CDISC 360

What is 360?

360 is the CDISC initiative aimed at implementing standards as linked metadata with a conceptual foundation providing the additional semantics needed to support metadata driven-automation across the end-to-end clinical research data lifecycle.

New software tools will be able to consume this new metadata to ease standards implementations while increasing data processing efficiencies.

Standards-based metadata-driven automation is a critical component in realizing the primary benefits expected of the CDISC standards: substantially improved efficiency, consistency, and re-usability across the clinical research data lifecycle.

These benefits drive the return on investment in the CDISC standards implementations expected by CDISC stakeholders.

April 2021 - EU Virtual Interchange

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October 2020 - US virtual Interchange

Project evaluation – Stage 3

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March 2020 - October 2020 - Stage 3: “Bringing the work together”

Developed metadata content per concept model and flowed to sandbox library

Flowed metadata across the use cases

Auto-generated study metadata and data artifacts


April 2020 - 2020 EU Virtual Interchange

Project evaluation – Stage 2

Refined scope deliverables

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October 2019 - March 2020 - Stage 2: “Team maturation; deeper substance development”

Changed emphasis from workstream to task-team centric

Matured concept model

Tooling to process concept-based standards metadata to auto-create study artifacts


October 2019 - 2019 US Interchange (San Diego)

Project evaluation – Stage 1

Next 6-month plan

CDISC 360: Preparing for a Bright Future

CDISC 360 Update: Evolution of the CDISC Standards

CDISC Library: Integrating and Surfacing 360 Content

CDISC 360: Art of the Possible Initial Concepts

CDISC 360 Use Cases -Industry Perspectives Workstream 4 -DEFINE Use Case 1: End to Start Standards Specification

CDISC 360 Use Cases: Industry Perspectives Workstream 5 -Build(Use Case 2) Configure study specification and create artifacts

CDISC 360 Use Cases -Industry Perspectives Use Case 3 (Workstream 6): Automated Data Processing

May 2019 - Oct 2019 - Stage 1: “Workstream organization; Moving up the learning curve”

Workstream-centric activities

Workstream logistics and early substance development

Established collaboration technology platform


 

The CDISC 360 White Paper describes the output of the CDISC 360 Proof of Concept as well as the technical prototypes developed using CDISC standards as linked metadata. The CDISC 360 standards content provides the additional semantics needed to support metadata-driven automation across the end-to-end clinical research data lifecycle.

CDISC 360 White Paper