Drug Evaluation Committee 2004-11 Scope of Practice for Physicians Designated as Clinical Trial Collaborators
Related classification: Principal investigators, subinvestigators, etc.
First published: December 2004
Revised publication date: March 2021
Question
The investigator who was appointed as a clinical research associate for a clinical trial in our hospital was transferred, and the IRB did not approve the application for change of the investigator because the new investigator did not meet the requirements for a clinical research associate under our hospital's standard operating procedures (insufficient number of years of clinical experience). Therefore, we came up with the idea of having him participate as a clinical research associate. If the clinical research associate is a physician, what kind of work can he/she perform as a clinical trial-related task? Specifically, I would like to know if it is possible to prescribe investigational drugs, order tests, write case reports, etc. I heard that at some university hospitals, residents and others are involved in clinical trials as collaborators.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The term "investigator collaborator" means a pharmacist, nurse, or other medical personnel who cooperates with the investigator or subinvestigator (hereinafter referred to as "investigator, etc.") in the conduct of a clinical trial at a medical institution under the guidance of the investigator or subinvestigator. (GCP Article 2, Paragraph 18), and we believe that even if the collaborator is a physician, his/her duties are limited to so-called supportive tasks (e.g., assistance in obtaining consent, cooperation in monitoring and auditing, etc.). Therefore, when prescribing a drug, it is necessary to examine the patient himself/herself (Article 20 of the Medical Practitioners Act), but since it is the investigator who examines the subject, we believe that he/she cannot prescribe the investigational drug. The same applies to ordering tests. Although investigators can assist in the preparation of case report forms (e.g., by simply transcribing information from medical records), they are not allowed to write about items that require medical judgment by the investigators.
We believe that there is no difference in the content and scope of work as a cooperative investigator even at a university hospital.
Reason for revision of opinion
With the issuance of the GCP Guidance (No. 0831-15 issued on August 31, 2020 by the Pharmaceutical Affairs Agency of Japan), minor changes have been made to the descriptions.