SOCRA 2023 Annual Conference Brochure - Flipbook - Page 18
SATURDAY, SEPTEMBER 30, 2023
BREAKOUT SESSIONS
TRACK 3:ETHICS IN
RESEARCH
TRACK 4: QUALITY
MANAGEMENT
Time: 3:45 to 4:30
Track: Ethics
Applying Design Thinking to Diversity in Clinical Trials
Currently clinical trials are a linear waterfall process
which is time consuming, inefficient and does not involve
stakeholders from the beginning. By starting from the
needs of underserved people and communities, design
thinking ensures that these needs are fully understood.
By using co-design, all stakeholders are involved in
developing and validating new drugs and devices. The
outcomes will be increased efficacy of drugs and
devices at lower development costs. 329
Presenter: Daniel Steenstra, MD, Professor, OnKai Inc
Time:9:20 to 10:05
Track: Quality Management
The Road from Compliance to Quality in Clinical Trials
The transformation of a clinical trials compliance
program to a quality assurance program presents
substantial challenges. From reorienting the stakeholders
to practical issues such as title and role changes and
developing new worksheets, there are many things to
consider in the effort to improve oversight of studies. A
successful quality assurance program offers a much more
satisfying experience for the entire clinical trials team.
419
Presenter: Eileen Healy, MS, CCRP, Clinical Research
Quality Assurance Coordinator, Roswell Park
Comprehensive Cancer Center
Time: 4:35 to 5:20
Track: Ethics
Placebos in Clinical Research: The Science and Ethics
of "Sugar Pills"
Placebo-controlled trials generate invaluable data and
provide important statistics for treatment efficacy. But
what are the implications of the chosen placebo – will it
yield usable data or confound the results? What about
studies with activities that are difficult to mask (such as
aromatherapy studies)? Dr. Stevens will discuss the
definitions and implications of placebos and present
some historical and current case studies. 331
Presenter: Nicole Stevens, PhD, MS, BA, CCRP, CPT, CPI,
CCRC, Director, Clinical Research, doTERRA
International
TRACK 4: QUALITY
MANAGEMENT
Time:8:30 to 9:15
Track: Quality Management
The Journey of Achieving a Quality Research Program
Through Required Education and Training
This presentation will provide information about
establishing a new departmental education program
including a new employee orientation and robust
competency program. 417
Presenter: Wendy Lloyd, BA, CCRP, LPN, Senior Clinical
Research Quality Analyst-Education, Vanderbilt
University Medical Center
17
Time:10:50 to 11:35
Track: Quality Management
Notes to File: Compliant Practices and Ensuring Data
Integrity
This Note to File (NTF) presentation will review what an
NTF is, current practices, and current problems as well
as Quality System oversight. Lessons learned from audits
and the use of NTFs will also be presented. 421
Presenter: Heather Pham, MS, CCRP, CHRC, Clinical
Research Educator, Providence St. Joseph Health
Time:11:40 to 12:25
Track: Quality Management
Managing Upward: Strategies for Working as a Team
As researchers, we work with a broad variety of
individuals and personalities. One of the more difficult
challenges faced by research coordinators and
managers alike is a colleague who does not respond
well to feedback from the study team. The good news is
that there are a number of things that can be done to
help get the study team functioning smoothly again. This
talk will focus on some of these strategies from the
perspectives of a Research Coordinator, a Compliance
Manager, and a Research Administrator. 423
Presenter: Kevin Smith, MS, MBA, CCRP, Research
Administrator, Cleveland Clinic
Time:1:40 to 3:15
Track: Quality Management
A Quality Improvement Program in Human Subject
Research
As research monitoring and compliance paradigms
evolve, human subject research teams are challenged to
ensure that quality in research maintains or exceeds
expectations and standards. 425/427
Presenters: Jennifer Dolan, MS, LMT, CCRC, Specialist,
Research Quality Improvement, University of Rochester
Kathleen Wessman, MPA, RN, RQAP-GCP, CCRC,
Director, Research Quality Improvement, University of
Rochester
Elizabeth Lyda, BS, RRT, Research Quality Improvement
Specialist, University of Rochester