A comprehensive platform for creating, managing, and standardizing analysis metadata for clinical trials according to the CDISC Analysis Results Standard (ARS).

• Standards Compliant: Built on CDISC Analysis Results Standard (ARS)
• User-Friendly: Intuitive wizards and visual designers
• Collaborative: Real-time collaboration with version control
• Extensible: API-first architecture with comprehensive integrations
• Scalable: From single-user to enterprise deployments

Get up and running in minutes:

# Clone the repository
git clone https://github.com/cdisc-org/analysis-results-standard.git
cd analysis-results-standard

# Quick setup
./setup-infrastructure.sh all

# Start the application
./deploy.sh dev start

Access the application at http://localhost:3000

New to the system? Check out our Quick Start Guide for a 15-minute tutorial.

📖 View All Documentation

The system consists of:

• Frontend: React/TypeScript application
• Backend: FastAPI with Python
• Database: PostgreSQL for data persistence
• Cache: Redis for performance
• Deployment: Docker and Kubernetes ready

• Create standardized analysis specifications
• Generate programming code templates
• Validate analysis compliance
• Export to SAS/R/Python formats

• Design analysis plans visually
• Collaborate on statistical methods
• Review and approve specifications
• Ensure regulatory compliance

• Standardize analysis metadata
• Manage template libraries
• Track analysis lineage
• Export for submissions

• ✅ Phase 1: Foundation (Complete)
• ✅ Phase 2: Core Features (Complete)
• ✅ Phase 3: Advanced Features (Complete)
• ✅ Phase 4: Polish & Deploy (Complete)

Current version: v1.0 - Production Ready

Backend:

• Python 3.11+
• FastAPI
• PostgreSQL
• Redis
• Docker

Frontend:

• React 18+
• TypeScript
• Ant Design
• Vite

Infrastructure:

• Docker Compose
• Kubernetes
• GitHub Actions
• Monitoring & Logging

Minimum:

• 4 GB RAM
• 20 GB storage
• Modern web browser

Recommended:

• 8+ GB RAM
• 100+ GB SSD
• High-speed internet

./deploy.sh dev start

kubectl apply -f k8s/

Supports AWS, Azure, GCP with managed services.

See Installation Guide for detailed instructions.

We welcome contributions! See our Contributing Guide for details.

1. Fork the repository
2. Create a feature branch
3. Make your changes
4. Run tests
5. Submit a pull request

• Industry-standard encryption
• Role-based access control
• Audit logging
• GDPR/HIPAA compliance ready
• Regular security updates

• Documentation: docs/
• Issues: GitHub Issues
• Discussions: GitHub Discussions
• Community: CDISC Community

This project is licensed under the MIT License - see the LICENSE file for details.

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

• 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

• 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

• 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

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

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

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.

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

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

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.