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
<pending interchange recordings and presentations>
October 2020 - US Virtual Interchange
Stage 3: Project Evaluation
- Automation of ADaM & TFL Generation using CDISC 360 Enriched Standards
- Automation of SDTM Generation & Artifacts using CDISC 360 Enriched Standards
- Biomedical Concepts: What Did We Learn?
- PoC for Study Design and Configuration using CDISC 360 Concept-Based Standards
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
- Beyond Biomedical Concepts: How Study Management Concepts Fill the Gaps
- CDISC 360 Metadata-Driven Data Transformation Engine for Automation and Transparency
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
- 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
- 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.