Guidelines

Any planned research project to be conducted in California requiring the use of a Schedule I or Schedule II Controlled Substance as its main study drug must be submitted to the Research Advisory Panel of California for review and approval prior to start-up in the following areas:

1. Academic Human research of Schedule I or Schedule II medications
2. Non-Human research (animal models or in vitro) of Schedule I medications
3. Academic Research for the Treatment of Controlled Substance Addiction or Abuse utilizing any medications Scheduled or not (SAT Research)
4. Multi/Single Center Clinical Drug Trial Research evaluating or comparing any Schedule II medications AND Multi/Single Center SAT Research

The researches in the a. b. & c. areas require a completed Panel Application Form, Research Protocol, Informed Consent form, Study Drug Monographs, and CV of the PI - 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.

All the application submission packets should be sent in PDF Format 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., the Panel’s Executive Officer - See Contact Us section for the information.

The Panel meets every other month, 6 times yearly - See Meeting Dates and Deadlines section for the 2012, 2013, and 2014 schedules. The Panel's Meeting dates and Deadlines are subject to change, please check this section often.

The outcome/response of the Panel review will bee-mailed in PDF Format within 1-5 days after the completion of the meeting.

The Panel requires that it be notified in PDF Format any significant study drug related SAE's that may emerge during conduction of the research.

Any amendments of the research project should be reported to the Panel in 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 and files the amendments and send out an acknowledge letter.