ADaM Validation Update from OpenCDISC

May 29, 2015

On March 24, 2015, CDISC published Version 1.3 of its ADaM Validation Rules. The release's main goal was to add new business rules for ADAE (Adverse Events) and BDS-TTE (Time-to-Event Analysis), and, at the same time, clean up some of the checks from the prior release.

But these new rules still don’t provide a complete solution. ADaM validation requires the ability to supplement the ADaM rules with sponsor-specific controlled terminology and value level checks ... and the ability to test those checks with the same software used by the FDA.

Through this webinar, we’ll provide an overview of recent changes and share our experience of the most common issues in ADaM submission data observed across the industry. Our speaker will be Pinnacle 21’s Michael DiGiantomasso. Mike serves on the CDISC’s ADaM Validation sub-team and is a Data Fitness Analyst on the FDA JumpStart project.

For your convenience, we’ll be providing this webinar at two different times.

WEBINAR SESSION 1 WEBINAR SESSION 2
Date: Wed, Jun 3, 2015
Time: 9:00 am EDT
(15:00 CEST)
Length: 1 hour
Date: Thu, Jun 4, 2015
Time: 2:00 pm EDT
(11:00 am PDT)
Length: 1 hour
Register Register

In this webinar, we will cover:

  • Review of all ADaM validation rules and categories
  • Overview of datasets recognized by OpenCDISC
  • Adding sponsor-specific CT and VLM checks
  • Common ADaM issues in submission data
  • Rules for the upcoming release of ADaM IG v1.1

Best regards.
OpenCDISC Team