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.
The Panel requires an Annual Progress Report (APR) sent by the end of February every year:
- 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 of the previous year and August of the current year of the APR. For Example, for the 2016 APR, the researches approved between September 2015 and August 2016 are required to send the APR by the end of February 2017.
- APR's covering period is from January to December of each year. For example, for the 2016 APR, the researches approved in August 2016: APR's covering period is from August 2016 to December 2016.
- Send the APR to the Panel office in PDF format only (No hard copy required) via e-mail to email@example.com
- 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 (no particular format required) including a completion date and a final progress report to be forwarded to the Panel office via PDF format only.