Drug Evaluation Committee 2010-32 Appointment of Medical Expert and Principal Investigator for a Clinical Trial Sponsor
Related classification: Principal investigators, subinvestigators, etc.
First published: October 2010
Question
We (the sponsor pharmaceutical company) would like to outsource a medical expert and plan to make an annual contract with a doctor (one doctor) who works for us. If there is a clinical trial at the medical institution where the medical specialist works, can he/she serve as both the principal investigator and the medical specialist? Even if the medical expert does not perform the duties of the medical expert during the clinical trial period, is there a problem with this being an annual contract?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Medical experts are required to be appointed by the sponsor in accordance with GCP Article 4, Paragraph 2, Guidance 3: "The sponsor shall appoint a qualified medical expert to promptly advise the investigator on medical issues related to the clinical trial. As stated in the GCP Article 4, Paragraph 2, Guidance 3, "The sponsor shall designate a qualified medical expert to promptly advise the sponsor on medical issues related to the clinical trial. This role is different from the roles and responsibilities of the principal investigator, coordinating investigator, and efficacy and safety evaluation committee, and therefore we believe that it is problematic for a medical expert to concurrently serve as the principal investigator for the relevant clinical trial.