It’s no surprise: the FDA continuously trains its investigators on how to conduct data integrity inspections. The result is inspectors who cite a significant number of data integrity observations during inspections, taking action against companies that commit data fraud or provide false information.
Making matters worse, investors and business partners are getting into the act: they’re filing multimillion-dollar class-action lawsuits against firms that misrepresented their compliance with FDA requirements.
Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges is an interactive virtual workshop that will give you the tools you need to ensure your clinical trials’ electronic records are trustworthy and reliable across their entire data lifecycle, from initial data creation through long-term archives.
This webinar will explain complex FDA data integrity regulations in simple “what to do, how to do it” language using real-world examples and offering practical advice you can follow.
Virtual Workshop Takeaways:
How to apply the elements of data integrity characteristics — attributable, legible, contemporaneous, original and accurate (ALCOA+) — to real-world clinical development, trial conduct and post-trial analysis
An exploration of overlooked guidance documents that can help define expectations (including what the FDA and the European Medicines Agency inspect for and why)