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 - Europe Virtual Interchange

October 2020 - US Virtual Interchange

Stage 3: Project Evaluation

May 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 - EU Virtual Interchange

Stage 2: Project Evaluation - Refined Scope Deliverables

October 2019 - March 2020

Stage 2: Team Maturation, Deeper Substance Development

  • Changed emphasis from workstream to task-team centric
  • Matured concept model
  • Tooled process concept-based standards metadata to auto-create study artifacts

October 2019 - US Interchange

Stage 1: Project Evaluation – Next Six-month Plan

May 2019 - Oct 2019

Stage 1: Workstream Organization, Moving up the Learning Curve

  • Performed Workstream-centric Activities
  • Carried Out 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