Annual Progress Report Requirement

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

The Panel requires that an annual progress report (APR) be submitted between December 31 and January 31 by each Sponsor, Contract Research Organization, or Principal Investigator whose research is presently ongoing. For example, for research occurring between January 1, 2024 and December 31, 2024, the APR for year 2024 is due between Dember 31, 2024 and January 31, 2025. (For multisite studies, the APR should be submitted by the Sponsor or CRO, not from the individual California sites.) A separate APR is required for each research project.

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

Period of time 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 calendar year, except for studies approved in November and December -- which should cover the prior 13 to 14 months. Therefore, for each Sponsor/CRO/PI whose research was approved after October 31, no annual progress report needs to be submitted until the following year. For example, for a research study approved after October 31, 2023, the first annual progress report will be due between January 1 and February 28 of 2025.

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. Research plans for the upcoming calendar year (requests to approve the procurement of additional controlled substances should be sent separately as an amendment request)
4. A photocopy of the controlled substances inventory log maintained at the site for record keeping (if applicable)

Study Amendments: Requests for Panel review of study amendments must be submitted separately from the Annual Report

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. Applications for study amendments must be submitted separately from the annual progress report.

Study Termination: When the study is completed, terminated, or closed, the Panel requires the study applicant to submit an electronic notification letter via email (PDF format) to the Panel. The notification letter should state the PR# (Panel Review number) plus the title of the study, and the date the study was completed, closed, or terminated. The study applicant also should forward a copy of the final report by email only (via PDF format) with the notification letter to RAPC@doj.ca.gov.