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.

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.

It will be led by award-winning FDA compliance expert, author and Cerulean Associates founder, John Avellanet. He explains complex data integrity requirements in simple “what to do, how to do it, and why” language using real-world examples and offering practical advice you can follow. A former FDA and Department of Justice prosecutor calls Mr. Avellanet, “The best in the business. Period.”

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
  • Considerations regarding emerging issues: long-term archival storage, cloud-based technologies, wearables data and patient-submitted digital data; plus, the impact of inspectional changes in the clinical arena
  • What you must know about GCP data integrity enforcement, using real-world examples and statistics from regulatory agencies and providing recent updates to FDA’s pre-approval inspection (PAI) methods
  • Takeaways regarding both on-site and remote clinical digital data inspections, with questions and tactics you must be prepared to handle
  • The risks of true and certified copies with digital records, from the basics of true/certified copy and legal admissibility, to true-copy requirements from submission guidances and putting together a true-copy scanning process for clinical trial usage
  • How to prepare for and handle GCP data integrity: address challenges with remote inspection handling, perform sponsor-specific and CRO-specific activities, points to remember when responding to allegations of untrustworthy data and more

No more data migraines. You can avoid the data integrity 483s and warning letters while compliantly managing your clinical trials’ essential data — without it overwhelming you.

Who Will Benefit

  • Regulatory, Quality and Compliance Specialists
  • Clinical Trial Developers and Clinical Study Data Experts
  • Vice Presidents, Strategic Planning
  • Medical Product Attorneys
  • Drug and Device Consultants