Any planned research project to be conducted in California requiring the use of a Schedule I or Schedule II Controlled Substance, NOT 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 prior to start-up in the following areas:
- Academic Human Research of Schedule I or Schedule II medications
- Non-Human Research (animal models or in vitro) of Schedule I medications
- Academic Research for the Treatment of Controlled Substance Addiction or Abuse utilizing any medications Scheduled or not (SAT Research)
- Multi or Single Center Clinical Drug Trial Research sponsored by a pharmaceutical company evaluating or comparing any Schedule II medications AND Multi or Single Center SAT Research
The researches in the a. & c. areas require a completed Panel Application Form, Research Protocol (not a Grant Application), Informed Consent form, Study Drug Monographs, and CV of the PI. The researches in the b area require the same as above except Informed Consent Form - See Application Forms section for more information.
The Multi/Single Center Clinical Drug Trial Research and SAT Research in the d. area do not require an application form, instead, it requires Cover letter, Research Protocol, Template Informed Consent Form, Address and PI's CV of each CA site, and Investigators Brochure to be submitted by the Sponsor/CRO conducting the study, not by the individual site's PI - See Clinical Drug Trial section for the detailed information.
Non-Human researches using Schedule II Substances or Any Researches using Schedule III, IV, or V Controlled Substances as a main study drug do NOT require review by the Research Advisory Panel - See DEA Controlled Substance Listings for the detailed information.
The IRB approval status of all the researches could be approved or pending.
All the application submission packets should be sent in PDF Format (Maximum e-mail capacity is 10 MB per e-mail) and also Two sets of hard copies of the application packet 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 for information.
Starting 2014, the number of Panel meetings has been changed to 5 times yearly - See Meeting Dates and Deadlines section for the 2014, and 2015 schedules. The Panel Meeting dates and Deadlines are subject to change.
The response of the Panel review will be delivered via e-mail in PDF format within 1-5 days after the meeting.
Any significant study drug related Serious Adverse Event (SAE) that may emerge during conduction of the research should be notified to the Panel via email only in PDF format.
Any amendments of the research project should be reported to the Panel via email only in PDF format. If the Panel considers that there are major amendments involved, the Panel reviews them at its regular scheduled meetings. Otherwise, the Panel acknowledges and files the amendments and send out an acknowledge letter via email.