Drug Evaluation Committee 2020-30 Setting up an unblinded collaborator
Related classification: 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 precautions that need to be taken.
JPMA's Opinion
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 will be engaged in the study so that the study will be conducted appropriately under the supervision and responsibility of the investigator, etc., as well as to establish an implementation system to maintain blindness (for example, preparing a procedure manual, setting 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 not including unblinded information in source documents such as medical records). 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).