Annual Progress Report Requirement

The Panel Office is required to monitor all current ongoing Schedule I and Schedule II controlled substance research and substance use disorder treatment research activity in California. The applicant’s submission of an annual progress report is a mandatory requirement to maintain ongoing RAPC approval of the research project.

The Panel requires that an annual progress report is submitted by the end of January each year by each Sponsor, Contract Research Organization (CRO), or Principal Investigator (PI) whose research is presently ongoing. For example, for research occurring between January 1, 2025 and December 31, 2025, the 2025 annual progress report is due between December 31, 2025 and January 31, 2026. (For multisite studies, the annual progress report should be submitted by the Sponsor or CRO, not from the individual California sites.) A separate annual progress report is required for each research project.

The annual progress reports should be emailed in PDF format (no hard copy required) to RAPC@doj.ca.gov.

Period Covered/Exception for Research Studies Approved in November and December

Each annual progress report should cover the period from January 1 through December 31 of each year. An exception is made for the first annual report of studies approved in November and December: For each Sponsor/CRO/PI whose research was approved between November 1 and December 31, no annual progress report needs to be submitted until the following year. For example, a research study approved on November 1, 2025 will submit the first annual progress report covering the prior 14 months between December 31, 2026 and January 31, 2027.

The Annual Progress Report should include the following:

1. The PR# (Panel Review number) plus the name of the study
2. 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)
3. Any significant findings or occurrences that may have taken place
4. Research plans for the upcoming calendar year (requests to approve the procurement of additional controlled substances should be sent separately in an amendment application - See Guidelines, section D)
5. A photocopy of the controlled substances inventory log maintained at the site for record keeping (if applicable)

Study Amendments

Applications for review and approval of study amendments must be submitted separately from the annual progress report (See Guidelines, section D). Any application for an amendment to a research study should be timely sent to the Panel -- well in advance of its proposed implementation date to enable Panel review of the amendment request.

Study Completion or Termination and Final Report

When the study is completed or terminated, the Panel requires the Sponsor/CRO/PI to submit a notification letter and the final report. The notification letter should state the PR# (Panel Review number) plus the title of the study, and the date the study was completed or terminated. The notification letter and final report are sent as email attachments in PDF format (no hard copy required) to RAPC@doj.ca.gov.