Drug Evaluation Committee 2012-41 Outsourcing of Inspections for Clinical Trials from Medical Institutions
Related classification: Other
Date of first publication: Feb. 2013
Question
Hospital A, a candidate for a clinical trial site, does not have facilities for imaging tests (let's say CT) as stipulated in the study protocol, so we were told that the tests will be performed at nearby Hospital B. (This item is a test stipulated in the study protocol and is related to the evaluation of efficacy and safety.)
In question No. 2007-08, it was previously determined that "the test to be performed is a test that cannot be performed within the scope of routine medical care," but should we consider the same in this case?
We have been requesting CT examinations to Hospital B when they are necessary for general medical care (we have a contract with Hospital B for examinations outside of clinical trials), so Hospital B does not need to be listed in the clinical trial notification and there is no need for a clinical trial contract between Hospital B and the sponsor (as long as there is a contract between Hospital A and Hospital B that meets GCP Article 39-2, there should be no problem). (As long as there is a contract between Hospital A and Hospital B to the extent that Article 39-2 of the GCP is satisfied. Or should we consider that Hospital B will also be conducting the clinical trial, and that it is necessary for it to be included in the notification of the clinical trial and to have a clinical trial agreement with the sponsor?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Your question does not specify which hospital will conduct the evaluation of the efficacy and safety of the imaging test as stipulated in the protocol, but if the physician at Hospital B will evaluate the results of the imaging test in accordance with the evaluation criteria stipulated in the protocol, Hospital B must be listed in the clinical trial plan notification as the site of the study. Hospital B is required to be listed in the clinical trial plan notification as an investigational site.
If the clinical technologist at Hospital B performs the examination, sends the images to Hospital A, and the investigator at Hospital A performs the medical evaluation, Hospital B is not an executing medical institution and does not need to be listed in the clinical trial plan notification. Hospital B is not a medical institution and there is no need to include it in the clinical trial plan notification. Please refer to Article 39-2 of GCP and Question No. 2007-08.
Even without medical evaluation, if the protocol stipulates unusual imaging methods, imaging conditions, or requirements for examiners, it may be necessary to provide detailed explanations and education to Hospital B. In such a case, the clinical trial plan should be submitted to Hospital B. In such a case, the clinical trial plan should be submitted to Hospital B. In such a case, the clinical trial plan should be submitted to Hospital B. In such cases, it may be better to include the contract research organization in the clinical trial protocol.