Regulatory Knowledge Support (RKS)
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.
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?
People
The RKS Service is directed by Alan Venook, MD, Professor of Clinical Medicine in the Division of Medical Oncology.
RKS Regulatory Advisor Marlene Berro, MS, Clinical Specialist in the Division of Medical Oncology at UCSF, coordinates access to external consultants covering a wide variety of therapeutic areas.