Drug Evaluation Committee 2018-29 Job titles of investigators, etc. to be included in the explanatory documents for subjects
Related classification: Obtaining consent
Date of first publication: October 2018
Question
In the guidance 1 of Article 51, Paragraph 1 of GCP, it is stipulated that "the name, title, and contact information of the investigator or subinvestigator" should be included in the explanatory document for subjects. If "physician" is used, then the title should be "clinical investigator".
If "physician" is used, the job title would be "Principal investigator: Taro Yamada, Title: Physician," and the title of the principal investigator, who is assumed to be a physician, would be listed as "physician" again. On the other hand, if there is no corresponding title (e.g., "medical staff"), how would it be described as a job title?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Although GCP and related notices stipulate that the title of the investigator should be stated in the notification of clinical trial and clinical trial protocol, it is also acceptable to simply state "physician" or the like (see Opinion 2013-24).
We believe that the same description is acceptable in the explanatory document for subjects. Therefore, it is considered acceptable for the investigator to decide the description based on the organization and system of the relevant medical institution and the ease of understanding for subjects.
If there is no job title, it is acceptable to use the name of the department or "physician" or "medical staff" as the job title.