SOCRA 2023 Annual Conference Brochure - Flipbook - Page 17
SATURDAY, SEPTEMBER 30, 2023
BREAKOUT SESSIONS
TRACK 2:PEDIATRIC
RESEARCH
TRACK 3:ETHICS IN
RESEARCH
Time: 4:35 to 5:20
Track: Pediatric Research
Tales of a Pediatric Clinical Research Nurse - The
Lengths We Will Go to for High Quality Data
Ms. Roush will discuss ways research nurses can help
decrease protocol deviations and manage expectations
for all involved in the research. Helpful tips on ways to
promote adherence to pediatric protocols will be
provided as well as measures that nurses are willing to
do to get quality data and still ensure safety and
patient satisfaction. 231
Presenter: Kandice Roush, BSN, RN, CCRC, Clinical
Research Nurse & Team Leader, Nationwide Children's
Hospital
Time:11:40 to 12:25
Track: Ethics
Why Privacy is the Cornerstone of Trial Participant Trust
Rob Masson will discuss the most important issues North
American sponsors need to consider when collecting
personal data from EU & UK clinical trial participants.
The presentation will cover the impact of the Clinical
Trial Regulation, the introduction of the Clinical Trial
Information System, the need for oversight of your CRO
and trial partners, EU & UK representation requirements
and considerations for cross-border personal data
transfers. 323
Presenter: Rob Masson, Chief Executive Officer, The DPO
Centre
TRACK 3:MONITORING
Time:8:30 to 9:15
Track: Monitoring
CRA Best Practices
We will discuss best practices gained by a senior CRA
with over 20 years of experience. 317
Presenter: Aaron Chan, BA, Senior CRA, GSK
Time:9:20 to 10:05
Track: Monitoring
Remote Monitoring Challenges During the Midst of a
Pandemic
Ms. Mahanti will discuss how the world of clinical trial
monitoring faced challenges during this the COVID-19
pandemic. We will learn to do the best with limited
resources, yet maintain patient safety! 319
Presenter: Harshini Mahanti, MSc, CCRP, Clinical
Research Monitor, University of Miami
Time:10:50 to 11:35
Track: Monitoring
How a CRA Can Support a Study Site Before, During,
and After a Regulatory Inspection
It doesn't happen often in a CRA's career, but when it
does, it can induce panic like nothing else: the phone
call from your site announcing "The FDA is coming on
Monday." That is exactly what happened to me one
already busy day. After the initial panic (I may or may
not have hyperventilated), and with the support of my
company's quality department, I put together a plan to
effectively prepare my site for the inspection, support
the site during the inspection, and guide them in
responding to the 483 after the inspection. Saying that
my learning curve was steep is an understatement, but
the site and I survived and even became stronger
because of it. I am here now to share the steps you can
take when you get that phone call to cultivate a wellprepared site, a smooth inspection, and a stellar 483
response that results in a stronger site (and makes you a
stronger CRA). 321
Presenter: Wendy Upton, BA, RN, Senior CRA, PPD
SOCRA ANNUAL CONFERENCE BROCHURE
Time:1:40 to 2:25
Track: Ethics
Human Radiation Experiments in the United States:
History and Ethical Considerations
From the 1940s and into the 1970s, researchers exposed
human subjects to radiation, often without the
knowledge or consent of the subject. Study subject
selection and the use of vulnerable populations are also
ethical concerns in radiation studies. This talk will review
the history of radiation experiments in the United States
and the concepts of autonomy, beneficence, and justice
as it applies to research subjects. 325
Presenter: Annette Oeser, BS, MLAS, CCRP,
Clinical/Translational Research Coordinator III,
Vanderbilt University Medical Center
Time: 2:30 to 3:15
Track: Ethics
Eliminate Unconscious Bias Through a Better
Understanding of History
This riveting and insightful presentation is designed to
examine the early Indigenous inhabitants of the
Americas before the arrival of European settlers. In this
session, you will gain a deeper perspective concerning
the injustices that occurred during that time and take a
closer look at how Spain would emerge to define its
role. Discover the irrefutable facts about African people
and their past history that were purposely omitted as
part of the process to dehumanize indigenous then
African people. Develop a new “belief system” and truth
about ethnic groups that created large-scale organized
cities, kingdoms, and empires. Empower your leadership
team with a clearer perspective, promote a more
diverse workforce culture and remove undue fear and
discomfort about racism. All ethnic groups will be more
equipped with knowledge of inclusion after this life
changing presentation. 327
Presenter: Roger Persaud, RP Consulting Solutions, LLC
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