May 2015

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

NJ CDISC UG meeting June 17 -- call for presentations

May 22, 2015

The next meeting of the NJ CDISC Users Group will be held the afternoon of June 17, 2015 at Medidata in NYC.
 
If you are interested in presenting at the meeting, please contact Patricia Majcher by Friday, May 22, 2015.  Presentations should be no more than 20 minutes long (excluding time for Q&A).  Any CDISC-related topic is welcome.  We look forward to hearing from you!
 
Here is the link for online registration; registration closes Friday, June 5:  https://www.survey-expert.com/web/surveyIndex.asp?U=0001005008105033328
Please note that teleconferencing will not be available for this meeting.
 
The final agenda will be posted about 1-2 weeks prior to the meeting, and instructions for attending the meeting will be emailed to registered attendees about 1 week prior to the meeting.