Sync template from atomicqms-style deployment

README.md

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-# measure-repository
+# 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.
+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
+
+---
+*Powered by AtomicQMS - AI-Enhanced Clinical Measure Quality Management*