Date and Time:
TUE, 28 APR 2020, 9:00 AM - 12:00 PM Eastern US Standard Time
Description:
Your first look at CDISC 360 use cases and the ongoing development of standards-based metadata-driven automation concepts.
CDISC 360: The Journey so Far and the Road Ahead
Peter Van Reusel, CDISC
An exclusive look at the ongoing development of CDISC 360 including the project definition, its approach, the current progress and the road ahead. It will include an “Art of the Possible” User Experience (UX) presentation that walks attendees through a possible future-state system that selects the standard concepts needed for a study from the CDISC Library as linked metadata, based upon an identified study endpoint.
What Is CDISC 360: an enterprise architecture perspective
Dr. Sam Hume, CDISC and Tianna Umann (Microsoft)
This presentation breaks down the CDISC 360 project implementation into the following layers to view the work from a number of different perspectives without getting deep into the technical details: Business, Data, Applications, and Technology. Attendees have the opportunity to learn about how we’re applying technology to demonstrate the CDISC 360 ideas, including topics such as the models that represent new content, the metadata that drives data transformations and derivations, the wide array of software applications driving the automation, and cloud architectures.
Study Design and Configuration using CDISC 360 concept-based standards
Mikkel Traun (Novo Nordisk), Nicolas De Saint Jorre (XClinical)
In Use Case 1 and 2 we develop a prototype for how a study specification can be made using the CDISC 360 concept-based standards. This presentation demonstrates how this can be achieved through a study metadata library implemented in a link graph database, by the use of a Study Designer App prototype. (Use case 1 & 2)
Automation of SDTM Generation & Artifacts using CDISC 360 enriched standards
Bhavin Busa (Vita Data Sciences), Jianhua [Jimmy] Zhao (Allergan)
This presentation will demonstrate the use of CDISC 360 enriched standards-based metadata to drive automation for generation of SDTM domains and associated submission artifacts. We will review the process of consuming study specifications artefacts and look at the configured metadata structure that is driving end-to-end automation. (Use case 3)
Automation of ADaM & TLF Generation using CDISC 360 enriched standards
Bhavin Busa (Vita Data Sciences), Prasanna Murugesan (AstraZeneca)
This presentation will demonstrate the use of CDISC 360 enriched standards-based metadata to drive automation for generation of analysis datasets (ADaM) and study TLFs. The demo will focus on generation of analyses outputs and associated SAS codes via a R-Shiny interactive interface and available TFL metadata schema (enriched Analysis Result Metadata) and templates. (Use case 3)