Clinical Drug Trials

The Research Advisory Panel requires all single or multicenter clinical drug trial protocols involving Schedule II controlled substances as a main study drug to be submitted by the sponsor conducting the study to the Panel for review and approval prior to the start-up of any sites in California. Clinical Drug Trials Sponsors include pharmaceutical companies, NIH, NIDA, NARC, etc. Below is the items required for Panel review:

1. Cover Letter

   The cover letter should be in the form of a request letter, from the sponsor conducting the single or multicenter clinical trial study, for Panel review of the protocol to be used in the study. It should include:

   • The title of the study
   • An anticipated startup and completion time lines
   • The number of California sites planned, and estimated number of subjects
   • The name, mailing address, phone number, and e-mail address of a contact person of the sponsor or CRO.
2. Research Protocol

3. Template Informed Consent Form: See California Informed Consent Guidelines

   • the final IRB’s approved version required
   • review of the Consent Form Check List, pdf required before submitting
4. Address and CV of the PI’s of each California Site
5. Investigators Brochure

The Research Advisory Panel grants the approval to the Sponsor or CRO conducting the clinical drug trial, not the individual PI's or sites participating in the study. Therefore, the Sponsor or CRO conducting the clinical drug trial is required to submit the study applications to the Panel, not the individual PI's or sites participating in the study.

Research studies shall not be started, research subjects cannot be enrolled or screened, before the Panel’s approval.