On March 24, 2015, CDISC published Version 1.3 of its ADaM Validation Rules.
So, what’s changed?
In the simplest terms: the release’s biggest enhancement is the ability to recognize and validate ADAE (Adverse Event Analysis) and BDS-TTE (Time-to-Event Analysis) datasets. CDISC has added 75 new rules in total, and, at the same time, cleaned up some of the checks from the prior release to ensure that their failure criteria is machine-testable.
So, what should concern you?
These published business rules conform to the definition of CDISC’s intention that each rule requirement be broken down into its constituent parts and should be machine-testable. For example, a simple rule which states “C BETWEEN A and B” will be stated as C >= A and C<=B. This normalized model works for business requirement capture … but it can make implementation, testing and human understanding more complicated than they need to be.
Beyond that, these newly enhanced ADaM validation rules still don’t provide a complete solution. Since ADaM IG v1.0, CDISC has been providing mere specifications documents. ADaM validation requires more than that. You need the ability to supplement the ADaM rules with sponsor-specific checks, especially for sponsor defined controlled terminology and value level metadata. And you need to be able to test those checks with the same software used by the FDA.
Pinnacle 21 is here to help.
On June 3rd and 4th, we’ll be hosting a webinar in which we’ll provide an overview of recent changes to CDISC ADaM Validation Rules and clarify exactly what you need to know. We’ll also show you how to add sponsor-specific checks using OpenCDISC Enterprise. Specifically, we’ll demonstrate how Enterprise’s Define.xml Designer can be used to define custom terminology and value level metadata. If you’d like to learn how to do this yourself — and not be at the mercy of expensive consultants — register for the webinar now.
ADaM’s purpose, lest we forget, is to provide analysis-ready data that gets you “1 proc away.” So these new checks should be welcomed as part of an ongoing, evolutionary movement in that direction. It’s important that you get the full picture. Pinnacle 21 will show you how to leverage the new checks to your full advantage. We’ll also share our experience of the most common issues in ADaM submission data observed across the industry and help you position yourself for better FDA submission readiness.
In the meantime, if you have a question regarding the new ADaM validation checks and how to manage them, don’t hesitate to send us an email.