Colorado Chapter: Two Steps Forward, One Step Back - Getting Ahead of Tech-Related Data Integrity Challenges (ACRP 2024 Webinar Replay)
This event will be presenting a webinar replay from the ACRP Conference Library
Event Description:
U.S. Food and Drug Administration (FDA) Investigators have uncovered data integrity issues related to electronic data in clinical trials, resulting in regulatory actions and/or FDA withholding of approval. This presentation will provide insight into electronic data on efficacy and safety and some real-world examples of questionable validity that the FDA has seen recently.
Event Agenda:
4:45 – 5:00 p.m. – Registration and sign-in
5:00 – 6:00 p.m. – Presentation
6:00 – 6:15 p.m. – Q&A
Learning Objectives:
- Review of FDA’s policies and guidance with technology use in clinical trials.
- Provide an overview of efficacy and safety data obtained via electronic means.
- Provide three real world examples in which efficacy/safety data validity was called into question based on FDA’s inspections.
Registration Information:
Please email Laurie.Burnside@outlook.com at least 24 hours in advance of the event to register.
Contact Hour Information:
- Chapter Members: $15.00
- ACRP Members: $15.00
- Non-Members: $30.00
To receive contact hours: Purchase the contact hours and attend the program. After attending the event, log on to the ACRP website and visit learning.acrpnet.org, click “GO TO MY COURSE”. Select your event, confirm attendance and take the event evaluation between 1 and 30 days following the event and obtain the online certificate." After 30 days, contact hours are no longer available