Drug Evaluation Committee 2010-20 Participation by Outside Physicians as Clinical Trial Physicians
Related classification: Principal investigators, subinvestigators, etc.
First published: August 2010
Question
Since there are no physicians in the site who can perform some of the test items in the clinical trial, we are planning to register physicians from outside medical institutions as clinical trial physicians and have them perform some of the test items in the clinical trial. However, the physician concerned said that he could register as a clinical trial assistant physician for this clinical trial, but he would refuse to register as a part-time physician.
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.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stipulated in GCP Article 36, Paragraph 1 and Paragraph 2, Guidance 2, approval by the head of the site is required when assigning part of the important tasks related to the clinical trial to a subinvestigator or a collaborator. In addition, the Medical Care Act 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 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 the 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.