Regulatory Support

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Regulatory Support

The Regulatory Support Unit provides assistance to investigators before protocols are submitted to regulatory agencies.  Our goal is to interact closely with investigators to help them meet regulatory requirements. Several faculty members in the Center for Clinical Research are members of Institutional Review Board (IRB) review committees and have extensive knowledge of requirements regarding human subjects.

The ACTRI ombudsman, Michael Ziegler, MD, is available to assist junior investigators with requirements for conducting studies involving human subjects.

For more information on Project Management support for clinical trials visit us here or contact us at

HRPP Guidance

Experienced staff in the HRPP can provide guidance with FDA applications. The ACTRI has staff with regulatory experience who can prepare and submit documents to the IRB, including proposals, consent forms, adverse event reports, annual and final reports, and 4-year renewals. For help with IRB submissions, please submit a ACTRI Services Request using the button above. 

Anthony Magit, MD, MPH
Professor of Surgery, Rady Children's Hospital, UC San Diego School of Medicine
Director, UC San Diego Human Research Protections Program
(858) 822-2889

Last updated: 20 Mar 2019