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Annual Progress Report Requirement

The Panel Office is required to monitor all current ongoing Schedule I and Schedule II controlled substance research activity in California.

In order to accomplish this, the Panel requires an Annual Progress Report:

  • From each Sponsor/CRO/PI whose research is presently ongoing (with Clinical Drug trial - Not from individual California site).
  • From each Sponsor/CRO/PI whose researc was approved between September and August of the previous year. (For Clinical Drug Trial - Not from individual California site).
    For example, for the 2015 Annual Progress Report, the researches approved between September 2014 and August 2015.
  • Report's covering period is from January to December of each year.
  • Send the report to the Panel office in PDF format only (No hard copy required) via e-mail by the end of February every year.
  • The Panel will send out an e-mail reminder to the Sponsor/CRO/PI at the end of January each year.
  • There is no particular format required, however, the report should include:
    1. A brief summary of research performed and findings made during the year (this requirement may be augmented by including reprints of papers or copies of reports published)
    2. Research plans for the upcoming calendar year (with indication of any additional controlled substances planned for procurement in the upcoming year)
    3. Notation of any changes in the research project, (substantive changes should be explained in detail so that the Panel can review them as protocol amendments), and
    4. A photocopy of the controlled substances inventory log maintained at you site for record keeping (if applicable).
  • Reporting an annual progress report to the Panel is a mandatory requirement, the Panel Office does not send an acknowledge letter to each Sponsor/CRO/PI.
  • When the study is completed, the Panel requires notification letter (no particular format required) including a completion date and a final progress report to be forwarded to the Panel office via PDF format only.

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