Regulatory Knowledge and Support Service RKS

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

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Who We Are
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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?

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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? 
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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?
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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

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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)

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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

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

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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

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DTRCS Intake Form http//ctsi.ucsf.edu/rks/dtrcs_i
x.php
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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_at_ucsf.edu
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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

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Biostatistics, Research Ethics Design (BREAD)

• Expert consultation in
• Biostatistics
• Study Design and Implementation
• Research Ethics
• Data Management

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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
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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)

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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

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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.

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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 [phone]
• email prosenthal_at_medsfgh.ucsf.edu

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Research Administration Board

• Established to guide priority setting for
• Chancellors office
• Critical assessment of quality improvement
• in OSR
• Represents interests of faculty and staff
• Lynn Pulliam is on RAB

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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