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 sponsor such as pharmaceutical company, NIH, NIDA, NARC, etc, conducting the study - to the Panel for review and approval.

A checklist has been provided (in PDF format) to aid sponsors in preparing single or multicenter clinical trial protocol submissions for Panel review.

For Informed Consent, please refer to California Informed Consent Guidelines section provided on this website.

• Clinical Drug Trials Submission Checklist, pdf

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