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 research was approved between September and August of the previous year (with Clinical Drug Trial - Not from individual California site).
- Covering Period is from January to December of each year.
- Send an Annual Report to the Panel office in PDF format only (No hard copy) via e-mail by the end of February every year.
- For example, for the 2014 Annual Progress Report, the researches approved between September 2013 and August 2014 need to be sent by February 28, 2015.
- 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:
- 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)
- 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).
- 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 including a completion date and a final report to be forwarded to the Panel office via PDF format only.