SOCRA 2024 Annual Conference Program Book - Flipbook - Page 41
SATURDAY, SEPTEMBER 28, 2024
BREAKOUT SESSIONS
TRACK 5: INVESTIGATOR-INITIATED
RESEARCH
PAVILION 11
TRACK 5: INVESTIGATOR-INITIATED
RESEARCH
PAVILION 11
Moderator: Nancy Wintering, MSW, LCSW, CCRP
Moderator: Nancy Wintering, MSW, LCSW, CCRP
Sat., Sept 28 8:30 to 9:15
Track: IIR
Close Out Phase of a Clinical Research Study
The close out stage is labor intensive and requires all
functional areas to work collaboratively to ensure a timely
and effective close out. Ms. Baker will describe the steps
to close a study, what functional areas are involved and
what actions are needed for the IRB as well as data
review, regulatory review, safety review, and statistical
review. 517
Presenter: Layla Baker, MBChB, MPH, CCRP, Senior Clinical
Research Manager, Elevance Health/ Carelon Research
Sat., Sept 28 11:40 to 12:25
Track: IIR
What9s Drugs Got to Do With It? Using Supplements
and Vitamins as Drugs
What do we need to know about conducting Investigator
Initiated Research with Supplements and Nutrients as
pharmaceuticals? The prevalence and use of vitamins
and supplements continues to rise. Ms. Wintering will
discuss considerations when using supplements for selfcare or as a test article in clinical research. Is
Investigational New Drug application with FDA oversight
required? Understanding the mechanism, clinical effect,
optimal dosing, and side effects/drug interactions of all
nutrients and supplements should be a primary goal of
research. When participants use supplements regularly,
what are the implications for safety in clinical research
that uses other drugs? Ms. Wintering will discuss
controversy and ethical considerations when using
vitamins and supplements as pharmaceuticals. Case
examples will be presented. 523
Presenter: Nancy Wintering, MSW, LCSW, CCRP, Assistant
Director of Research, Thomas Jefferson University
Sat., Sept 28 9:20 to 10:05
Track: IIR
Investigator Initiated Trials in an Academic Setting
Ms. Rajakumaran will consider the process of how the
Centre for Clinical Trial Support functions as a study
coordinating centre in managing multi-centre Investigator
Initiated trials. This includes, study intake, study start-up
activities, getting sites activated, providing ongoing
support to participating sites, data management,
monitoring, regulatory submissions, and close-out. 519
Presenter: Subitha Rajakumaran, BSc, CCRP, Senior Project
Manager, Trials Operations, Sunnybrook Research Institute
Sat., Sept 28 10:50 to 11:35
Track:IIR
Challenges Implementing Centralized Monitoring for
Multi-Center Investigator-Initiated Trials at an
Academic Medical Center
Ms. Reid will delve into the intricate journey of
implementing a centralized monitoring approach at a
large oncology academic medical center and explore the
multifaceted challenges faced during the development
phase. This session aims to provide an overview of the
hurdles, focusing on data integrity, communication,
standardization, regulatory compliance, site coordination,
training, and technology integration. 521
Presenter: Rebecca Reid, BS, CCRA, Senior Clinical Research
Monitor, University of Miami
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Sat., Sept 28 1:40 to 2:25
Track: IIR
How to Conduct IND and IDE Studies - From a Sponsor
Perspective
Investigators with a novel study idea may require an
Investigational New Drug Application or Investigational
Device Exemption application. A sponsor9s responsibility
is to assist investigators and study teams with every step
of this process. 525
Presenter: Laura Adkins, MAP, BA, CCRP, CCRA, CRS, AdvCRS,
Director, Office of Research Regulatory Affairs, University of
Arkansas for Medical Sciences
Sat., Sept 28 2:30 to 3:15
Track: IIR
How to Effectively Train a Sponsor-Investigator
Sponsor-Investigators are often unaware of the complete
set of responsibilities they assume when taking on this
dual role. Dr. Statler will provide training strategies and
curriculum content intended to support the development
of such education. 527
Presenter: Abby Statler, PhD, MPH, MA, CCRP, Director,
Research Quality and Safety, Dartmouth-Hitchcock Medical
Center
