2024 Annual Conference Brochure - Flipbook - Page 14
FRIDAY, SEPTEMBER 27, 2024
BREAKOUT SESSIONS
TRACK 7: SPANISH / ESPAÑOL
TRACK 8: MONITORING
Fri., Sept. 27 1:15 to 2:00
Track: Spanish Language
Trends in Phase I Clinical Trial Design
Dr. Garrido-Laguna will discuss the perspective of a
clinical investigator enrolling Spanish-speaking
participants. Special considerations required for these
participants will be reviewed. 709
Presenter: Ignacio Garrido-Laguna, PhD, MD, Phase I
Program Director, Huntsman Cancer Institute
Fri., Sept. 27 1:15 to 2:00
Track: Monitoring
Cinderella the new CRA and magical tips from the
fairy (Effective strategies for an entry level Clinical
Research Associate)
Ms. Mahanti will discuss what tools and resources new
clinical research monitors can use to make their lives
easier. 809
Presenter: Harshini Mahanti, MSc, CCRP, Senior Clinical
Research Monitor, University of Miami
Fri., Sept. 27 2:05 to 2:50
Track: Spanish Language
Investigator Oversight
Al firmar la forma 1572, el Investigador garantiza que de
manera personal conducirá /supervisará el estudio; sin
embargo, los investigadores no solo son responsables de
la calidad de los datos, también lo son de mantener la
credibilidad. Si los Investigadores actúan con integridad,
mantienen a su personal entrenado y mantienen la
adecuada supervisión del estudio, los centros de
investigación y patrocinadores tendrán resultados
satisfactorios con el subsecuente beneficio para los
pacientes. 711
Presenter: Jorge Cruz Gonzalez, MD, Regional Manager,
Alcon
Fri., Sept. 27 3:25 to 4:10
Track: Spanish Language
The Work of the Site Coordinator
Esta charla proporciona una visión general para que los
coordinadores de estudio tengan las herramientas
necesarias para comprender e implementar el protocolo
de investigación. Así como también, proporcionar
herramientas sobre cómo el CRC puede colaborar con
enrolamiento de pacientes en el estudio, la negociación
del presupuesto y la viabilidad del estudio en su centro.
713
Presenter: Julissa Alvarez, MD, EdD, CPH, Manager, Clinical
Research, Envision Healthcare Research Insitute
Fri., Sept. 27 4: 15 to 5:00
Track: Spanish Language
Roles del Monitoreo de Investigación y La Idea
Equivocada
El propósito de esta presentación es resumir todas las
diferentes visitas de monitoreo durante el curso de un
estudio clínico y la idea equivocada de que esto es todo
lo que hacen los monitores. 715
Presenter: Di Marcos Pereira, BS, MBA, CCRP, Clinical Site
Manager, Alcon
Fri., Sept. 27 2:05 to 2:50
Track: Monitoring
Monitoring Sponsor-Investigator Protocols: Lessons
Learned from FDA Inspections
Monitoring of clinical trials is a pivotal aspect of quality
control. Successful FDA inspections are often realized
due to robust monitoring practices targeting specific
components of subject protection, product management,
and regulatory affairs. 811
Presenter: Abby Statler, PhD, MPH, MA, CCRP, Director,
Research Quality and Safety, Dartmouth-Hitchcock Medical
Center
Fri., Sept. 27 3:25 to 4:10
Track: Monitoring
Optimizing Clinical Research Monitoring
Ms. Surdam will explore the nuances of central, remote,
and risk-based monitoring to highlight the similarities,
differences, and unique challenges of each. How to
unlock the full potential of each monitoring approach
individually and gain insight into the benefits of utilizing
several techniques concurrently to effectively enhance
monitoring strategies across the board will be discussed.
813
Presenter: Kristin Surdam, MS, PMP, CCRC, Senior Director,
KOL & Strategy, Florence Healthcare
Fri., Sept. 27 4: 15 to 5:00
Track: Monitoring
Inspection Readiness: Are You Ready?
Mr. Wise will consider practical and useful
recommendations on how to prepare for inspections and
ensure proper monitoring of investigations. Not simply
regurgitating the regulations but reading between the
lines to understand the 'why' and to make smart,
proactive choices throughout the clinical trial lifecycle.
815
Presenter: Andy Wise, BA, CCRC, CCRA, Associate Director,
Elevation GCP Consulting, LLC.
SPANISH SESSIONS
Offering sessions in Spanish marks a significant step
towards enhancing inclusivity, fostering greater
participation among our international members, and
ensuring accessibility for diverse trial stakeholders.
13
7