When CDISC published Version 1.3 of its ADaM Validation Rules, a lot of you wondered what to make of it.
According to CDISC: “Some checks have been reworded for clarification … [and] 75 new checks have been added to cover rules not previously addressed. [These] additional checks cover the addition of checks for Adverse Events (ADAE) and the ADaM Basic Data Structure for Time-to-Event Analyses (BDS-TTE).”
To paint a clear picture of what all this means, and how the industry should respond, Pinnacle 21 hosted a recent webinar on this topic. The webinar — titled, “ADaM Validation Update from OpenCDISC” — provided an overview of these changes, and shared our experience of the most common issues in ADaM submission data observed across the industry.
The speaker was Pinnacle 21’s very own Michael DiGiantomasso, who serves on the CDISC’s ADaM Validation sub-team and is a Data Fitness Analyst on the FDA JumpStart project. In addition to the aforementioned, Michael also covered the datasets recognized by OpenCDISC software, guided a deep dive into the various ADaM validation categories, and provided an overview of the rules for the upcoming release of ADaM IG v1.1. Perhaps most importantly, Michael covered how you can add sponsor-specific controlled terminology and value level checks. This, of course, is critical for ADaM validation — yet was not well-informed by CDISC’s documentation.
Which is where we come in. As the FDA continues its mission toward standardized study data, we at Pinnacle 21 will continue to support our industry with information, tools and services that can help enable and accelerate the FDA approval process.
Initial feedback on the webinar has been very positive. If you missed it, no matter. Below, you’ll find links to the webinar video and PPT deck, as well as the Q&A that followed. Download and review them as you like. And, if you have any specific questions pertaining to the new checks and/or ADaM validation, please contact us.