Drug Evaluation Committee 2010-36 Necessity of Revision of Explanatory Documents for Subjects Due to Change in Location of Clinical Trial Review Committee, etc.

Related classification: Obtaining consent

Date of first publication: January 2011

Question

We have been notified that the location of the external Clinical Trial Review Committee to which we have requested a review will be changed.

Please tell us how the site should respond to such a change, mainly regarding the need to revise the explanatory document, the need for IRB deliberation, and the need for subjects to give their consent again.

We believe that if we obtain a document from the investigational review committee regarding the change, provide the information to the subject who is currently enrolled in the study, and keep a record to that effect, there is no need to revise the explanatory document, discuss it with the IRB, or obtain the subject's re-consent. Is there any problem with the above response?

Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)

We believe that the change in the establisher and location of the Investigational Review Board described in the explanatory document constitutes a change in the administrative matters of the clinical trial. Therefore, we do not consider it to be information that would affect the will of subjects participating in the clinical trial to continue the trial, and therefore, we do not think it is necessary to obtain their written consent again. If you are referring to a Clinical Trial Review Committee that has a procedure manual and other documents available for public inspection at its office, it would be desirable to provide information to subjects in a manner similar to that described in your question.

Also, after this change, it will be necessary to provide subjects who will participate in the clinical trial with an explanatory document that contains the latest information and obtain their consent.

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