SOCRA 2023 Annual Conference Brochure - Flipbook - Page 13
FRIDAY, SEPTEMBER 29, 2023
BREAKOUT SESSIONS
TRACK 5: RESPONSIBLE
CONDUCT OF RESEARCH
Time:1:15 to 2:00
Track: Responsible Conduct
Being a SMART Whistleblower: Responding to
Suspicious Behavior and Suspected Wrongdoing
Dr. McIntosh will discuss how decision-making strategies
can help navigate situations where someone: 1) observes
suspicious behavior or wrongdoing, or 2) is asked to
engage in suspicious behavior or wrongdoing. These
social-cognitive decision-making strategies—seeking
help, managing emotions, anticipating consequences,
recognizing context, and testing assumptions—support
effective information gathering, professional decisionmaking, and whistleblowing practices. Additional
considerations, such as how to identify misconduct, how
strategies may differ when the wrongdoer is an authority
figure, and differences between taking formal and
informal action will also be discussed. 509
Presenter: Tristan McIntosh, PhD, Assistant Professor of
Medicine, Washington University School of Medicine
Time:2:05 to 2:50
Track: Responsible Conduct
What's All The Fuss About ESG and How Does it Affect
My Clinical Trial Program?
Environmental, Social, and Governance (ESG) is
impacting clinical trial sites from the CRO and sponsor
perspective. Sites and clinical research associates
should be aware of what ESG is and how to set a
strategy to use resources effectively and meet the
standards ethically. 511
Presenter: Kelly Willenberg, DBA, RN, CHRC, CHC, CCRP,
CEO, Kelly Willenberg LLC
TRACK 5: SCIENTIFIC
(GENOMICS, PHARMACOKINETICS, ETC)
Time:3:25 to 4:10
Track: Scientific
Ancillary Materials in Manufacture of Cellular
Therapies.
Given the potential to resolve a large number of unmet
clinical indications, there has been an increase in the
number of clinical studies using stem cell therapies
derived from Induced pluripotent stem cells (iPSC). iPSC
are a type of pluripotent stem cell that can be
generated from adult somatic cells. This talk will focus
on the raw materials used in the manufacture of cellular
therapies and their regulatory requirements. 513
Presenter: Anat Feldman, PhD, MBA, CCRP, Manager,
Business Development, Clinical Applications, STEMCELL
Technologies Canada Inc.
SOCRA ANNUAL CONFERENCE BROCHURE
TRACK 5: SCIENTIFIC
(GENOMICS, PHARMACOKINETICS, ETC)
Time:4:15 to 5:00
Track: Scientific
Psychedelic Clinical Trials in Concussion and Traumatic
Brain Injury Research
Ms. Grewal will provide practical insights into the
current state of this emerging area of medicine and
research including but not limited to international
regulatory review, study design considerations, and
recruitment strategies. Additionally, Ms. Grewal will
review target populations and discuss how cultural
competency plays an important role when working with
veteran, professional athletic, and first responder
communities. 515
Presenter: Jaspreet Grewal, MSc, CCRP, CEO, Knowde
Group, Inc.
TRACK 6: TRAINING
Time:1:15 to 2:00
Track: Training
Unconventional Applications of REDCap from New Hire
Training to Administrative Support
While many institutions offer clinical research training
basics for new hires, learning the nuisances of a specific
protocol and the associated lexicon can be
challenging. Oftentimes, staff express frustration over a
lack of resources in these areas and this deficiency in
knowledge can lead to preventable mistakes.
Additionally, such training resources should be evolving
and made readily available through internet-based
access. REDCap can be harnessed to create a library of
resources (and interactive activities) for new and
current staff for any project in order to tackle training
issues. This presentation will explore this concept and its
implementation in a nontherapeutic longitudinal data
collection study. 609
Presenter: Elizabeth Solinger, MS, CCRP, Senior Clinical
Research Coordinator, The Ohio State University
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