New Jersey Chapter: The ABCs of Risk-Based Monitoring for Sites (ACRP 2025 Conference Replay Session)
This event will be presenting a replay sessions from the ACRP Conference Library
Event Description:
For more than a decade, multiple sources of regulatory guidance have increased their focus on risk management in clinical studies, paving the way for industry to adopt more risk-based monitoring strategies internationally. With the issuance of ICH E6(R3), an even more focused risk-based approach is expected. While Industry initially struggled to implement risk-based monitoring, moving review into central/remote scenarios as opposed to traditional onsite monitoring, we can now apply lessons learned to various indications and phases of research. We’ve come very far in tailoring systems and approaches to fit the needs of studies while still building in quality by design. Sites are important partners, but have been left out of the conversation about risk-based monitoring. Industry has fallen short in making risk-based monitoring something tangible to sites. Our goal is to bring sites a greater understanding of what sponsors/contract research organizations (CROs) are looking for, how they develop their key risk indicators, and how their ongoing monitoring and mitigation strategies impact their studies.
Speakers:
Sara Croteau and Valerie Paolella
Learning Objectives:
- Set the stage with definitions: risk management set up for a CRO/Sponsor and risk-based monitoring
- Understanding what are Key Risk Indicators (KRIs)
- Impact of RBM for a site
Registration & ACRP Contact Hour Information:
- NJ Chapter Member (registration with or without contact hour): $0
- Other Chapter Member (registration with or without contact hour): $5
- ACRP Member (registration only): $5
- ACRP Member (registration + contact hour): $20
- Non-Member (registration only): $10
- Non-Member (registration + contact hour): $85
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.