“Regulatory Woes in ResearchHelp is on the Way”
Regulatory Knowledge and Support Service (RKS)
August 10, 2007
Program Overview
The Regulatory 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.
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.
Program Goals
To improve the quality of clinical and
translational research at UCSF and CTSIaffiliated groups by providing:
1. Protocol monitoring and investigator
education in adherence to
regulatory requirements and
standard clinical research practices.
2. Expert regulatory knowledge and
consultation service.
3. Regulatory seminar series.
Who We Are
Regulatory Knowledge & Support (RK S)
Di agnostics and Therapeutics Regulat ory Consulting Service (DTRCS )
Joel Palefsky
PDTS ponsor
Howard Lee
DTRCS Regulatory Advisor
Pharmacometric Consult ant
Washington D.C.
Jeanine Wi ener-Kronish
Program Manager
Julie Nelson
DTRCS Support
Seminar Coordi nator
Joyce Freedman
Of fice of Research
Marlene Berro
RK S Regulatory Advisor
DTRCS Liaison (UCSF)
El izabeth B oyd
RK S Regulatory Advisor
Investigator Education
Recent questions
1. My CHR application was returned for additional
information. What should I do?
2. What approvals do I need to work with human
stem cells?
3. Can I begin my research with a positive financial
disclosure?
4. Where can I go for help in writing a DSMP and
forming a DSMB? What are the UCSF vs. NIH
requirements? Who approves it?
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?”
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?”
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
What We Offer-RKS
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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)
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
RKS Intake Form
http://ctsi.ucsf.edu/
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
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
DTRCS Intake Form
http://ctsi.ucsf.edu/rks/dtrcs_ix.php
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
CTSI Services & Resources
http://ctsi.ucsf.edu/
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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
Biostatistics, Research Ethics & Design (BREAD)
Expert consultation in:
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Biostatistics
Study Design and Implementation
Research Ethics
Data Management
BREAD Staff
S. Claiborne Johnston, MD, PhD, Director
Mary Banach, PhD, Coordinator
Jon Rueter, Financial Coordinator
Julia St. George, Analyst
Biostatistics
Ethics
Peter Bacchetti, PhD (Co-Director)
Su-Chun Cheng, DSc
David Glidden, PhD
Barbara Grimes, PhD
Charles E. McCulloch, PhD
Mark R. Segal, PhD
Bernard Lo, MD (Co-Director)
Lisa Voss, MPH
Richard Wagner, MA
Data Management
Michael Kohn, MD, MPP (Co-Director)
Andrew High
Shameem Mohamed
Christina Morales
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
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)
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
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.
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
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
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