Clinical Drug Trials

All single or multicenter clinical drug trials involving Schedule I and Schedule II controlled substances as a main study are required to be approved by the Research Advisory Panel of California prior to the start-up of any sites in California. The sponsor conducting the study submits the application for review. Clinical drug trial sponsors include pharmaceutical companies, contract research organizations (CRO), NIH, NIDA, NARC, etc. Below are 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, requesting Panel review. It should include:
    • The title of the study
    • The anticipated startup and completion dates or timeline
    • The number of California sites planned, and the estimated number of subjects in California, plus the total number of subjects in the study
    • The name, mailing address, phone number, and email address of a contact person of the sponsor or CRO. (*It is the study’s responsibility to update RAPC when the contact information changes.)
    • Confirmation of IRB and FDA IND approvals (attach copies of approval letters)

  2. Research Protocol
    • The IRB-approved version (required)

  3. Template Informed Consent Form(s): See California Informed Consent Form Guidelines
    • The IRB-approved version (required)
    • A completely filled out Informed Consent Form Check List, pdf is required
    • Studies that involve DNA/genetic testing, or that collect samples for DNA/genetic testing, or that may share biological samples with others who may conduct DNA/genetic testing on the samples, must provide a separate DNA Informed Consent Form. For guidelines on drafting a valid DNA consent, follow link: DNA/Genetic Informed Consent.

  4. Investigator's Brochure(IB)

  5. List of each California site, including the address and the Principal Investigator’s (PI) name and email address at each site

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, and research subjects cannot be enrolled or screened, prior to the Panel’s approval of the study.