Drug Evaluation Committee 2010-55 Contracting parties on the side of medical institutions in clinical trial contracts
Related classification: clinical trial contracting procedures
Date of first publication: Apr. 2011
Question
Originally one hospital was divided into a hospital (inpatient entity) and a clinic (outpatient entity) of the same corporation. The physicians work between the two facilities and have the same affiliation.
There was a request to conduct a clinical trial in which the clinical trial activities would be performed at both the hospital and the clinic. In this case, since the contractor is a corporation, is it OK to make it a two-party contract between the representative of the facility and the sponsor? Or, should it be a three-party contract between the representative of each of the two sites and the sponsor?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stipulated in Article 13 of the GCP, a clinical trial contract must be concluded between the sponsor and the site. When a clinical trial is shared between a hospital and a clinic, there is no problem with either a two-party contract between the hospital and the clinic and the sponsor, or a three-party contract between the hospital, the clinic, and the sponsor. Furthermore, as long as the name and location of the medical institution where the clinical trial is to be conducted are clearly indicated, it would be acceptable to conclude a contract between the chairman of the medical corporation, who is a higher level than the heads of the hospital and clinic, and the sponsor.
In either case, please be sure to clarify the roles and responsibilities of each party. Please also refer to Question No. ( 2004-14 ) "Points to keep in mind when conducting a single clinical trial at multiple medical institutions.