Date: December 11th 2024
Time: 12 PM CDT (1 PM EDT)
Location: Connect via Zoom: https://ttuhsc.zoom.us/j/95874325749
Meeting ID: 958 7432 5749
Title / Topic: Embracing Clinical Research Audit and Inspection Readiness: Preparing for Success
Speaker: Jessica Rowe, MA, MS, CCRP, CIP
Quality and Education Director
Yale Cancer Center, Clinical Trials Office
Overview: Maintaining compliance, ensuring the integrity of data, and protection of human subjects are paramount for success in today’s clinical research landscape. This presentation delves into the essential strategies and best practices to achieve audit and inspection readiness in clinical research. Attendees will gain insights into the preparation, management of audit and inspection from notification to follow-up, and the importance proactive risk management.
Real-world case studies will be discussed to illustrate the practical application of these strategies, ensuring that clinical research teams are well-prepared for both internal and external audits and inspections. Additionally, we will explore methods for successfully navigating audit/inspection processes, which can significantly reduce team stress and improve overall efficiency. This presentation aims to equip clinical research professionals with the knowledge and tools needed to uphold regulatory compliance, enhance the credibility of their research initiatives, and foster a less stressful, more effective work environment during audit and inspection periods.
Learning Objectives:
• Understand the importance of the role of audit readiness in the credibility and effectiveness of research initiatives
• Discuss best practices for managing the audit and inspection process
Continuing Education (CE): SOCRA members may claim 1.0 CE credit per hour of education and will receive Certificates of Attendance at the completion of the event.
Contact and Questions: Mariana Fiori, PhD, CCRC, (806)743-3896, mariana.fiori@ttuhsc.edu
All SOCRA members and non-SOCRA members are welcomed
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