Drug Evaluation Committee 2010-20 Participation by Outside Physicians as Clinical Trial Physicians
Related classification: investigators, subinvestigators, etc.
First published: August 2010
Question
Since the Investigator Site does not have a physician who can perform some of the investigational tests, we are considering registering a physician from an outside medical institution as a subinvestigator to perform some of the investigational tests. However, the physician concerned said that he/she could register as a clinical trial assistant investigator for this clinical trial, but he/she would refuse to register as a part-time investigator.
For the above reasons, we would like to register a physician who belongs to a medical institution with which we do not have a clinical trial agreement as a subinvestigator. Is this a problem? In the clinical trial agreement, the name of the other medical institution will be listed as the affiliations of the investigator.
JPMA's Opinion
As stipulated in GCP Article 36, Paragraph 1/Section 2, Guidance 2, approval by the head of the Investigator Site is required when assigning part of the important tasks related to the clinical trial to the investigator or collaborator. The Medical Care Act also stipulates that hospital administrators must supervise physicians, dentists, pharmacists, and other employees working at the hospital. Therefore, we believe that there is a problem with approving an outside physician who has no employment or contractual relationship with the Investigator Site as a sub-clinical investigator and having him or her engage in clinical trial operations.
As for the affiliation in the clinical trial agreement between the sponsor and Investigator Site, if the above agreement exists, it would be acceptable to state the medical institution, department, and title of the department to which the physician belongs.