SOCRA 2024 Annual Conference Program Book - Flipbook - Page 38
SATURDAY, SEPTEMBER 28, 2024
BREAKOUT SESSIONS
TRACK 2: DEVICE
PAVILION 1
TRACK 2: DECENTRALIZED CLINICAL TRIALS PAVILION 1
Moderator: Kathi Durdon, MA, CCRP
Moderator: Jennifer Li, BSc, CCRP
Sat., Sept 28 8:30 to 9:15
Track: Device Research
Medical Device Clinical Research Risk Determination
Ms. Headlee will consider the risk classifications for
medical device clinical research (Exempt, NSR and SR).
She will also facilitate a discussion of helpful tips and
best practices for navigating the IDE pathway. 217
Presenter: Donna Headlee, BSN, RN, CCRP, Recently Retired
Branch Chief, FDA, CDRH, OCE, DICE, PPB
Sat., Sept 28 1:40 to 2:25
Track: DCT
Role of the HRPP in the Assessment of Decentralized
Clinical Trials
Ms. Coleman will discuss and provide an overview of the
role of the human research protection program to assist
in the assessment of Decentralized Trials. The
presentation will share possible models for leveraging
the HRPP for assessing DCTs and discuss case studies
and lessons learned regarding the role of the HRPP in the
review of DCTs. 225
Presenter: Linda Coleman, JD, CIP, CHC, CHRC, CCEP-I,
Director, Human Research Protection Program, Yale
University
Sat., Sept 28 9:20 to 10:05
Track: Device Research
Artificial Intelligence/Machine Learning in Medical
Device Studies
More and more investigational devices now have AI/ML
algorithms embedded in them. In this session, Ms.
Norman will discuss the basic of AI/ML in medical devices
and how FDA is requiring clinical studies to be designed,
as well as the operational challenges that are presented
to sponsors and clinical sites due to these study designs.
219
Presenter: Dawn Norman, MS, Partner, MRC Global
Sat., Sept 28 10:50 to 11:35
Track: Device Research
Points to Consider for Medical Devices and
ClinicalTrials.gov
Attendees will consider the rationale behind the
requirements of study registration, discuss the unique
requirements and considerations for medical devices and
ClinicalTrials.gov registration. Ms. Ferrazzano Yaussy will
also review the agencies requiring registration and
requirements for clinical trials involving medical devices.
221
Presenter: Cristina Ferrazzano Yaussy, MPH, CCRP, Research
Regulatory Affairs Specialist, Dartmouth-Hitchcock Medical
Center
Sat., Sept 28 11:40 to 12:25
Track: Device Research
Looking through the Medical Device Sponsor9s Lens:
Practical tools for assessing Lessons Learned and
How to Operationalize for Future Studies
What happens when the research study is finally closed,
and the study result is published or maybe not? Many
times, Project Managers come out of this process with
lots of bruises and blacklisted sites or shoutouts and
stellar sites. While this is good to know, this knowledge
alone is not enough. Ms. Annan will discuss how to use
effective tools to assess sites and investigator
performances after study closure and how to
operationalize the lessons learned for future studies
based on a 5-year global medical device studies for
about 500 subjects across 50 sites. 223
Presenter: Gladys Annan, MBA, BA, CCRP, PMP, Senior
Manager, Clinical Research, STERIS Endoscopy
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Sat., Sept 28 2:30 to 3:15
Track: DCT
The ABCs and GCP of Successfully Implementing
Decentralized Trials
In May 2023, the FDA issued draft guidance for
decentralized clinical trials. Initially embraced as a
means to adapt to lockdown conditions during the
pandemic, the benefits of remote clinical trial models,
including greater operational flexibility, access to diverse
populations of study participants, and cost savings are
now widely accepted. However, as sites have more
opportunities to participate in decentralized trials it is
important to be cognizant of the potential GCP risks and
measures sites can take to ensure participant rights,
safety, and data integrity. 227
Presenter: Lisa Harewood, CCRP, Senior Clinical Trials
Regulatory Specialist, Hope Clinic of Emory Vaccine Center
Sat., Sept 28 3:45 to 4:30
Rolling out DCTs: CRA Monitoring Considerations
Decentralized clinical trials offer many opportunities to
increase and possibly diversify clinical trial enrollment.
With those opportunities come additional CRA/monitor
responsibilities related to site assessments, site staff
training and coaching, and process and data verification,
among others. The speaker will discuss how
decentralized trials impact the CRA/monitor. 229
Presenter: Carolyn Rugloski, MSc, CCRP, Senior
Consultant, Lead Project Manager, FCI Consultants
Sat., Sept 28 4:35 to 5:20
Track: DCT
Clinical Research in Functional Medicine
Mr. Wehage will discuss the perspectives of a very rural
community that has been involved with clinical trials for
about eight years. 231
Presenter: Scott Wehage, MS, CCRP, Director, Clinical Trials
