Drug Evaluation Committee 2008-09 Implementation of Duties of the Head of an Investigator Site by the Chairman of the Board of Directors
Related classification: Other
First published: 08/2008
Revised publication date: Mar 2021
Question
In the case of an Investigator Site of a medical corporation, which is more appropriate as the head of the Investigator Site in GCP: the chairman of the board of directors or the head of the hospital? Or, is either appropriate?
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.
At the same time as the construction of the clinical trial implementation system was started, the system was changed to President A and Director B with the incorporation of the medical corporation. The hospital SOP stated that the hospital director was responsible for "duties of the head of Investigator Site," as defined in the GCP, such as contracts, requests for review by the Clinical Trial Review Committee (outside the hospital), and notification to the sponsor and investigators, but in reality, the President A was performing all "duties of the head of Investigator Site. The sponsor noticed the discrepancy between the clinical trial implementation system and the hospital SOP after some time had passed (the hospital director A was listed in all the clinical trial documents), and discussed the facts and appropriate measures with the Investigator Site. The Investigator Site was of the opinion that the "head of the Investigator Site," as defined in the GCP, was the President A, and that the head of the Investigator Site in the hospital SOP should have been listed as the President, not the Hospital Director. Therefore, the sponsor requested that the hospital director in the in-hospital SOP be changed to the chairman of the board of directors and that a written report be provided to the sponsor regarding the erroneous entry.
On the other hand, there seems to be another sponsor who is of the opinion that the head of the Investigator Site under GCP should be the hospital director because the president of the hospital may be in violation of GCP and that the duties of the president of hospital A should be transferred to the president of hospital B as soon as possible.
I believe that the "head of Investigator Site" under GCP can be either the president or the hospital director, as long as they can fulfill their responsibilities under GCP. However, I am not familiar with the difference in responsibilities and authority between the chairman of the board of directors and the hospital director under the Medical Care Act, but is it possible that the chairman of the board of directors cannot fulfill the responsibilities of the head of an Investigator Site under GCP unless he or she is the hospital director under the Medical Care Act, and that as a result the chairman of the board of directors is not appropriate as the head of an 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, the Medical Care Act defines "administrator of a medical institution" (Chapter 4 Hospitals, Clinics and Midwifery Care Facilities, Section 2 Administration, Article 10, etc.) and "president" (Chapter 6 Medical Corporations, Section 3 Institutions, Subsection 5 Directors, Article 46-6), respectively. Regarding the roles of both, "the administrator of the medical institution" is stipulated in Article 10, etc., and "the chairman of the board of directors" in Article 10, etc. "The chairman of the board of directors shall represent the medical corporation and shall have the authority to perform all judicial or extrajudicial acts concerning the business of the medical corporation." (Article 46-6-2), respectively.
The role of the head of an Investigator Site in conducting a clinical trial is stipulated in GCP Article 36, etc., but the content is considered closer to that of a "manager of a medical institution" than to that of a "chairman" under the Medical Care Act. If a clinical trial review committee is established at the relevant Investigator Site, and the "Chairperson" is the head of the Investigator Site as the establisher of the clinical trial review committee, it may be regarded as a clinical trial review committee established by a medical corporation (a clinical trial review committee established by a medical corporation is not recognized under the GCP Ministerial Ordinance. (See past Opinion 2007-04 ).
Therefore, although the GCP ordinance does not clearly stipulate that the "chairman of the board of directors" is the head of the Investigator Site, it is desirable for the director of Hospital B to serve as the head of the Investigator Site in consideration of the above points.
Reason for revision
Due to the revision of the Medical Care Act, some of the referenced clauses and the opinion text have been changed.