North Texas Chapter: Two Steps Forward, One Step Back: Getting Ahead of Tech-Related Data Integrity Challenges (ACRP 2024 Conference Replay)
This event will be presenting a session 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.
Speakers:
Craig Garmendia, PhD, MS, Investigator, International Inspection Cadre, U.S. Food and Drug Administration
Event Agenda:
11:45 : Log in
12:00 - 1:00 : Video Replay
Learning Objectives:
- Identify data integrity issues related to electronic data in clinical trials
- Explore some real-world examples of questionable data validity
Registration & Contact Hour Information:
- Chapter Members (registration with or without contact hours): $0
- ACRP Members (registration only):
- ACRP Members (registration + contact hours): $15
- Non-Members (registration only): $0
- Non-Members (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 program. After attending the event, log on to the ACRP website and visit learning.acrpnet.org, click “ACCESS ON DEMAND CONTENT”. Find the event in your dashboard, 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.