1. 5th Annual Clinical Research
Professional Conference 2009
Case Western Reserve
University
Wolstein Research Building
2103 Cornell Road
Cleveland, OH 44106
KEYNOTE SPEAKER
JANETTE COLLINS-MITCHELL, MT, MS, RN
HISTORY OF THE FDA AND THE
BIORESEARCH MONITORING PROGRAM
Friday, September 18, 2009
Promoting
Excellence In
Clinical
Research:
The Road
To Compliance
Presented by
The Northeastern Ohio Chapter of
Thanks to our sponsors
Clinical Research Management, Inc. and
Clinical & Translational Science Collaborative.
SPACE IS LIMITED
BE SURE TO REGISTER EARLY
REGISTRATION IS NOW OPEN
EDUCATIONAL OPPORTUNITY
CRECs and Nursing Contact Hours available for attendees
Contact hours will be applied for through ACRP

2. CONFERENCE OBJECTIVES
To equip research professionals with the knowledge and tools to conduct research at the highest level of integrity
through compliance.
TARGET AUDIENCE
Principal Investigators, Research Administrators, Clinical Research Coordinators, Clinical Research Associates,
Monitors, IRB Members, Nurses, and other members of the Pharmaceutical and Bioscience Industries.
CONFERENCE AGENDA
7:00 – 8:00 am REGISTRATION BREAKFAST
WELCOME & INTRODUCTIONS
By Carol Fedor, President, NEO ACRP
Topic objectives: Identify three aspects of
appropriate delegation of PI responsibilities for
a clinical trial; describe two elements for
8:00 – 9:00 four minimum site staff training topics.
Janette Collins-Mitchell – History of the FDA and the
Bioresearch Monitoring (BIMO) Program. President, ACRP Northern California Chapter
President and CEO, QD-Quality and Training
Topic Objectives: Identify and utilize the proper policies
and procedures necessary to conduct the various types of
Clinical Bioresearch Monitoring inspections; determine
what is a device product under the applicable statues;
identify the enforcement tools provided for under the
statues enforced by the FDA; recognize and evaluate
study data generated during a clinical trial for the
various types of Bioresearch Monitoring inspections.
10:00 – 10:30 am BREAK
Janette Collins-Mitchell, MT, MS, RN
Nurse Consultant
Program Enforcement Branch, A Division of Bioresearch
Monitoring Office of Compliance, CDRH
Janette Collins-Mitchell is presently employed as a Nurse
Consultant with the Food and Drug Administration. Her
responsibilities include review of medical device pre-
market application submissions and analysis of
inspectional findings to provide recommendations
regarding clinical data and human subject protection. For
over ten years, Janette was a registered nurse in
Community Health and Infection Control in the geriatric
and homecare settings. She spent six years as a
researcher with the Center for Disease Control and
Prevention. Janette holds a Bachelor of Science in
Medical Technology and a Master of Science in
Community and Hospital Administration.
9:00 Investigator Supervisory Responsibilities: The
Changing Landscape of FDA Expectations.
KEYNOTE ADDRESS
adequate PI oversight of a clinical trial; list the
Liz Wool, RN, BSN, CCRA, CMT
Solutions, Inc.
Founder, Training Institute of the Pacific
Carol Fedor, RN, ND, CCRC
Clinical Research Manager
Center for Clinical Research & Technology
University Hospitals Case Medical Center
10:30 FDA Inspections: What to Expect and How
to Prepare. Panel Moderator – Carol Fedor
Topic objectives: Identify three procedures to
complete when preparing for an inspection;
distinguish three areas in which the FDA will
concentrate during an audit; describe how to
best respond to a FDA Form 483.
Dr. Steve Strasbaugh, M.D., FCCP
Assistant Professor of Pediatrics & Medicine
Director, Adult Cystic Fibrosis Program
Rainbow Babies & Children’s Hospital
University Hospitals Case Medical Center
Liz Wool, RN, BSN, CCRA, CMT
President, ACRP Northern California Chapter
President and CEO, QD-Quality & Training
Solutions, Inc.
