RKS • Regulatory Knowledge and Support Service

As knowledge and technology advance, performing clinical and translational research involves an increasingly complex regulatory environment. The Regulatory Knowledge and Support Service, part of the UCSF Clinical and Translational Science Institute, is available to help researchers understand and meet the many regulatory and compliance requirements in the pre-award and post-award process. The RKS Program includes the Diagnostics and Therapeutics Regulatory Consulting Service (DTRCS), which is available to provide advice and guidance to investigators planning submissions to the U.S. Food and Drug Administration.

Services:

RKS can help with questions such as:

• What approvals do I need to work with human stem cells?
• I am a new investigator at UCSF designing a phase I/II trial and am not sure I need an IND to test an approved drug at a unapproved dose. Where do I start?
• Can I begin my research with a positive financial disclosure?
• Where can I go for help in writing a DSMP and forming a DSMB? What are the UCSF vs. NIH requirements? Who approves it?
• I want to test if a higher dose of drug X will benefit my patients. Which regulations do I need to follow?
• I would like to use a medical device that has been approved in another country but not yet in the US. Do I need to get an FDA approval to use it in a clinical trial? If so, what do I have to do and where to start?
• My CHR application was returned for additional information. What should I do?
• A pharmaceutical company has asked me if I was interested in working with them to develop a new drug. What do I need to know? What are the points to consider?

RKS Resources

Information Sheet for Clinical Laboratory Testing

RKS News:

Oct 10th: RKS presents second regulatory seminar, "All about Investigational New Drug Applications"

Presentations available online

Submitting a request:

Request an RKS or DTRCS consultation by completing the online form.

If you have not been contacted by a member of the RKS/DTRCS consulting team within three business days of submitting your request, call us at 415-476-3426 or email marlene.berro@ucsf.edu.

For more information:
Please send comments or questions to RKS faculty and staff at:
Email: marlene.berro@ucsf.edu
Phone: 415-476-3426

Who We Are:

The RKS Service is directed by Alan Venook, MD, Professor of Clinical Medicine in the Division of Medical Oncology.

RKS Regulatory Advisors are Marlene Berro, MS, Clinical Specialist in the Department of Anesthesia and Elizabeth Boyd, PhD, Assistant Adjunct Professor in the Department of Clinical Pharmacy at UCSF.

DTRCS is directed by Howard Lee, MD, PhD, Associate Adjunct Professor, Director, Center for Drug Development Science in the Department of Biopharmaceutical Sciences in the School of Pharmacy and Julie Nelson, MBA, Associate Director, UCSF Center for Drug Development Science (CDDS).