November 2024 SOCRA Source Journal - Journal - Page 92
SOCRA Emergency Clinical Research Symposium
IN-PERSON
DECEMBER 5 & 6, 2024 | ORLANDO, FL
Workshop registration fee: $585 (Non-member $660 - includes one year’s membership)
Goal: The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education
for Clinical Research Professionals responsible for the activities at the research site or institution. The
purpose of this workshop is to assist Research Professionals in improving their skills and their understanding
of the responsibilities of conducting clinical research in the emergency setting. Conducting research in
the emergency setting presents unique challenges to clinical research professionals. Information will be
presented and discussed regarding the development, approval and administration of emergency clinical
trials according to regulation and guidance. The program will address hot topics such as the “challenges of
informed consent”, “funding potential for emergency research” and “design considerations for emergency
clinical research”.
Objective: The goal will be accomplished through lecture and practical application facilitated by clinical
research professionals. Information will be presented and discussed regarding the administration of clinical
trials according to FDA Regulations and International Conference on Harmonisation (ICH) regarding
emergency clinical research.
Learning Objectives - The attendee should be able to:
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Understand current regulations related to emergency research
Understand current challenges facing researchers conducting non therapeutic research in a pediatric emergency
department setting.
Discuss possible solutions to challenges to non therapeutic research in an emergency department setting.
Describe challenges in Emergency Medicine triage related to psychological and psychiatric behaviors of both
researchers and potential research participants.
Identify behavioral, psychological and psychiatric behavior strategies to address challenges and mitigate risk.
Discuss the process involved in emergency and expanded access use INDs.
Discuss site level structures, strategies and best practices for managing and administering a scalable, sustainable
research enterprise
Recognize ethical and regulatory considerations in emergency research with emergency and compassion use drugs.
Discuss special design considerations for adult emergency research studies including selection of study populations,
recruitment and retention of study subjects, outcome measures, assessment effects and ef昀椀cacy vs. effectiveness.
Discuss challenges associated with screening and recruitment in urgent and acute care settings.
Understand IRB requirements for emergency research as well as the process and requirements for exception from
informed consent in emergency research under CFR 21.50.24
Learn the practical aspects, pitfalls and approaches to obtaining pediatric informed consent and trial enrollment in
time-sensitive emergency settings and how to apply them.
SOCRA designates this educational activity for a maximum of 13 Continuing Education Credits
for SOCRA CE, Nurse CNE, and Physician CME.
SOCRA designates this live activity for a maximum of 13 AMA PRA Category 1 Credit(s)™.
Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing
Medical Education to provide continuing medical education for physicians.
CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing education by the
American Nurses Credentialing Center's Commission on Accreditation.
SOCRA Course Series 950
92
SOCRA SOURCE © November 2024
