Webinar: Masters Classes in - Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges When: Thursday May 20, 2021 - 11:00 AM Duration: 8 Hours.
Is the FDA’s increasing scrutiny on your clinical trials’ data integrity giving you a data migraine?
FDA data integrity requirements are among the most stringent within regulated industries, so compliance is quite the challenge. Unless you establish internal competency and assessment programs, you can expect 483s and warning letters to come rolling in.
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.
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)
How to deal with suppliers, including data integrity chain-of-custody in the clinical space, typical clinical supplier red flags that FDA and other regulatory health agencies look for and dealing with critical suppliers that collect, handle and store clinical digital data… but are not regulated
What, where, how and why to document your data integrity controls and institute a risk-based approach, including monitoring data integrity controls with contract research organizations (CROs) and investigator sites.