospital A from the beginning, but first go through Clinic B before being transferred to Hospital A. Hospital A and Clinic B share an electronic medical record, which allows both to access medical records, test results, and other information. So, I want to conduct an "inpatient clinical trial" at this medical institution,
- Bilateral contract between Hospital A and the sponsor
- Three-party contract between Hospital A, Clinic B and the sponsor
Which of the following forms is appropriate?
Clinic B performs the following services
- Tests to diagnose whether the disease is a target disease or not
- Diagnosis to determine if the disease is eligible or not
- Confirmation of eligibility (to explain the clinical trial only to eligible patients)
- Explanation of the clinical trial outline (no consent document is used, only a brief verbal introduction)
Patients referred by Clinic B are transferred to Hospital A and are once again incorporated into the clinical trial through the process of "explaining consent" and "obtaining consent.
Clinic B does not explain or obtain consent, but the test data for eligibility verification remains at Clinic B. When the monitor performs the SDV, he or she refers to the electronic medical record at Clinic B.
Therefore, should we make it a three-party contract instead of a two-party contract and specify that Clinic B is also participating in the clinical trial under the contract? However, on the other hand, only Hospital A delivers the investigational drug, and the actual start of the clinical trial (obtaining consent) also takes place at Hospital A. If a three-party contract is used, then Clinic B, which is only responsible for screening, must be listed as the medical institution conducting the clinical trial. If a three-party contract is used, Clinic B, which is responsible only for screening, would have to be listed in the clinical trial notification as the Investigator Site, which would double the work of site selection, safety reporting, etc. for the two institutions.
The above case has been reported in several medical institutions, and although it may not be a critical issue in terms of GCP, we would appreciate your opinion.
JPMA's Opinion
I will answer your question on the assumption that the differences in testing equipment, measurement methods, etc. between Hospital A and Clinic B do not conflict with the study protocol.
Hospital A is the Investigator Site because it is the hospital where the investigational drug will be administered after consent is obtained. However, since Clinic B is also involved in the said clinical trial, it is necessary for the Clinical Trial Review Committee to review the appropriateness of patients who come to Clinic B to participate in the clinical trial at Hospital A, as well as to take the following actions.
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(1)If the tests to be performed at Clinic B cannot be performed as part of routine medical care, the tests are for the purpose of a clinical trial, and written consent must be obtained before the tests are performed at Clinic B (GCP Article 50). Therefore, it is necessary for the Investigator Site to enter the notification of the clinical trial and sign a contract with the sponsor.
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(2)
If the tests to be performed at Clinic B are tests that are performed within the scope of routine medical care, Clinic B is not an Investigator Site. However, even in such a case, the following points should be noted/addressed
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1.It must be stated in the explanatory document that the results of the tests conducted at Clinic B will be used as clinical trial data and that the sponsor, etc. will have direct access to the data from the said Clinic B.
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2.The eligibility of subjects must be the responsibility of the investigators and subinvestigators (at Hospital A) (GCP Article 44).
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3.Source documents related to the tests performed at Clinic B must be stored for the period specified in GCP Article 41, Paragraph 2.
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4.Since electronic medical record information is shared between Hospital A and Clinic B, and test results at Clinic B cannot be directly viewed under a bilateral contract between Hospital A and the sponsor, a tripartite contract including Clinic B must be concluded.
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In addition to direct inspection, the contract should include items related to preservation of source documents, confidentiality, monitoring and auditing by the sponsor, acceptance of investigations by the Clinical Trial Review Committee and regulatory authorities, compensation for damage to health (when invasive tests are performed), and cost sharing.
In order to minimize the burden on subjects and other related parties due to the complicated procedures described above, we suggest that you reconsider conducting the initial examination at Hospital A.