Emergency Clinical Research Symposium
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.
The participant will be able to:
- 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 efficacy 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.