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 - not from individual California site - and PI, whose research was approved between September and August of the previous year to be forwarded to the Panel office in PDF format by February 25th every year. For example, for the 2011 Annual Progress Report, the researches approved between September 2010 and August 2011 need to be sent by February 25, 2012. The Panel will send out an e-mail reminder to the Sponsor/CRO/PI at the end of January every year.
There is no particular format required, however, the report should include:
- A brief summary of research performed and findings made during the calendar year (this requirement may be augmented by including reprints of papers or copies of reports published)
- Research plans for the upcoming calendar year (with indication of any additional controlled substances planned for procurement in the upcoming year)
- 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
- A photocopy of the controlled substances inventory log maintained at you site for record keeping (if applicable).
Since 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.
The Panel also requires notification of completion, and a final report including a completion date, to be forwarded to the Panel office in PDF format when each study is completed.