Founder, Training Institute of the Pacific

3. Steve Kilker, M.S.
Investigator, Bioresearch U.S. Food and Drug
Administration (FDA)
Colleen Rouse, RN, MS, CCRP
Manager, Research Quality Assurance
Cleveland Clinic Foundation
Rev. Harry Werner, Board Certified Chaplain
11:30 Consenting the Vulnerable Patient Director of Pastoral Care
Topic Objectives: Explain the concept of
vulnerability; explain how a surrogate decision
maker is different in a research setting than in a
clinical setting; demonstrate how to involve a
vulnerable person in the informed consent
process for research.
Carmen Paradis, M.D., M.A.
Clinical Assistant Professor of Surgery
CWRU/CCLCM
Director Research Ethics
Board Certified Plastic & Reconstructive Surgery
Roseanne Schott, MBA, BSN, CIP, CCRP
Nurse Researcher
Cleveland Clinic Foundation
Sue Chase, BSN
Director, Clinical Solutions
Clinical Research Management, Inc.
12:30 – 1:30 pm LUNCH
1:30 Mock IRB Session
Topic Objectives: Define the regulatory
requirements for the establishment of an IRB
Committee; understand the process applied by
an IRB committee’s review of a protocol and ICF
to ensure that the rights and welfare of
individuals participating in research are
protected; define the approach to protocol and
ICF development that promote human subject’s
protection.
Dr. Joseph Gibbons, M.D.
Assistant Professor of Medicine CWRU
University Hospitals Case Medical Center
Philip A. Cola, M.A.
Vice President, Research & Technology
Center for Clinical Research & Technology
University Hospitals Case Medical Center
Nicole Deming J.D., M.A.
Assistant Professor of Bioethics
Case Western Reserve University
Dr. Anthony Post, MS, MD
Associate Professor of Medicine, CWRU
Medical Director of Liver Transplantation,
Director of Hepatology, Division of
Gastroenterology
University Hospitals Case Medical Center
University Hospitals Case Medical Center
Barbara Gray
Community Representative
2:30 – 4:00 pm BREAKOUT SESSIONS (select one)
A. Quality and Performance in Clinical Research:
Establishing a Quality Management System for
Success.
Topic Objectives: Define quality as it relates to
the clinical research study; identify three aspects
of a quality policy for a clinical research study;
discuss the five components of a clinical research
quality management system.
Liz Wool, RN, BSN, CCRA, CMT
President, ACRP Northern California Chapter
President and CEO, QD-Quality and Training
Solutions, Inc.
Founder, Training Institute of the Pacific
B. Applying the Principles of Project Management
To Clinical Research
Topic Objectives: Identify principles of good
communication and understand how to apply
them in the day to day management of multiple
clinical trials; think about a research study in
terms of timelines and learn ways to look at the
“big picture” by planning ahead and prioritizing;
understand the importance of ongoing evaluation
of study compliance and learn ways to problem
solve and develop strategies to identify and
avoid potential problems; identify methods to
simultaneously manage the resources of time,
personnel and tools.
Sue Jasper, BSN, RN, CCRC
Project Manger C5 Research
Cleveland Clinic Foundation
Lisa Prcela, RN, CCRP
Project Manager C5 Research
Cleveland Clinic Foundation
4:00 – 4:30 pm EVALUATIONS FOR CONTACT
HOURS & DISMISSAL

4. CONTACT HOURS REGISTRATION INFORMATION
REGISTER EARLY – SPACE IS LIMITED
Registration is NOW OPEN
Registration closes September 16, 2009
Registration fee - $50.00
Registration will be via Eventbrite.
Go to http://excellenceinresearch2009.eventbrite.com/
to register.
If you are unable to register on line please contact Mary
Ann Draves at 216-407-0717 or via email at
mailto:roadtocompliance@gmail.com
Cancellations after September 11, 2009 are nonrefundable.
