A2.1 Exploring the Transition from CDISC Define-XML 2.0 to 2.1

This presentation is part of a full breakout session. To add this presentation to your schedule you must add the full breakout session.

The Define-XML is an autodidact that resembles the data structure and content during clinical trial process. Now, a time to evolve with the fundamental components and choose the efficient approaches in the path to move forward in the studies with the electronic submission of Define-XML 2.1. This presentation aims to analyze the additional checks underlying the Define and explain the possible impacts on progress from 2.0 to 2.1.

The number of actual checks is considered for the audience whose prior experience is minimal to moderate in CDISC existing processes. The paper’s guidance is about the advancements in the regulatory standards and producing the best quality of the define.xml file with proper hold of assumptions and results. 

The switch between Define-XML standards was significant since the datasets with no data collection could not be interpreted as empty datasets in version 2.0. However, the attribute introduced in the latest published version 2.1 aids in displaying empty datasets with no observations. The implementation of this shift was strong enough to raise in the industry for our submission and knowledge of standards among sponsors. The controlled terminology and standards used are few of the impactful advantages in the upgraded version 2.1 that will be summarized. In addition, the tips, and tricks to resolve the common issues in CDISC Define-XML 2.1 triggered by Pinnacle 21 Enterprise which would not be there in version 2.0 will be addressed in detail to fix before submission.

The implemented elements analyzed, substantiate the additional checkpoints with a focus on impact of data quality and industry standards recommended by the FDA for the studies after March 2023 in the newer version. Consequently, the elements and attributes of 2.1 make it more acceptable and accountable among sponsors. We look forward to presenting and discussing Define-XML Version 2.1 at the conference, highlighting the efficiency of additional checks and interoperability results of standards across our industry.