CDISC 360

CDISC 360 is an ambitious new project geared toward innovating clinical data standards to ensure they remain valuable and relevant into the future. CDISC 360 aims to support standards-based, metadata-driven automation across the end-to-end clinical research data lifecycle and represents a significant next step toward realizing an increased return on investment in standards implementation that our stakeholders expect – substantially improved efficiency, consistency, and re-usability.

We are inviting your organization to join us in this important project by getting involved. CDISC values the input and collaboration of our members; we want to ensure your needs and expectations are taken into account so that the project achieves results that are supported and endorsed by our community.

Project Description

The Opportunity

The CDISC foundational standards define research data and metadata structures, but writing these standards as documents has yielded more text than metadata. Gaps in standards metadata limit automation opportunities. The inherent flexibility provided by the standards supports a broad range of implementations, but that flexibility also allows for inconsistencies that make scaling automation difficult. The lack of a conceptual foundation for the standards further contributes to these inconsistencies. The relationships that would be expressed by these concepts remain largely implicit in the current versions of the standards.

CDISC 360 seeks to implement 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 consume this new metadata to ease standards implementations while increasing data processing efficiencies.

CDISC 360 will demonstrate the feasibility of standards-based metadata-driven automation as a start towards 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.

Objectives

CDISC 360 will develop proof-of-concept enhancements to the CDISC standards metadata as well as related proof-of-concept software to confirm that the enhanced standards can be used to automate preparation of study specification metadata and end-to-end study data processing.

The focal point of this project is concept-based modeling. CDISC will not deliver software to industry as an outcome of CDISC 360. However, during the project, an enhanced set of API prototypes will be developed to demonstrate that the concept-based metadata can be accessed in order to implement metadata-driven automation.

Scope

CDISC 360 will implement end-to-end standards-based metadata-driven automated processing by conducting three use cases, demonstrated by implementing portions of the CDISC Type 1 Diabetes TAUG.

Metadata / Data Processing Use Cases

  • Use Case 1: Create end-to-start specification – Demonstrate the ability to produce a standards-based, machine-readable specification for the data and analysis artifacts to be created in the study.
  • Use Case 2: Generate start-to-end metadata - Demonstrate the ability to generate study-specific artifacts given the standards specification from Use Case 1.
  • Use Case 3: Transform data start-to-end - Demonstrate the ability to process data and execute data transformations given the study specification from Use Case 2.

Demonstration using Selected Artifacts from the CDISC Type 1 Diabetes TAUG

The test study used in CDISC 360 to demonstrate use of the concept-based standards will be composed of the following selected artifacts from the CDISC Type 1 Diabetes TAUG. If the participant response is large enough, we may extend the scope to include a suite of safety concepts.

  • 1 or 2 statistical end points
    • Analysis of Glycated Hemoglobin
    • Summary of Hypoglycemic episodes
  • ~3-4 ADaM datasets
  • ~7-8 SDTM datasets
    • DM (Demographics, so support standard variables in ADSL)
    • VS (Vital Signs, for height and weight in ADSL)
    • CM (Concomitant Medications, to support stratification by background treatment, and for treatments of hypoglycemic events)
    • LB (for Hemoglobin A1C data)
    • CE and FACE (for data on hypoglycemic events)
    • EX, ML (for data about meals and study treatments relative to hypoglycemic events)
    • Trial Design datasets (for arms, visit schedule, definition of hypoglycemic events as disease milestones)
  • ~15 CDASH CRFs
    • CDASH CRFs needed to support SDTM datasets above. One CRF will support collection of data about hypoglycemic events that will be mapped to multiple SDTM domains.
Project Methodology

The project will be conducted using an agile methodology. All project workstreams will potentially be active during each sprint.

Project Workstreams

Following is our best initial understanding of the project workstreams, subject to change as the project’s agile sprints unfold.

  • Workstream 1 – Analysis concept development – human-consumable
  • Workstream 2 – Analysis concept development – machine-consumable
  • Workstream 3 – Extended standard dataset definitions to include transformations
  • Workstream 4 – End-to-start standards-based specification development (Use Case 1)
  • Workstream 5 – Start-to-end study-specific metadata development (Use Case 2)
  • Workstream 6 – Transform data start-to-end (Use Case 3)
Project Duration

Project duration is estimated to be 18 months.

Expected Outcomes
  • Demonstrate standards metadata-driven automation
  • Model and document the prototype new standards metadata developed for CDISC 360
  • Standards gap analysis
  • Technology gap analysis
  • Assess the feasibility of producing a solution that scales
  • Future standards development roadmap
Critical Success Factors
  • Prove the feasibility of standards-based end-to-end automation
  • Document the new standards metadata required to support end-to-end automation
Alignment with Other Strategic Initiatives

CDISC 360 aligns with other strategic initiatives and commitments:

Additional Description of the CDISC 360 Project

Additional description of the CDISC 360 project is available by downloading the accompanying slide deck.

Questions can be sent to info@cdisc.org.

Project workstream activities began the week of 8 April 2019.