measure-repository/README.md

Clinical Measure Repository Quality Management System

This repository contains template documents for implementing a Quality Management System (QMS) specifically designed for Clinical Outcome Measures and Patient-Reported Outcomes (PRO) repositories.

📊 Designed For

• Clinical Research Organizations managing outcome measures
• Academic Medical Centers with measure development programs
• Healthcare Quality Improvement departments
• Psychometric Validation Teams
• PRO/eCOA Implementation Teams
• Clinical Trial Operations using validated measures
• Registry Programs tracking clinical outcomes
• Health Economics and Outcomes Research (HEOR) groups

Repository Structure

measure-repository/
├── Policies/                  # Quality policies for measure management
├── SOPs/                      # Standard Operating Procedures
│   ├── Licensing/             # License agreements & copyright management
│   ├── Validation/            # Psychometric validation procedures
│   ├── Administration/        # Measure administration protocols
│   ├── Translation/           # Translation & linguistic validation
│   ├── Data-Management/       # Data collection, scoring, storage
│   └── General/               # General quality operations
├── Work Instructions/         # Detailed protocols and procedures
├── Forms/                     # Record forms and templates
│   ├── License-Tracking/      # License agreements & renewals
│   ├── Validation-Records/    # Validation study documentation
│   ├── Training/              # Administrator training records
│   └── Scoring/               # Scoring algorithms & interpretations
└── Templates/                 # Document templates

Outcome Measure Types Covered

• PRO - Patient-Reported Outcomes (e.g., SF-36, PROMIS, PHQ-9)
• ClinRO - Clinician-Reported Outcomes (e.g., CGI-S, YBOCS)
• ObsRO - Observer-Reported Outcomes (caregiver/proxy reports)
• PerfO - Performance Outcomes (objective assessments, e.g., 6MWT, cognitive tests)

Document Numbering Convention

• POL-XXX: Policies
• SOP-LIC-XXX: Licensing SOPs
• SOP-VAL-XXX: Validation SOPs
• SOP-ADM-XXX: Administration SOPs
• SOP-TRN-XXX: Translation SOPs
• SOP-DM-XXX: Data Management SOPs
• SOP-GEN-XXX: General SOPs
• WI-XXX: Work Instructions / Protocols
• FRM-XXX: Forms and Records
• LIC-XXX: License Agreements/Tracking
• VAL-XXX: Validation Reports
• SCR-XXX: Scoring Algorithms

🤖 AI-Powered Document Creation

This template includes AtomicAI integration. Create an issue and mention @atomicai to:

• Generate SOPs for measure licensing and copyright management
• Create validation study protocols and documentation
• Draft training materials for measure administrators
• Develop scoring algorithms and interpretation guides
• Create translation and linguistic validation procedures
• Generate electronic vs paper administration protocols

Getting Started

1. Create a new repository using this template
2. Customize documents with your organization's information
3. Add your validated measures to appropriate directories
4. Create issues with @atomicai to generate new documents
5. Review and approve AI-generated content via Pull Requests

Compliance & Best Practices

These templates support compliance with:

• FDA PRO Guidance (2009) - Patient-Reported Outcome Measures
• FDA BEST Framework - Biomarkers, EndpointS, and other Tools
• ICH E9 - Statistical Principles for Clinical Trials
• ISPOR Guidelines - Translation and Linguistic Validation
• COSMIN - COnsensus-based Standards for the selection of health Measurement INstruments
• PROMIS Standards - Patient-Reported Outcomes Measurement Information System
• 21 CFR Part 11 - Electronic Records (for eCOA)
• HIPAA - Health Information Privacy
• GDPR - Data Protection (international studies)

Key Quality Considerations

Psychometric Properties

• Reliability: Internal consistency, test-retest, inter-rater
• Validity: Content, construct, criterion, known-groups
• Responsiveness: Ability to detect meaningful change
• Interpretability: Minimal clinically important difference (MCID), normative data

Licensing & Copyright

• Track proprietary measure licenses and renewals
• Maintain permissions for use, modification, and translation
• Document copyright restrictions and attribution requirements
• Manage royalty agreements for commercial use

Translation Management

• Forward-backward translation methodology
• Cultural adaptation and cognitive debriefing
• Linguistic validation certificates
• Version control for multi-language instruments

Administration Standards

• Training and certification requirements for administrators
• Paper vs electronic administration equivalence
• Recall period and timing specifications
• Instructions and response option standardization

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