SOCRA 2023 Annual Conference Brochure - Flipbook - Page 12
FRIDAY, SEPTEMBER 29, 2023
BREAKOUT SESSIONS
TRACK 3: INVESTIGATORINITIATED RESEARCH
Time: 3:25 to 4:10
Track: IIR
Investigator-Initiated Research: From Start to Audit
Ms. Weidler will discuss the processes for investigatorinitiated research protocol development and launch and
discuss the perspective of a sponsor-investigator for an
FDA audit. The experience of being a 100% electronic
study for a 14-site NIH U-grant project will be
presented. 313
Presenter: Erica Weidler, MEd, MA, CCRC, Research
Associate/Assistant Professor, Phoenix Children's
Hospital
Time: 4:15 to 5:00
Track: IIR
Trials and Tribulations: Auditing and Monitoring
Investigator Initiated Trials (IITs)
Investigator Initiated Trials (IITs) present unique
regulatory and operational challenges and risks.
Specialized skills and knowledge are required for
implementing internal monitoring and auditing programs
in order to achieve compliance leading to successful
trial execution. This session will share monitoring and
auditing programmatic plans and techniques to address
the challenges of IITs as well as lessons learned and
successes 315
Presenter: Wendy Portier, MSN, RN, CHRC, CHC,
Consultant, Portier & Associates, LLC
Cynthia Dunn, MSN, CCRP, RN, CCRA, Clinical Research
Consultant, Crescent City Research Consulting LLC
TRACK 4:REGULATORY /
LEGAL
Time: 1:15 to 2:00
Track: Regulatory / Legal
Why Boilerplate Clauses in Clinical Trial Agreements
Matter
CTA negotiations are often long, time-consuming, and
costly. As a result, many sites simply chose to ignore the
boilerplate clauses such as governing law, venue,
assignment, survival, force majeure, and others. This can
unnecessarily expose the site, the PI, and all study
personnel to serious financial risk. This presentation will
help identify and describe the key boilerplate clauses in
CTAs and will then provide the attendees with
suggestions of how to negotiate these clauses in a
proper and efficient manner. 409
Presenter: Marlon Rajakaruna, BA, MBA, LLB, CRCP,
Lawyer, Kingsgate Legal
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TRACK 4:REGULATORY /
LEGAL
Time: 2:05 to 2:50
Track: Regulatory / Legal
How to Assess Adverse Event Causality in a Clinical
Trial
There have been numerous methodological publications
for assessing causality in adverse events. The Bradford
Hill Criteria is one of the most practical and easy to
implement. This presentation will discuss the diverse
options for assessing causality and present a pragmatic
approach to this important task. 411
Presenter: Gerald Klein, MD, Principal, MedSurgPI LLC
Time: 3:25 to 4:10
Track: Regulatory / Legal
The Difference is in the Details – Drug vs. Device Trials:
A Regulatory Perspective
Overview of FDA regulatory requirements for INDs and
IDEs is presented as a side-by-side comparison, based
on the experience of working mostly with investigatorinitiated clinical trials. Drug and device trials have
differences. One unarguable similarity they have in
common: Patients. Regulations are in place to ensure a
well-controlled, properly and ethically run clinical trial,
and the patients’ safety. 413
Presenter: Felicia Nica, MD, MS, MBA, CCRP, RAC,
Administrative Director, Clinical Research, MD Anderson
Cancer Center
Time:4:15 to 5:00
Track: Regulatory / Legal
Overview of Regulatory Requirements of the
ClinicalTrials.gov Registration and Results Reporting
(PRS) System
The ClinicalTrials.gov Protocol Registration and Results
System (PRS) database is the largest national registry of
clinical trials and contains data from studies conducted
across the world. Attendees will learn why, when, and
how to register Clinical Trials in the PRS. Additionally,
they will understand how to report the results of their
studies in the system. This session is aimed at clinical
research team members seeking to learn more about the
importance of the regulatory requirements of the
ClinicalTrials.gov system. 415
Presenter: Susan Hmwe, PhD, MS, MBBS, CCRP, Manager,
Clinical Research Data Quality & Reporting, City of
Hope Comprehensive Cancer Center