Drug Evaluation Committee 2020-30 Setting up an unblinded collaborator
Related classification: Principal investigators, subinvestigators, etc.
Date of first publication: November 2020
Question
Regarding the setting of an unblinded collaborator in a double-blind study, is it possible to designate a physician who is not a clinical trial investigator as an unblinded collaborator? If so, please let us know if there are any points to be noted.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
It is possible to designate a physician who is not a clinical investigator as an unblinded collaborator. In such a case, we would need to explain the procedures related to the clinical trial to those who are to be engaged in the clinical trial so that the clinical trial is conducted appropriately under the supervision and responsibility of the investigator, etc., as well as to establish an implementation system to maintain blindness (e.g., preparation of procedure manual, establishment of non-blinded areas, no inclusion of non-blinded information in source documents such as medical records (non-blinded information should be included in source documents used only by non-blinded collaborators), and the use of a blinded area). It is important to establish a system for maintaining blindness (e.g., creating procedures, setting up an unblinded area, not including unblinded information in source documents such as medical records (unblinded information should be included in source documents used only by unblinded collaborators), and obtaining written pledges from blinded staff not to disclose unblinded information).
Please also refer to the past Opinion 2004-11 for precautions to be taken when using physicians as study collaborators. For more information on the Uniform Form 2, please refer to the "Guidance on the New Uniform Form for Requesting Clinical Trials" issued by the Center for Promoting Clinical Trials of the Japan Medical Association (JMAC).