Guidelines

Any planned research project to be conducted in California that requires the use of a Schedule I or Schedule II Controlled Substance (NO Schedule III, IV, and V) as its main study drug, including comparison drug(s), should be submitted to the Research Advisory Panel of California for review and approval.

  • Research is categorized into 4 groups:

    Group 1: Academic human research of Schedule I or Schedule II medications - See Application Forms

    Group 2: Research into the treatment of controlled substance addiction or abuse utilizing ANY scheduled or non-scheduled medications by an academic institution or by a multi or single center clinical drug trial research sponsored by NIDA and by a pharmaceutical company/CRO : SAT Research - See Application Forms
    Note: SAT Clinical Drug Trials - Do not complete an Application Form

    Group 3: Non-human research with animal models OR in-vitro studies of Schedule I medications only - See Application Forms

    Group 4: Multi or single center clinical drug trial research sponsored by a pharmaceutical company/CRO evaluating or comparing any Schedule I and II medications - see Clinical Drug Trials

  • Submission Requirements for each group:

    1. Group 1 and Group 2:
      1. Cover letter
      2. Panel Application Form
      3. Research Protocol, not a grant application
      4. Informed Consent Form (ICF) with Filled-out Informed Consent Form Check List
      5. Study Drug Monographs or Investigators Brochure (IB)
    2. Group 3: Requirements are same as Group 1 and Group 2 EXCEPT that ICF/Check List and Study Drug Monographs/IB are not required
    3. Group 4:
      1. Cover letter
      2. Research Protocol
      3. Template Informed Consent Form with Filled-out Informed Consent Form Check List
      4. Investigators Brochure
      5. List of each CA site's address and Principle Investigator (PI)'s name and email address (No CV required)
  • For Group 4 research studies, the pharmaceutical company/CRO is required to submit study applications to the Panel, not the individual PIs or sites participating in the study because the Research Advisory Panel of California grants approval to the Sponsor, not the individual MDs or sites participating in the study.
  • Non-human research studies using Schedule II substances, or ANY research studies using Schedule III, IV, or V controlled substances as its main study drug, including comparison drug(s), do NOT require review by the Research Advisory Panel of California.
  • The IRB approval status of all research studies can either be approved or pending. In order to expedite the Panel's approval process, researchers can submit their studies to the Panel while their studies’ IRB approval is pending.
  • All application submission packets should be sent via email in PDF format (Maximum capacity has increased to 25 MB per email) - See Contact Us section.
  • For Group 1, 2, and 4 research application submission packets, TWO sets of hard copies should be mailed via U.S. Mail, FedEx, UPS, or any other commercial mail carriers by the due date to Y. Jennifer Ahn, Pharm.D. - See Contact Us section.
  • Group 3 Non-human research applications should be sent via EMAIL ONLY in PDF format - See Contact Us section.
  • After the Panel reviews submitted study protocols at the Panel meeting, the Panel will issues a PDF format response to the Sponsor/CRO and Academic PI within 30 business days after the Panel meeting. The Panel may take any of the following actions:
    • Issue an approval or denial
    • Require additional documentation
    • Request clarification or changes to the protocol(s), consent form(s), or any other document submitted for approval in conjunction with the study
    • Review at a subsequent Panel meeting if the sponsor/CRO and Academic PI’s reply and resubmission does not adequately or clearly respond to Panel’s concerns.
  • Research studies shall not be started, research subjects cannot be enrolled or screened, before the Panel’s approval
  • Any significant study drug related Serious Adverse Event (SAE) that may emerge during conduction of the research (at the California sites only) should be notified to the Panel via PDF format only.
  • Any amendments of the research project should be reported to the Panel via PDF format only. If the Panel considers that there are major amendments involved, the Panel reviews them at its regular scheduled meetings. Otherwise, the Panel acknowledges, files the amendments and send out an acknowledge letter via PDF format.
  • When the research study is completed, notify the RAPC in a letter form including a study completion date, and a final summary report of the study, and a drug usage log sheet if applicable in a PDF format only.