118 lines
5.0 KiB
Markdown
118 lines
5.0 KiB
Markdown
# Clinical Measure Repository Quality Management System
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This repository contains template documents for implementing a Quality Management System (QMS) specifically designed for **Clinical Outcome Measures** and **Patient-Reported Outcomes (PRO)** repositories.
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## 📊 Designed For
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- Clinical Research Organizations managing outcome measures
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- Academic Medical Centers with measure development programs
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- Healthcare Quality Improvement departments
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- Psychometric Validation Teams
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- PRO/eCOA Implementation Teams
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- Clinical Trial Operations using validated measures
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- Registry Programs tracking clinical outcomes
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- Health Economics and Outcomes Research (HEOR) groups
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## Repository Structure
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```
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measure-repository/
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├── Policies/ # Quality policies for measure management
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├── SOPs/ # Standard Operating Procedures
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│ ├── Licensing/ # License agreements & copyright management
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│ ├── Validation/ # Psychometric validation procedures
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│ ├── Administration/ # Measure administration protocols
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│ ├── Translation/ # Translation & linguistic validation
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│ ├── Data-Management/ # Data collection, scoring, storage
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│ └── General/ # General quality operations
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├── Work Instructions/ # Detailed protocols and procedures
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├── Forms/ # Record forms and templates
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│ ├── License-Tracking/ # License agreements & renewals
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│ ├── Validation-Records/ # Validation study documentation
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│ ├── Training/ # Administrator training records
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│ └── Scoring/ # Scoring algorithms & interpretations
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└── Templates/ # Document templates
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```
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## Outcome Measure Types Covered
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- **PRO** - Patient-Reported Outcomes (e.g., SF-36, PROMIS, PHQ-9)
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- **ClinRO** - Clinician-Reported Outcomes (e.g., CGI-S, YBOCS)
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- **ObsRO** - Observer-Reported Outcomes (caregiver/proxy reports)
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- **PerfO** - Performance Outcomes (objective assessments, e.g., 6MWT, cognitive tests)
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## Document Numbering Convention
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- **POL-XXX**: Policies
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- **SOP-LIC-XXX**: Licensing SOPs
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- **SOP-VAL-XXX**: Validation SOPs
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- **SOP-ADM-XXX**: Administration SOPs
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- **SOP-TRN-XXX**: Translation SOPs
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- **SOP-DM-XXX**: Data Management SOPs
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- **SOP-GEN-XXX**: General SOPs
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- **WI-XXX**: Work Instructions / Protocols
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- **FRM-XXX**: Forms and Records
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- **LIC-XXX**: License Agreements/Tracking
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- **VAL-XXX**: Validation Reports
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- **SCR-XXX**: Scoring Algorithms
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## 🤖 AI-Powered Document Creation
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This template includes **AtomicAI** integration. Create an issue and mention `@atomicai` to:
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- Generate SOPs for measure licensing and copyright management
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- Create validation study protocols and documentation
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- Draft training materials for measure administrators
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- Develop scoring algorithms and interpretation guides
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- Create translation and linguistic validation procedures
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- Generate electronic vs paper administration protocols
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## Getting Started
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1. Create a new repository using this template
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2. Customize documents with your organization's information
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3. Add your validated measures to appropriate directories
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4. Create issues with `@atomicai` to generate new documents
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5. Review and approve AI-generated content via Pull Requests
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## Compliance & Best Practices
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These templates support compliance with:
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- **FDA PRO Guidance** (2009) - Patient-Reported Outcome Measures
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- **FDA BEST Framework** - Biomarkers, EndpointS, and other Tools
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- **ICH E9** - Statistical Principles for Clinical Trials
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- **ISPOR Guidelines** - Translation and Linguistic Validation
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- **COSMIN** - COnsensus-based Standards for the selection of health Measurement INstruments
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- **PROMIS** Standards - Patient-Reported Outcomes Measurement Information System
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- **21 CFR Part 11** - Electronic Records (for eCOA)
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- **HIPAA** - Health Information Privacy
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- **GDPR** - Data Protection (international studies)
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## Key Quality Considerations
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### Psychometric Properties
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- **Reliability**: Internal consistency, test-retest, inter-rater
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- **Validity**: Content, construct, criterion, known-groups
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- **Responsiveness**: Ability to detect meaningful change
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- **Interpretability**: Minimal clinically important difference (MCID), normative data
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### Licensing & Copyright
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- Track proprietary measure licenses and renewals
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- Maintain permissions for use, modification, and translation
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- Document copyright restrictions and attribution requirements
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- Manage royalty agreements for commercial use
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### Translation Management
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- Forward-backward translation methodology
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- Cultural adaptation and cognitive debriefing
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- Linguistic validation certificates
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- Version control for multi-language instruments
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### Administration Standards
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- Training and certification requirements for administrators
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- Paper vs electronic administration equivalence
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- Recall period and timing specifications
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- Instructions and response option standardization
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---
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*Powered by AtomicQMS - AI-Enhanced Clinical Measure Quality Management*
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