From Fragmentation to Interoperability: The Digital DTA Transformation

About this session

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

Once a study endpoint is defined and its data collection structure specified, a critical question arises: how does that intent transfer — faithfully and unambiguously — to the teams and systems responsible for execution? The Digital Data Transfer Agreement (DTA) addresses this challenge by providing a machine-readable, standards-based mechanism for communicating what data is expected, in what form, and traceable to what endpoint.
This presentation describes how the DTA fits within the CDISC 360i end-to-end framework, picking up where the Data Definition Specification leaves off and preparing structured data for downstream analysis. Using Progression-Free Survival as the running example, we demonstrate how a DTA captures data transfer expectations in a computable format — preserving the endpoint's original study intent, reducing ambiguity at the sponsor-CRO or sponsor-site interface, and enabling automated validation at the point of receipt.
Attendees will gain a practical understanding of how the DTA transforms a traditionally manual, document-driven handoff into a connected, traceable step in the Journey of an Endpoint — one that supports automation, reduces rework, and strengthens the integrity of data flowing into clinical analysis.

Speaker

• VS

  Valerie Sheft

  Merck

  Speaker