Drug Evaluation Committee (7) Response to the Consolidation of Medical Institutions
Related classification: Other
First published: December 2004
Question
As you are aware, consolidation and closure of national hospitals and sanatoriums is being promoted by policy.
In July of this year, our hospital will be merged with a national sanatorium hospital, and a new hospital (the current hospital will be used as is, and the sanatorium will be merged with the new hospital and named after the new medical institution) will be established.
In the case of a national hospital, in addition to GCP, accounting laws are applied to contractual relationships, and upon integration, the accounting of the current hospital and the new hospital will be independent.
Therefore, the contract at the current hospital will be concluded until the end of June of this year, and a new contract will be concluded at the new hospital after July.
We are not sure if this merger will be treated as the establishment of a new hospital or simply a change in the name of the medical institution under the Medical Service Act, but if we consider it as the establishment of a new hospital for the continued implementation of the clinical trial, please tell us about the measures required under GCP (IRB establishment, review, contract, investigational drug management, handling of subjects, etc.) for the medical institution to conduct the trial and what the client is supposed to do. Please explain what the sponsor is required to do.
If the name of the medical institution is changed, at a minimum, an official document must be issued stating that the new hospital will take over all debts and credits of the current hospital related to the clinical trial when the contract is signed.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If hospitals are merged and a new hospital is established, the following actions may be taken.
(1) As a medical institution
There will be a process of reconciling the "Procedures for Operations Related to Clinical Trials" that were prepared at each hospital. As a result, the following tasks related to the clinical trial, as well as the persons responsible and in charge of them, will be clarified, which may result in changes to the content of the contract for the clinical trial.
-
i. IRB: The IRB chairperson and committee members are elected. ii.IRB: Appointment of the chairperson and committee members and establishment of the secretariat
-
ii.Review: Requirements for approval of meetings, definition of normal and expedited review, and other matters related to the operation of the IRB
-
ⅲ.Contract: Contracting officer and contractor
-
ⅳ.Clinical trial staff: Qualification requirements for investigators and subinvestigators, as well as conditions and duties of investigative collaborators
-
v.Investigational drug management: Appointment of investigational drug manager and storage location
-
vi.Record keeping: Appointment of a person in charge of record keeping, securing a storage location and storage method
-
vii.Others (in-hospital procedures in case of adverse events, procedures for payment of subject cost reduction expenses and uninsured combined medical treatment expenses, etc.)
In order to continue the clinical trial, it may be necessary to deliberate whether or not the clinical trial can be conducted at the new hospital in terms of the implementation system (facilities, clinical trial staff, etc.). If there is no change in the principal investigator, the only question is whether the new hospital meets the requirements for conducting the clinical trial.
After the approval is granted, when the clinical trial is continued under the facility system and procedure manual of Hospital A, no new procedures such as deliberation are necessary for the clinical trial being conducted at Hospital A. However, for the clinical trial being conducted at Hospital B, it is necessary to deliberate on the feasibility of conducting the clinical trial at Hospital A (the new hospital).
As for the treatment of subjects, we think it is necessary to explain that the medical institution will be changed and confirm their willingness to continue the clinical trial (we do not think it is necessary to obtain their consent again in writing, but for subjects who participated in the clinical trial at Hospital B, it may be necessary to record their willingness to continue in the medical record, etc. because the trial may be conducted at Hospital A (new hospital)). (We think it is necessary to record confirmation of the intention to continue in the medical records, etc.).
In addition, it is unethical to interrupt the administration of investigational drugs to subjects who are currently participating in a clinical trial for administrative reasons, so it is desirable that all procedures be completed by the time of integration.
(2) As a sponsor
We will investigate and select the personnel in charge of operations and procedures at the new site, as well as whether the new hospital meets the facilities and other requirements for continuing the clinical trial in question. (For example, if the clinical trial is already being conducted at Hospital A and the same facilities and procedures will be used as at Hospital A after the merger, no new selection is considered necessary.) In addition, we may also consider directly inspecting the documents or records related to the ongoing clinical trial in order to confirm that they have been transferred to the new hospital.
In the case of a change in investigators, it is necessary to investigate the eligibility of the investigators and obtain agreement from the investigators on the protocol and explanatory documents (in the case of explanatory documents, we believe that agreement on the existing documents is required, although they are originally to be prepared). Then, after confirming that there are no problems, a notification of change is submitted to the authorities, and the contracting procedure with the investigational site is proceeded.