Drug Evaluation Committee 2015-12 Outsourcing of Inspections Related to Clinical Trials from Investigator Sites (Part 2)
Related classification: Other
Date of first publication: August 2015
Question
In the case where an Investigator Site is not able to perform the tests stipulated in the clinical trial protocol and therefore performs the tests at another hospital, is the following response acceptable for designating a physician who performs the tests at the other hospital as a sub-clinical investigator? (The sponsor, Investigator Site, and the other hospital have concluded an agreement regarding the test implementation.)
If only tests are performed at the other hospital and the final evaluation decision is made by the investigator at the Investigator Site, 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.
JPMA's Opinion
If the Investigator Site only performs the tests and does not obtain subject consent, prescribe the investigational drug, or evaluate the study, it is not an Investigator Site and the physician at the other hospital who performs the tests is not considered a subinvestigator. In addition, we believe that having an outside physician who has no employment or contractual relationship with the Investigator 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 judgment based on the test and evaluation results from the other hospital and write the source documents or case report form.