Endpoint by Design: SOA Workbench and Data Definition Specifications

About this session

Part of Session 2: CDISC Plenary - 360i Vision & Roadmap (Chair: Julie Smiley, CDISC).

Defining an endpoint begins long before data is collected — it starts in the protocol. This presentation demonstrates how the CDISC 360i SOA Workbench operationalizes study design as structured, machine-readable metadata, and traces how that intent flows forward into Data Definition Specifications (DDS) and Define-XML.
Using Progression-Free Survival as a running example, the presentation shows how a Schedule of Activities is built in USDM, how Biomedical Concepts are linked to visits and grouped into meaningful collections, and how Dataset Specializations and CRF Specializations capture the intended data collection structure at the point of design. From there, we show how that structured design becomes the foundation for automatically generating DDS artifacts — preserving the connection between what a protocol intended to collect and what the submission metadata describes.
Attendees will see a live demonstration of the SOA Workbench and gain a practical understanding of how connected, standards-based study design eliminates manual handoffs, reduces ambiguity, and creates a traceable thread from protocol endpoint to submission-ready data definitions.

Speaker

• DM

  Darren Moreland

  CDISC

  Speaker