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 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 January 1 and February 28 of every year by each Sponsor, Contract Research Organizattion, or Principal Investigator whose research is presently ongoing. (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 Report should be sent in PDF format only (no hard copy required) via e-mail 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 report needs to be submitted until the following year. For example, for a research study approved after October 31, 2022, the first Annual Report will be due between January 1 and February 28 of 2024.

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 Report.

Study Termination: When the study is completed, terminated, or closed, the Panel requires the study applicant to submit a notification letter via PDF format to the Panel. The notification should state the The PR# (Panel Review number) plus the name of the study, and the date the study was completed, closed, or terminated. The study applicant also should forward a copy of the final Annual Progress Report (via PDF format only) with the notification letter.