Any planned research project to be conducted in California requiring the use of a Schedule I or Schedule II Controlled Substance (NO Schedule III, IV, and V) as its main study drug, including comparing drug, must be submitted to the Research Advisory Panel of California for review and approval.
- Researches are categorized into 4 groups:
Group 1: Academic Human Research of Schedule I or Schedule II medications - See Application Forms
Group 2: Research for the Treatment of Controlled Substance Addiction or Abuse utilizing ANY medications (scheduled & non-scheduled) by Academic Institution (SAT Research) - See Application Forms
Group 3: Non-Human Research with animal models OR in-vitro projects of Schedule I medications only - See Application Forms
Group 4: Multi or Single Center Clinical Drug Trial Research sponsored by Pharmaceutical company/CRO evaluating or comparing any Schedule I and II medications AND Multi or Single Center SAT Research - see Clinical Drug Trials
- Submission Requirements for each group:
- Group 1 and Group 2:
- Cover letter
- Panel Application Form
- Research Protocol, Not a Grant Application
- Informed Consent Form (ICF) with Filled-out Informed Consent Form Check List
- Study Drug Monographs or Investigators Brochure (IB)
- Group 3: Requirements are same as group I and group 2 EXCEPT ICF/Check List and Study Drug Monographs/IB not required
- Group 4:
- Cover letter
- Research Protocol
- Template Informed Consent Form with Filled-out Informed Consent Form Check List
- Investigators Brochure
- List of each CA site's address and Principle Investigator (PI)'s name and e-mail address (No CV required)
- Group 1 and Group 2:
- For Group 4 researches, Research Advisory Panel grants the approval to the Sponsor, not the individual MD’s or sites participating in the study. Therefore, the Pharmaceutical company/CRO is required to submit the study applications to the Panel, not the individual MD’s or sites participating in the study.
- Non-Human researches using Schedule II Substances or Any Researches using Schedule III, IV, or V Controlled Substances as a main study drug including comparing drug do NOT require review by the Research Advisory Panel.
- The IRB approval status of all the research studies could be either approved or pending. In order to expedite the Panel’s approval process, the researchers can submit their studies while the IRB approval is pending.
- All the application submission packets should be sent via e-mail in PDF format (Maximum e-mail capacity is increased to 25 MB per e-mail) and also two sets of hard copies of the application packet EXCEPT Non-Human Reseraches should be mailed via U.S. Mail, FedEx, UPS, or any other commercial mail carriers to Y. Jennifer Ahn, Pharm.D. - See Contact Us section.
- The response of the Panel review will be delivered via PDF format within 5-7 business days after the meeting.
- 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.