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Multicenter Trials

The Research Advisory Panel requires all multicenter clinical drug trial protocols involving Schedule II controlled substances to be submitted by the pharmaceutical company conducting the study - to the Panel for review and approval.

A checklist has been provided (in PDF format) to aid pharmaceutical companies in preparing multicenter clinical trial protocol submissions for Panel review:

Note: Approval for multicenter clinical trial protocols is granted to the pharmaceutical company conducting the study, not the individual sites participating in the study. Hence the review and approval process is initiated by and granted to the pharmaceutical company sponsoring the multicenter study, and, accordingly, applications will not be accepted from individual MD’s or sites participating in a multicenter study.

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