REGISTRATION INCLUDES BREAKFAST, LUNCH, & SYLLABUS
Thanks to The Northeastern Ohio Chapter of ACRP
for their great effort in presenting this conference
and our sponsors
Clinical Research Management, Inc. and
Clinical & Translational Science Collaborative
Any questions on this event please contact Carol Fedor from
The Northeastern Ohio Chapter of ACRP at 216-844-5524.
Directions to Case Western Reserve University
This program is pending approval for 6.5 clinical
research continuing education contact hours by
ACRP and the California Board of Nursing.
Member Fee – $30 Non-Member Fee – $45
Purchase of Contact Hours will be available online after the event.
Evaluation forms for NON-Members must be turned in after the
conference.
Please be aware that construction projects in the vicinity may require additional time to reach your destination and access parking. We strongly
encourage you to refer to the link provided below for detailed driving directions and updates on traffic delays due to construction.
http://www.uhhospitals.org/case/tabid/1764/fid/1/Default.aspx/CaseMedicalCenter/tabid/848/fid/1/Default.aspx
From the east via Interstate 90, exit at Martin Luther King Jr. Boulevard. Proceed south for about a mile to the East 105th traffic light; cross East 105th and bear right
through the traffic circle, continuing along Martin Luther King Jr. Boulevard to Euclid Avenue. Turn left onto Euclid and turn right onto Mayfield Road to enter the Visitors
Parking garage.
From the east via Interstate 80 (Ohio Turnpike - From Eastern Ohio and Pennsylvania), Take the Ohio Turnpike to the interchange for I-480 West (Exit 187.) Proceed
west on I-480, which merges with I-271 North. Stay north on I-271 then exit at Cedar Road (sharp right turn off exit ramp). Follow Cedar Road westbound toward
Cleveland. (Case is about 20-25 minutes from this point.) Where Cedar starts down a steep hill, look for a sign identifying Case Western Reserve University on your right
at the corner of Murray Hill Road. Continue down Cedar Road under the bridge and veer to the right at the next light on Martin Luther King Jr. Blvd. Turn left onto
Euclid and turn right onto Mayfield Road to enter the Visitors Parking garage.
From the west via the Ohio Turnpike (Interstate 80), exit at Exit 142 and follow Interstate 90 east. Shortly after passing the downtown exits, exit at Martin Luther King
Jr. Boulevard. Proceed south for about a mile to the East 105th traffic light; cross East 105th and bear right through the traffic circle, continuing along Martin Luther King
Jr. Boulevard to Euclid Avenue. Turn left onto Euclid and turn right onto Mayfield Road to enter the Visitors Parking garage.
From the south via Interstate 71 or Interstate 77, proceed north until I-71 (or I-77) merges with Interstate 90. Take I-90 east then exit at Martin Luther King Jr.
Boulevard. Proceed south for about a mile to the East 105th traffic light; cross East 105th and bear right through the traffic circle, continuing along Martin Luther King Jr.
Boulevard to Euclid Avenue. Turn left onto Euclid and turn right onto Mayfield Road to enter the Visitors Parking garage.
Alternate route through downtown Cleveland: Any of the above directions can be altered if desired by taking route 90 into downtown Cleveland and exiting on
Chester Avenue. Head east on Chester to Euclid (just past E. 105th st). Turn left onto Euclid and turn right onto Mayfield Road to enter the Visitors Parking garage.
Parking Information
The parking area on Cornell is the closest parking with the most availability. The rate for all day parking is approximately $9.00. Please be aware
that construction projects in the vicinity may require additional time to access parking. Limited street parking is available throughout University Circle.
Visitors may also park in University garages 29 (adjacent to Severance Hall on East Blvd.) and 53 (adjacent to the Veale Athletics and Recreation
Center at Adelbert Road and Circle Drive.) Parking is also available in University Hospital garages and University Circle Museum lots. For further
information on parking locations, please go to: http://www.case.edu/visit/trans.html