Drug Evaluation Committee 2008-09 Implementation of Duties by the Chairperson Regarding the Head of the Investigator Site
Related classification: Other
First published: 08/2008
Revised publication date: Mar 2021
Question
In the case of medical institutions operated by medical corporations, which is the appropriate “Investigator Site leader” under GCP: the Chairman of the Board or the Hospital Director? Or is either acceptable?
Background
An Investigator Site of a medical corporation used to be headed by Hospital Director A and Deputy Director B. At that time, it started to establish a clinical trial implementation system (e.g., preparation of in-house SOPs) to be commissioned to conduct a clinical trial.
Around the same time we began establishing our clinical trial infrastructure, the organizational structure changed to Chairman A and Hospital Director B following the transition to a medical corporation.The hospital’s internal SOPs specified that the Hospital Director was responsible for performing the “duties of the head of the Investigator Site” as defined by GCP—including contracts, submitting review requests to the Institutional Review Board (external to the hospital), and notifying the sponsor and the principal investigator—but in practice, Chairman A was performing all of these duties.The sponsor did not notice the discrepancy between the clinical trial implementation structure and the internal SOPs until some time had passed (since all clinical trial documents listed Hospital Director A as the responsible party), and therefore consulted with the Investigator Site regarding the facts of the matter and the appropriate course of action.The Investigator Site maintained the position that Chairman A was fulfilling the responsibilities of the “head of the Investigator Site” as defined by GCP, and that, strictly speaking, the internal SOP should have designated the Chairman—rather than the Hospital Director—as the head of the Investigator Site.Consequently, we requested that the clinical trial sponsor amend the hospital director’s title in the hospital’s SOP to “Chairman” and provide a written report to the sponsor regarding the incorrect entry.
On the other hand, it appears that some other sponsors have requested corrective action, arguing that designating the Chairman as the head of the Investigator Site under GCP could constitute a violation of GCP and that the position should be held by the Hospital Director; therefore, Chairman A’s duties should be promptly transferred to Hospital Director B.
I believe that the “head of the Investigator Site” as defined under GCP can be either the Chairman or the Hospital Director, provided that the responsibilities under GCP can be fulfilled.However, while I do not fully understand the differences in responsibilities and authority between a Chairman and a Hospital Director under the Medical Care Act, is it the case that unless the individual is a Hospital Director under the Medical Care Act, they cannot fulfill the responsibilities of the head of the Investigator Site under GCP, and consequently, a Chairman is unsuitable to serve as the head of the Investigator Site under GCP?
JPMA's Opinion
The definition of "head of Investigator Site" is not clearly defined in the GCP ordinance.
On the other hand, under the Medical Care Act,the “administrator of a medical institution” (Chapter 4: Hospitals, Clinics, and Midwifery Clinics; Section 2: Administration; Article 10, etc.) and the “chairperson” (Chapter 6: Medical Corporations; Section 3: Organs; Subsection 5: Directors; Article 46-6) are each defined separately, and the “chairperson” is an officer of a medical corporation.Furthermore, regarding their respective roles, the “administrator of a medical institution” is defined in Article 10 et seq., while the “chairperson” is defined as follows: “The chairperson shall represent the medical corporation and have the authority to perform all judicial and extrajudicial acts pertaining to the business of the medical corporation” (Article 46-6-2).
The role of the head of the Investigator Site conducting a clinical trial is stipulated in GCP Article 36 and related provisions; however, the nature of this role is considered to be closer to that of the “administrator of the Investigator Site” under the Medical Care Act rather than that of the “Chairperson.”Furthermore, if an Institutional Review Board (IRB) has been established at the medical institution in question, and the “Chairperson” serves as the head of the Investigator Site and acts as the sponsor of the IRB, the IRB may be deemed to have been established by the medical corporation (IRBs established by medical corporations are not permitted under the GCP Ordinance; see past opinion 2007-04 ).
Therefore, while the GCP Ordinance does not explicitly stipulate that the “Chairperson” must serve as the head of the Investigator Site, considering the points mentioned above, it is considered desirable for the Director of Hospital B to assume the role of head of the Investigator Site.
Reason for revision
Due to the revision of the Medical Care Act, some of the referenced clauses and the opinion text have been changed.