2024 Guidelines

Any planned research project to be conducted in California involving a Schedule I or Schedule II controlled substance (not a Schedule III, IV, or V controlled substance) as its main study drug or as a comparison drug for human studies; or a Schedule I controlled substance for non-human studies; or any controlled substance use disorder treatment research utilizing any scheduled or non-scheduled medication - must be submitted to the Research Advisory Panel of California for review and approval.

In order to complete the Research Advisory Panel of California application process:

1. determine the Group that the research falls under (see below); then
2. complete the submission requirements for the designated Group

Note: Panel approval is required before any research study can be started, and before any research subjects can be screened or enrolled.

A. Research is Categorized into Four (4) Groups

B. Submission Requirements for Each Group

Note: Researchers should obtain IRB and FDA (IND), or IACUC approval of their studies before submitting their studies for review by the Research Advisory Panel of California.

1. Group 1 - Academic Human Research:
   
   
   1. Cover letter
   2. RAPC Application Form: ACADEMIC HUMAN RESEARCH W/ SCHEDULE I OR II DRUG, pdf
   3. IRB-approved and FDA IND-approved (where applicable) Research Protocol, not a grant application
   4. IRB-approved Informed Consent Form(s) (ICF)
   5. Filled-out Informed Consent Form Checklist(s)
   6. Experimental Subject’s Bill of Rights with an area for the participant’s signature. See - Experimental Subject's Bill of Rights
   7. Study Drug Monograph(s) and/or Investigators Brochure(s)
   8. All application submission packets should be sent via email in PDF format (maximum capacity is 25 MB per email) to - RAPC@doj.ca.gov
   9. Two sets of hard copies mailed via U.S. Mail, FedEx, UPS, or any other commercial mail carriers by the due date to the RAPC Executive Officer - See Contact Us section


2. Group 2 – Substance Use Disorder Treatment Research:
   
   Note: For multisite studies, the sponsor/pharmaceutical company/CRO is required to submit the study application to the Panel, not the individual principal investigators (PIs) or study sites participating in the study. The Research Advisory Panel of California grants approval to the sponsor, not the individual researchers or study sites participating in the study. Please include study information: See Clinical Drug Trials.
   
   
   1. Cover letter
   2. RAPC Application Form: RESEARCH IN THE TREATMENT OF SUBSTANCE ABUSE (SAT), pdf
   3. IRB-approved and FDA IND-approved (where applicable) Research Protocol, not a grant application
   4. IRB-approved Informed Consent Form(s) (ICF)
   5. Filled-out Informed Consent Form Checklist(s)
   6. Experimental Subject’s Bill of Rights with an area for the participant’s signature. See - Experimental Subject's Bill of Rights
   7. Study Drug Monograph(s) and/or Investigators Brochure(s)
   8. All application submission packets should be sent via email in PDF format (maximum capacity is 25 MB per email) to - RAPC@doj.ca.gov
   9. Two sets of hard copies mailed via U.S. Mail, FedEx, UPS, or any other commercial mail carriers by the due date to the RAPC Executive Officer - See Contact Us section


3. Group 3 - Non-Human Research:
   
   
   1. Cover letter
   2. RAPC Application Form: NON-HUMAN RESEARCH W/ SCHEDULE I DRUG, pdf
   3. Complete Research Protocol, not a grant application
   4. IACUC approved (where applicable) Research Protocol
   5. Calculations for the requested quantities of Schedule I controlled substances
   6. All application submission packets should be sent via email ONLY in PDF format (maximum capacity is 25 MB per email) to - RAPC@doj.ca.gov


4. Group 4 – Multicenter or Single-Center, Clinical Drug Trial Research Sponsored by a Pharmaceutical Company/CRO:
   
   

   Note: For Group 4 research studies, the pharmaceutical company/CRO is required to submit the study application to the Panel, not the individual principal investigators (PIs) or study sites participating in the study. The Research Advisory Panel of California grants approval to the sponsor, not the individual researchers or study sites participating in the study.

   
   
   1. Cover letter from the sponsor or CRO
   2. Study information: See Clinical Drug Trials
   3. IRB-approved and FDA IND-approved (where applicable) Research Protocol, not a grant application
   4. IRB-approved Informed Consent Form(s) (ICF)
   5. Filled-out Informed Consent Form Checklist(s)
   6. Experimental Subject’s Bill of Rights with an area for the participant's signature. See - Experimental Subject's Bill of Rights
   7. Drug Monograph(s) and/or Investigators Brochure(s)
   8. List of each CA site's address and the principal's investigator’s (PI) name and email address
   9. All application submission packets should be sent via email in PDF format (Maximum capacity has increased to 25 MB per email) – to RAPC@doj.ca.gov
   10. Two sets of hard copies must also be mailed via U.S. Mail, FedEx, UPS, or any other commercial mail carriers by the due date to the RAPC Executive Officer - See Contact Us section

Note:

• Applicants should obtain IRB, FDA, or IACUC approvals 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/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, see the following 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 is 25 MB per email) to RAPC@doj.ca.gov.


• Any significant study drug related serious adverse event (SAE) that may emerge during conduct of the research study shall be reported to the Panel via email (PDF format) only.


• Non-human research studies using Schedule II controlled substances, or ANY research study using a Schedule III, IV, or V controlled substance as its main study drug, including comparison drug(s), do NOT require review by the Research Advisory Panel of California.

C. Approval Process

The Panel reviews study applications (that have completed all submission requirements) at the Panel meeting and issues a response in PDF format to the academic principal investigator or sponsor/CRO. A response can be expected within 30 business days after the Panel meeting. The Panel may take any of the following actions:

1. Issue an approval or denial
2. Require additional documentation
3. Request clarifications or changes to the protocol, consent form(s), and/or any other study documents submitted for approval in conjunction with the application
4. Review the application at a subsequent Panel meeting if the reply and resubmission by the sponsor/CRO or academic principal investigator does not adequately or clearly respond to the Panel’s concerns

D. Amendments to RAPC - Approved Studies

Any amendments to 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 issues an acknowledgement email or approval 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 to study documents, 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 to the study, 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 IACUC approval of the amendments, where applicable

E. Completed, Closed, or Terminated Studies

When the research study is completed, closed, or terminated, notify RAPC by submitting a final report in letter form via email in PDF format. The final report should include the following:

1. For all study types (Group 1, 2, 3, and 4 research):
   1. PR# (Panel Review number) plus the title of the study
   2. A study completion date
   3. A final summary report of research performed and findings of the study
   4. The drug usage log sheets (if applicable)