West Virginia Chapter: Cautionary Tales from the Front Lines of Clinical Trials (ACRP 2025 Conference Replay)
This event will be presenting a conference replay session from the ACRP 2025
Event Description:
Numerous clinical trial failures are traced by the U.S. Food and Drug Administration back to inadequate oversight by principal investigators (PIs). This session delves into real-world examples of such failures, highlighting the threats posed to participant safety and trial integrity. We will explore key focus areas, including the qualifications of delegated individuals, adequacy of training, requirements for continuous supervision, and provisions for third-party oversight. Attendees will learn how to avoid common pitfalls and enhance PIs' knowledge to ensure trial success. Additionally, we will discuss the practical application of risk-based quality management, the ongoing debate on the necessity of monitoring, and the impact of training deficits. This session is essential for clinical research professionals aiming to support PIs and uphold the integrity of clinical trials.
Speakers:
Suzanne Kincaid, Jerry Stein, Jeri Burr
Learning Objectives:
- Understand how lack of PI oversight can destroy a clinical trial.
- Apply best practices in escalating findings of non-compliance.
- Discuss preventative actions intended to decrease the incidence of noncompliance.
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
After registering, please visit the event's community page to find the login information or any additional event updates, and to communicate with the event organizer.
To claim contact hours: Register and purchase the contact hours and attend the event. After attending the event, visit learning.acrpnet.org and log into your ACRP account. Click the “GO TO MY COURSES” box. Find the event in your dashboard, confirm your attendance, and take the event evaluation between 1 and 30 days following the event to obtain the online certificate. After 30 days, contact hours are no longer available.