Drug Evaluation Committee 2015-12 Outsourcing of Inspections Related to Clinical Trials from Medical Institutions (Part 2)
Related classification: Other
Date of first publication: August 2015
Question
In the case where tests stipulated in the protocol cannot be performed at the site and therefore tests are performed at other sites, is the following response acceptable for designating a physician who performs tests at other sites as a subinvestigator for the clinical trial? (The sponsor, the medical institution, and the other hospital have concluded an agreement regarding the implementation of the test.)
If only tests are performed at the other hospital and the final evaluation decision is made by the investigator at the site of the clinical trial, the tests performed at the other hospital are considered to be within the scope of normal duties of the investigator at the other hospital, and there is no need to appoint a physician to be a subinvestigator. If the tests and evaluations are performed at another hospital and the evaluations are used as the basis for the case report form, designation as a subinvestigator is required.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If the medical institution that outsources testing only performs the testing and does not obtain subject consent, prescribe the study drug, or evaluate the study, it does not fall under the category of a medical institution conducting the study, and the physician at the other hospital who performs the testing is not considered a subinvestigator. In addition, we believe that having an outside physician who has no employment or contractual relationship with the site engage in the clinical trial work as a subinvestigator is problematic from the perspective of the Medical Care Act (see 2010-20 ).
Therefore, if a physician from another hospital evaluates the test results of a clinical trial, the investigator is required to make a final decision based on the test and evaluation results from the other hospital and write the source documents or case report form.