Colorado Chapter: Detecting and Addressing the Quality Pitfalls at Study Sites (ACRP 2025 Conference Replay)
This event will be presenting a session replay from the ACRP Conference Library
Event Description:
How can sites decrease the most common non-compliance issues cited in regulatory inspections? The types and frequency of these findings have not changed significantly in the past decade. With increasing complexity in research protocols, quality remains a concern to regulatory authorities. While monitors play a significant role in ensuring site performance and compliance, U.S. Food and Drug Administration notices place the onus on site personnel. In this presentation, we will highlight areas of deficiencies seen over many years at investigator sites. We will also discuss common inspection findings and how to spot the pitfalls that sites need to address in order to ensure compliance in conduct, performance, and overall execution of clinical trials.
Speakers:
Jerry M. Stein, PhD, ACRP-CP, ACRP-MDP, FACRP
President
Summer Creek Consulting, LLC
Suheila Abdul-Karrim, RQAP-GCP, CCRA, FACRP
Clinical Research Consultant
Auditor and Trainer
Event Agenda:
- 4:45 – 5:00 pm – Registration and sign-in
- 5:00 – 6:00 pm – Presentation
- 6:00 – 6:15 pm – Q&A
Learning Objectives:
1. Increase the awareness of site personnel for the structure and function of clinical protocols developed by sponsors
2. Identify the issues with protocols that typically contribute to noncompliance
3. Present recommendations for sites and sponsors that can lead to improvements in compliance and efficiency
Registration & ACRP Contact Hour Information:
- Chapter Member (registration with or without contact hours): $0
- ACRP Member (registration only): $0
- ACRP Member (registration + contact hours): $15
- Non-Member (registration only): $0
- Non-Member (registration + contact hours): $30
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