105 lines
5.1 KiB
Markdown
105 lines
5.1 KiB
Markdown
# Quality Policy - Clinical Outcome Measures Management
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| Document ID | POL-001 |
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| Title | Quality Policy - Clinical Outcome Measures Management |
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| Revision | 1.0 |
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| Effective Date | [DATE] |
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| Author | [AUTHOR] |
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| Approved By | [APPROVER] |
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---
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## 1. Policy Statement
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[ORGANIZATION NAME] is committed to maintaining the highest standards in clinical outcome measure development, validation, implementation, and data management. We ensure that all patient-reported outcomes (PROs), clinician-reported outcomes (ClinROs), observer-reported outcomes (ObsROs), and performance outcomes (PerfOs) used in our research and clinical programs meet rigorous psychometric standards and regulatory requirements.
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## 2. Quality Objectives
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Our organization commits to:
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1. **Scientific Rigor**: Ensuring all outcome measures demonstrate appropriate reliability, validity, responsiveness, and interpretability
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2. **Regulatory Compliance**: Maintaining compliance with FDA PRO Guidance, ICH guidelines, and other applicable regulations
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3. **Intellectual Property Protection**: Respecting copyright, licensing requirements, and intellectual property rights for all proprietary measures
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4. **Cultural Sensitivity**: Ensuring proper translation and linguistic validation for international use
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5. **Data Integrity**: Maintaining accurate scoring, data collection, and outcome assessment procedures
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6. **Training Excellence**: Ensuring all personnel are appropriately trained and certified in measure administration
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7. **Continuous Improvement**: Regularly reviewing and updating measure selection, validation, and implementation procedures
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## 3. Management Commitment
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Top management demonstrates commitment to clinical outcome measure quality by:
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- Ensuring adequate resources for psychometric validation studies
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- Supporting proper licensing and intellectual property management
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- Promoting evidence-based measure selection aligned with study objectives
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- Ensuring translation and linguistic validation follow ISPOR guidelines
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- Maintaining separation between clinical care and research assessments where appropriate
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- Supporting training and certification programs for measure administrators
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- Ensuring electronic clinical outcome assessment (eCOA) systems meet 21 CFR Part 11 requirements
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- Engaging with measure developers, copyright holders, and licensing organizations appropriately
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- Reviewing measure performance data and validation evidence regularly
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## 4. Scope
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This policy applies to:
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- All clinical outcome measures used in research studies
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- Patient-reported, clinician-reported, observer-reported, and performance outcomes
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- Psychometric validation activities
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- Measure licensing and copyright management
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- Translation and linguistic validation projects
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- Training and certification of measure administrators
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- Electronic and paper-based outcome assessment systems
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- Scoring algorithms and data interpretation procedures
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## 5. Key Principles
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### 5.1 Measure Selection
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- Select measures with demonstrated psychometric properties appropriate to the study population and objectives
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- Consider respondent burden, literacy requirements, and cultural appropriateness
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- Document rationale for measure selection with reference to published validation evidence
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- Obtain necessary licenses and permissions before use
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### 5.2 Psychometric Validation
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- Conduct validation studies following established methodologies (COSMIN, FDA PRO Guidance)
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- Document reliability (internal consistency, test-retest, inter-rater)
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- Establish validity (content, construct, criterion)
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- Assess responsiveness and minimal clinically important difference (MCID)
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- Generate normative data or reference values when appropriate
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### 5.3 Licensing & Copyright
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- Identify and track all proprietary measures requiring licenses
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- Maintain current license agreements and ensure compliance with terms
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- Track license renewal dates and usage restrictions
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- Document copyright attributions and obtain permissions for modifications
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- Manage royalty payments for commercial use
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### 5.4 Translation & Linguistic Validation
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- Follow ISPOR principles of good practice for translation and linguistic validation
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- Use forward-backward translation methodology
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- Conduct cognitive debriefing with target population
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- Obtain linguistic validation certificates
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- Maintain version control for all language versions
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### 5.5 Training & Certification
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- Ensure administrators are trained in measure-specific procedures
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- Document training completion and certification status
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- Maintain competency through periodic refresher training
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- Follow measure developer requirements for administrator qualifications
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## 6. Communication
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This policy shall be:
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- Communicated to all personnel involved in outcome measure activities
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- Available to study sponsors, regulatory authorities, and other stakeholders as appropriate
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- Reviewed annually for continuing suitability
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- Updated to reflect changes in regulatory requirements and scientific best practices
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---
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## Revision History
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| Rev | Date | Description | Author |
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|-----|------|-------------|--------|
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| 1.0 | [DATE] | Initial release | [AUTHOR] |
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