Clinical Drug Trials
The Research Advisory Panel requires all single or 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 single or multicenter clinical trial protocol submissions for Panel review:
- Clinical Drug Trials Submission Checklist
[PDF 37 kb / 1 pg]
Note: Approval for single or 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 clinical study, and, accordingly, applications will not be accepted from individual MD’s or sites participating in a single or multicenter study.
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