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Regulatory Knowledge and Support Service (RKS ) August 10, 2007

“Regulatory Woes in Research- Help is on the Way”. Regulatory Knowledge and Support Service (RKS ) August 10, 2007. Program Overview.

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Regulatory Knowledge and Support Service (RKS ) August 10, 2007

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  1. “Regulatory Woes in Research- Help is on the Way” Regulatory Knowledge and Support Service (RKS) August 10, 2007

  2. Program Overview TheRegulatory Knowledge and Support Service (RKS), part of the UCSF Clinical and Translational Science Institute (CTSI), is available to help researchers understand and meet the many regulatory and compliance requirements.

  3. RKS/DTRCS 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.

  4. Program Goals To improve the quality of clinical and translational research at UCSF and CTSI-affiliated groups by providing: • Protocol monitoring and investigator education in adherence to regulatory requirements and standard clinical research practices. • Expert regulatory knowledge and consultation service. • Regulatory seminar series.

  5. Who We Are

  6. Investigator Education Recent questions My CHR application was returned for additional information. What should I do? What approvals do I need to work with human stem cells? 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?

  7. Investigator Education You have more questions-We have answers “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?” 

  8. Investigator Education “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?” “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?”

  9. Protocol Monitoring  • Provide protocol monitoring for protocols performed using CCRC resources • Protocol review and written evaluation of adherence to regulatory guidelines of AE reporting and protocol deviations

  10. What We Offer-RKS • RKS offers consultation and regulatory guidance in the following areas: • Committee on Human Research (CHR) • Institutional Animal Care and Use Committee  (IACUC) • Radioactive Drug Safety Committee • Biosafety Committee • Human Stem Cell Use • HIPAA • Conflict of Interest (COI)

  11. What We Offer-RKS • FDA: • Investigational New Drug Application (IND) • New Drug Application (NDA) or Biological License Application • Investigational Device or Non-significant Risk Exemption

  12. RKS Intake Form http://ctsi.ucsf.edu/

  13. What We Offer-DTRCS • DTRCS and The Regulatory Knowledge and Support Center for Drug Development Science Integrated Model-based Pharmacometric Analysis of Clinical Trials (IMPACT)offers consultation and services for studies of: • Pharmacokinetics • pharmacodynamics • clinical pharmacology

  14. What We Offer-DTRCS • mechanism of pharmacological action • proof of concept • and any other translational, exploratory, learning or confirming studies of a preventive, therapeutic, and diagnostic agent. • IMPACT provides state-of-the-art services using • advanced modeling and simulation technologies

  15. DTRCS Intake Form http://ctsi.ucsf.edu/rks/dtrcs_ix.php

  16. Contact Info • Submitting a request: 
Request an RKS or DTRCS consultation by completing a RKS/DTRCS intake form at: http://ctsi.ucsf.edu/RKS/request. 

 • For more information, call us at 415-476-3426 • or email marlene.berro@ucsf.edu

  17. CTSI Services & Resources http://ctsi.ucsf.edu/ • Biostatistics, Research Ethics, and Design (BREAD) • Data Management • Biomedical Informatics • Translational Technologies • Regulatory Knowledge and Support • Clinical Research Center • Community Engagement • Strategic Opportunity Support • Clinical & Translational Sciences Training • Career Advancement

  18. Biostatistics, Research Ethics & Design (BREAD) • Expert consultation in: • Biostatistics • Study Design and Implementation • Research Ethics • Data Management

  19. BREAD Staff S. Claiborne Johnston, MD, PhD, Director Mary Banach, PhD, Coordinator Jon Rueter, Financial Coordinator Julia St. George, Analyst Biostatistics Peter Bacchetti, PhD (Co-Director) Su-Chun Cheng, DSc David Glidden, PhD Barbara Grimes, PhD Charles E. McCulloch, PhD Mark R. Segal, PhD Data Management Michael Kohn, MD, MPP (Co-Director)  Andrew High Shameem Mohamed Christina Morales Ethics Bernard Lo, MD (Co-Director)  Lisa Voss, MPH Richard Wagner, MA Research Design Mark J. Pletcher, MD, MPH (Co-Director) Douglas Bauer, MD Kirsten Bibbins-Domingo, PhD, MD Ken Covinsky, MD Ralph Gonzales, MD, MSPH Carl Grunfeld, MD, PhD Thomas Newman, MD, MPH Rebecca Smith-Bindman, MD Jeffrey A. Tice, MD Paul Varosy, MD

  20. BREAD Recharge • Free/charged hour policies • Initial consult or first hour free • Billable hours • Infrastructure or service hours • Rates (~$150/hr for faculty, less for staff) • Currently unable to recharge UCSF Affiliates (VA-SFGH)

  21. Innovative Translational Collaboration (ITC) The mission of ITC is to: • Facilitate the performance of innovative translational research at UCSF. • Identify clinical, translational, and basic research programs that may benefit from collaboration with other groups, typically representing different disciplines. • Of highest priority will be the facilitation of collaboration between clinical and basic science researchers to initiate innovative collaborative research programs

  22. Innovative Translational Collaboration (ITC) Specific goals include: • To bring together clinical and basic researchers to facilitative innovative translational research. • To serve as a resource for the UCSF community for advice regarding interdisciplinary translational research. • To facilitate interaction between UCSF researchers and industry in the establishment of new translational research programs.

  23. Innovative Translational Collaboration (ITC) • To sponsor meetings between researchers from different disciplines with intersecting areas of interest, including both small meetings between research groups and targeted symposia. • The CTI is directed by Dr. Philip Rosenthal, Professor, Department of Medicine. • Contact ITC at: Phone: 415-206-8845 email: prosenthal@medsfgh.ucsf.edu

  24. Research Administration Board • Established to guide priority setting for • Chancellor’s office • Critical assessment of quality improvement • in OSR • Represents interests of faculty and staff • Lynn Pulliam is on RAB

  25. RAB-What We Have Done • Met with CHR and are working to implement an      electronic system • Identify areas that faculty and staff need help: Scientific review for CHR? Help in monitoring? What services do you need? • Work with OSR to streamline processes

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