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
- ADSL(Subject-Level Analysis Data (ADSL))
- Hemoglobin A1C Analysis Dataset (HbA1c Analysis Dataset)
- Hypoglycemic Episodes Analysis Dataset (Hypoglycemic Episodes Analysis Dataset)
- Hypoglycemic Episodes Summary Dataset (Hypoglycemic Episodes Summary Dataset)
- ~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)
Please see the CDISC 360 Project Workstreams and Participation spreadsheet for further description of each workstream.
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:
- Helmsley Transformational Grant
- Blue Ribbon Commission
- TransCelerate Digital Data Flow
- CDISC Data Exchange Standards
Additional Description of the CDISC 360 Project
Additional description of the CDISC 360 project is available by downloading the accompanying slide deck.
Participation Details
Participation Roles and Effort
The project will break new ground and the work will be challenging. To meet this challenge and to maximize success, we seek a focused and active project team that will work in and across the project workstreams. See the CDISC 360 Project Workstreams and Participation spreadsheet for a description of the roles, responsibilities, skill sets, and backgrounds sought per workstream. This is our initial understanding of the project as we organize; as with any agile development, the exact set of project workstreams/activities is subject to change as the sprints unfold.
This is not an opportunity for casual team members who want to take on an observer role to keep informed of project progress. We will regularly communicate project progress with the CDISC community for those members simply interested in the overall project activities and progress.
We seek individuals who can serve in the following capacities:
- Workstream Leader – 50% FTE minimally and optimally 75% FTE or more of active leadership for at least a six-month period.
- Workstream Member – 25% FTE minimally and optimally 50% FTE or more of active participation for at least a six-month period.
These %FTE numbers are guidelines, not strict requirements. We seek these amounts due to the challenging nature of this project, but we want to understand from you what amount of time you are able to provide.
How to Participate
The project began 8 April 2019; project duration is estimated to be 18 months.
We continue to welcome active participants to contribute talent. Click the button below and complete the requested information.
CDISC held a webinar 19 February 2019 to present the 360 project description and answer questions. We invite those considering in contributing talent to the project to listen to the webinar archive.
We have also made available the transcript of the questions and answers from the webinar.
Questions during the response period can be sent to info@cdisc.org.