2023 Guidelines

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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), or research on the treatment of controlled substance use disorder, 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 controlled substances - See Application Forms

    Group 2: Human research on the treatment of controlled substance use disorder utilizing ANY scheduled or non-scheduled medications. Academic research studies see - Application Forms. Clinical drug trial research studies see - Clinical Drug Trials

    Group 3: Non-human research with animal models OR in-vitro studies of Schedule I controlled substances 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 controlled substances - 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(s) (ICF) with the filled-out Informed Consent Form Check List
      5. Study Drug Monographs or Investigator's Brochures (IB)
    2. Group 3:
      1. Cover letter
      2. Panel Application Form
      3. Research protocol, not a grant application
      4. Calculations for the quantities of controlled substances requested
      5. Institutional Animal Care and Use Committee (IACUC) approvals for the use of animals, when applicable.
    3. Group 4:
      1. Cover letter
      2. Research Protocol
      3. Template Informed Consent Form(s) with the filled-out Informed Consent Form Check List
      4. Investigator's Brochure
      5. List of each CA site's address and Principle Investigator (PI)'s name and email address
  • For Group 4 research studies, the Sponsor/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 PIs 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.
  • Researchers should obtain IRB and FDA approval of their study BEFORE submitting the study for review by the Research Advisory Panel of California.
  • All human research studies that may involve DNA/genetic testing, or that collect samples for DNA testing, or that may share 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, see link: DNA/Genetic Informed Consent
  • Please ensure that the most up-to-date drafts of the protocol and consent form(s) are submitted for RAPC review. Changes to the protocol and/or consent form(s) after an application is submitted to RAPC can result in delays in the review of the application.
  • All application submission packages should be sent via email in PDF format (the maximum capacity has increased to 25 MB per email) - See Contact Us section.
  • For Group 1, 2, and 4 research application submission packages, 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 Tanveer Khan, Pharm.D. c/o Enid Camps - 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, and 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 conduct of the research study should be notified to the Panel via email (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 regularly scheduled meetings. Otherwise, the Panel acknowledges, files the amendments and sends out an acknowledgement or letter via PDF format.

    The amendment application should be sent to rapc@doj.ca.gov. The amendment application should include:
    1. Human Studies (Group 1, 2, and 4 research):

      1. A summary document of the revisions, identifying, for each revision, the original wording and the revised wording, along with the section and page number for each revision
      2. Copies of the revised protocol and informed consent form(s), as applicable, with changes in tracked changes
      3. Final copies of the revised protocol and informed consent form(s)
      4. Copies of applicable approval letters (IRB, FDA, etc)

    2. Non-Human Studies (Group 3 research):

      1. A summary document of the revisions, identifying, for each revision, the original wording and the revised wording, along with the section and page number for each revision
      2. A copy of the revised protocol with changes in tracked changes
      3. A final copy of the revised protocol
      4. Calculations for any additional quantities of Schedule I Controlled Substances requested for approval
      5. A copy of the Institutional Animal Care and Use Committee (IACUC) approval of the amendments, where applicable
  • When the research study is completed, notify RAPC by submitting a final report in letter form via email in PDF format. The final report should include the PR# (Panel Review number) plus the title of the study, a study completion date, a final summary report of the study, and the drug usage log sheet (if applicable).