Drug Evaluation Committee 2008-09 Implementation of Duties of the Head of an Implementing Medical Institution by the Chairman of the Board of Directors
Related classification: Other
Initial release date: 08/2008
Revised release date: Mar 2021
Question
In the case of a medical institution of a medical corporation, which is more appropriate as the head of the implementing medical institution in GCP: the chairman of the board of directors or the head of the hospital? Or, is either appropriate?
Background
A medical institution of a medical corporation used to be headed by Hospital Director A and Deputy Hospital Director B. At that time, it started to establish an implementation system for commissioning clinical trials (preparation of in-hospital SOPs, etc.).
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 the implementing medical institution," 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, President A was performing all "duties of the head of the implementing medical institution. The sponsor noticed the discrepancy between the clinical trial implementation system and the in-hospital SOP after some time had passed (the hospital director A was listed in all clinical trial documents), and discussed the facts and appropriate measures with the site. The implementing medical institution was of the opinion that the "head of the implementing medical institution," as defined in the GCP, was the President A, and that the head of the implementing medical institution in the in-hospital SOP should originally 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 requested us to take action because they believe that the head of the site under GCP should be the hospital director because the president of the site may be in violation of GCP and that the duties of the president of hospital A should be promptly transferred to the president of hospital B. I believe that this is a violation of GCP.
I believe that the "head of the implementing medical institution" under GCP can be either the chairman of the board of directors or the hospital director, as long as he/she can fulfill his/her 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 the implementing medical institution under GCP unless he or she is the hospital director under the Medical Care Act, and that as a result, the chairman is not appropriate as the head of the implementing medical institution under GCP?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The GCP Ministerial Ordinance does not clearly define the definition of "head of a medical institution for implementation.
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 a medical institution 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 medical institution, and the "president" becomes the establisher of the clinical trial review committee as the head of the implementing medical institution, 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 permitted under the GCP Ministerial Ordinance. (See past Opinion 2007-04 ).
Therefore, although the GCP Ministerial Ordinance does not clearly stipulate that the "president" is the head of the implementing medical institution, in consideration of the above points, it would be desirable for the director of Hospital B to serve as the head of the implementing medical institution.
Reason for revision of opinion
Due to the revision of the Medical Care Act, some of the referenced clauses and the opinion text have been changed.