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Guidelines

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 four groups and the submission requirements of each group are:
    1. Academic Human Research of Schedule I or Schedule II medications-See Application Forms and
    2. Academic Research for the Treatment of Controlled Substance Addiction or Abuse utilizing any medications Scheduled or not (SAT Research) - See Application Forms
      1. Panel Application Form
      2. Research Protocol - Grant Application not accepted
      3. Informed Consent Form with Informed Consent Form Check List
      4. Study Drug Monographs
      5. CV of the Principle Investigator
    3. Non-Human Research with animal models or in vitro projects of Schedule I medications only - See Application Forms
      • Requirements are same as Academic Human Research except Informed Consent Form
    4. Multi or Single Center Clinical Drug Trial Research sponsored by pharmaceutical company evaluating or comparing any Schedule II medications AND Multi or Single Center SAT Research - See Clinical Drug Trials
      1. Cover letter
      2. Research Protocol
      3. Template Informed Consent Form with Informed Consent Form Check List
      4. Address and PI's CV of each California site
      5. Investigators Brochure
  • 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 researches could be either approved or pending.
  • All the application submission packets should be sent via e-mail in PDF format (Maximum e-mail capacity is 10MB per e-mail) and also. Four sets of hard copies of the application packet should be mailed (except Non-Human researches; Non-Human researches require PDF format only) via U.S. Mail, FedEx, UPS, or any other commercial mail carriers to Y. Jennifer Ahn, Pharm.D. - See Contact Us section.
  • Starting 2014, the number of Panel meetings has been changed to 5 times yearly - See Meeting Dates and Deadlines section for the 2015, and 2016 schedules. The Panel Meeting dates and Deadlines are subject to change.
  • The response of the Panel review will be sent via 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 (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.
  • Note: hydrocodone combination medications i.e. Vicodin and Norco became Schedule II effective October 2014.

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