Drug Evaluation Committee 2016-31 Order for Clinical Trial-related Inspections by Physicians other than the Principal Investigator
Related classification: Other
Date of first publication: October 2016
Question
When I asked a clinical investigator to order a test specified in the protocol, I was told to ask a physician who is not also a clinical investigator to order the test. When I told him that I wanted to ask either the principal investigator or a subinvestigator to order the test, he assured me that it should not be a problem because it has been allowed in other trials in the past.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If the "tests specified in the study protocol" in your question are tests unique to the study that are not performed in ordinary medical care, it would be desirable for the investigator, subinvestigator or collaborator to order the tests to ensure that they are properly performed in accordance with the prescribed procedures in the study protocol, etc. On the other hand, "the protocol specifies the procedures to be followed in the clinical trial protocol.
On the other hand, if the "tests specified in the protocol" are not specific to a clinical trial and are also performed in ordinary medical care, and if the investigator has thoroughly examined the subject's condition prior to ordering the tests and determined that it is appropriate to perform the tests in accordance with the protocol, then the investigator may order the tests under the direction of the investigator. If the investigator has determined that it is appropriate to perform the tests in accordance with the study protocol, then there should be no problem for another physician to order tests on behalf of the investigator under the direction of the investigator. However, even in this case, there may be conditions or points to be noted that are unique to this clinical trial when performing the tests, and it is necessary for the investigator to confirm that this information is communicated to the person performing the tests.