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

Create a new repository using this template
Customize documents with your organization's information
Add your validated measures to appropriate directories
Create issues with @atomicai to generate new documents
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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