Description

The goals of CDISC Analysis Results Standards team is to develop:

• Analysis Results Metadata Technical Specification (ARM-TS), to support automation, traceability, and creation of data displays
• Define an Analysis Results Data (ARD) structure, to support reuse and reproducibility of results data
• Illustrate and exercise ARD and ARM-TS with a set of machine-readable common safety displays
• Develop a logical analysis results metamodel to support ARM and ARD
  • Including model definition
  • User Guide
  • API development
  • Conformance rules
  • Terminology

Background

• Unnecessary variation in analysis results reporting
• Limited CDISC standards to support analysis results and associated metadata
• CDISC has been working towards creating standards to support, consistency, traceability, and reuse of results data
• We anticipate that the CDISC work will support sponsor submissions of analysis results in a standard format that aligns with the FDA effort

Analysis Results Current State

• Static results created for Clinical Study Report
• May be hundred of tables in PDF format, often difficult to navigate
• Variability between sponsors
• Expensive to generate and only used once, no or limited reusability
• ARM v1.0 describes metadata about analysis displays and results (at a high level), no formal analysis and results model or results data
• Lack of features to drive automation
• Limited regulatory use cases
• Limited traceability

Analysis Results Future State

• Formal model for describing analyses and results as data
• Facilitate automated generation of results
• From static to machine readable results
• Improved navigation and reusability of analyses and results
• Support storage, access, processing and reproducibility of results
• Traceability to Protocol/SAP and to input ADaM data
• Open-source tools to design, specify, build and generate analysis results

Documentation

The documentation of the model is made available at: https://cdisc-org.github.io/analysis-results-standard/

Reference CDISC Pilot Study Material

The study documents and datasets referenced/utilized by the ARS development team is available at: https://github.com/cdisc-org/sdtm-adam-pilot-project

Contribution

Project Contact:

• Bhavin Busa (https://github.com/bhavinbusa): Product Owner and Co-lead
• Bess LeRoy (https://github.com/bessleroy): Co-lead
• Richard Marshall (https://github.com/ASL-rmarshall): ARS model developer
• Drew Mills (https://github.com/drewcdisc): Scrum Master

Contribution is very welcome. When you contribute to this repository you are doing so under the below licenses. Please checkout Contribution for additional information. All contributions must adhere to the following Code of Conduct.

License

Code & Scripts

This project is using the MIT license (see LICENSE) for code and scripts.

Content

The content files like documentation and minutes are released under CC-BY-4.0. This does not include trademark permissions.

Re-use

When you re-use the source, keep or copy the license information also in the source code files. When you re-use the source in proprietary software or distribute binaries (derived or underived), copy additionally the license text to a third-party-licenses file or similar.

When you want to re-use and refer to the content, please do so like the following:

Content based on Project CDISC Analysis Results Standards (GitHub) used under the CC-BY-4.0 license.