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# Standard Operating Procedure: Translation and Linguistic Validation of Clinical Outcome Measures
| Document ID | SOP-TRN-001 |
|-------------|---------|
| Title | Translation and Linguistic Validation of Clinical Outcome Measures |
| Revision | 1.0 |
| Effective Date | [DATE] |
| Author | [AUTHOR] |
| Approved By | [APPROVER] |
| Department | Outcomes Research |
---
## 1. Purpose
This procedure establishes requirements for translating and linguistically validating clinical outcome measures to ensure conceptual equivalence across languages and cultures while maintaining psychometric properties.
## 2. Scope
This procedure applies to:
- Translation of validated outcome measures into new languages
- Linguistic validation of existing translations
- Cultural adaptation for different regions
- All measure types (PRO, ClinRO, ObsRO, PerfO)
## 3. Responsibilities
### 3.1 Translation Project Manager
- Oversee translation process
- Select and manage translation vendors
- Coordinate with copyright holders
- Ensure adherence to ISPOR guidelines
- Maintain translation documentation
### 3.2 In-Country Coordinator
- Recruit local translators and reviewers
- Arrange cognitive debriefing sessions
- Provide cultural context and guidance
- Review translations for local appropriateness
### 3.3 Quality Manager
- Review translation methodology
- Ensure documentation completeness
- Verify copyright permissions
- Approve final translated versions
## 4. Definitions
| Term | Definition |
|------|------------|
| Source Language | The original language of the measure (typically English) |
| Target Language | The language into which the measure is being translated |
| Forward Translation | Translation from source to target language |
| Backward Translation | Translation from target language back to source language |
| Reconciliation | Process of resolving discrepancies between translations |
| Cognitive Debriefing | Qualitative interviews with target population to assess comprehension |
| Linguistic Validation | Process of ensuring translation maintains conceptual equivalence |
| Conceptual Equivalence | Same meaning and relevance across languages and cultures |
## 5. Procedure
### 5.1 Pre-Translation Activities
5.1.1. Verify translation rights:
- Check license agreement for translation permissions
- Contact copyright holder for authorization
- Determine if official translations already exist
- Document translation approval in FRM-TRN-001
5.1.2. Assess target country/region:
- Identify target language and dialect
- Consider cultural differences affecting concepts
- Determine literacy level of target population
- Identify any regional variations needed
5.1.3. Obtain source materials:
- Current version of source measure
- Administration instructions
- Conceptual framework and item intent
- Previous translation memory if available
- Validation data for reference
5.1.4. Select translation methodology:
- Standard ISPOR methodology (most common)
- Copyright holder's proprietary process if required
- Other recognized methods (e.g., EORTC, WHO)
5.1.5. Assemble translation team:
- Forward translators (2 required)
- Backward translator (1 required)
- In-country reviewer
- Native speakers of both languages
- Healthcare/clinical expertise preferred
### 5.2 Forward Translation
5.2.1. Conduct independent forward translations:
- Two translators work independently
- Native speakers of target language
- Fluent in source language
- One "informed" (aware of measure purpose)
- One "uninformed" (naive to measure concepts)
5.2.2. Forward translation guidelines:
- Aim for conceptual rather than literal translation
- Maintain level of language (lay vs technical)
- Preserve recall period and response options
- Note any translation challenges or ambiguities
- Document rationale for translation choices
5.2.3. Document forward translations in FRM-TRN-002:
- Original item
- Translator 1 version
- Translator 2 version
- Translator notes and rationale
### 5.3 Reconciliation of Forward Translations
5.3.1. Convene reconciliation meeting:
- Both forward translators
- In-country reviewer
- Project manager (may be remote)
5.3.2. Review each item systematically:
- Compare translation versions
- Discuss differences and rationale
- Consider cultural appropriateness
- Select preferred translation or create synthesis
- Reach consensus on single forward translation
5.3.3. Document reconciliation:
- Final reconciled translation
- Rationale for choices made
- Unresolved issues for further review
- Record in FRM-TRN-002
### 5.4 Backward Translation
5.4.1. Conduct independent backward translation:
- Translator different from forward translators
- Native speaker of source language
- Fluent in target language
- "Uninformed" - not previously exposed to measure
5.4.2. Translate reconciled version back to source language:
- Translate without seeing original source version
- Note any items difficult to translate back
- Provide literal translation
- Document in FRM-TRN-003
5.4.3. Compare backward translation to original:
- Identify discrepancies
- Assess whether differences indicate translation problems
- Consider whether adjustments needed
- Minor wording differences acceptable if concept maintained
### 5.5 Harmonization Review
5.5.1. Conduct harmonization meeting:
- Translation team
- Project manager
- Clinical/outcomes expert
- Copyright holder representative if required
5.5.2. Review backward translation comparison:
- Identify items with poor backward translation
- Discuss whether forward translation needs revision
- Consider alternative translations
- Update forward translation as needed
5.5.3. Review across measure:
- Ensure consistent terminology throughout
- Check consistency of instructions and response options
- Verify formatting and layout match original
- Finalize translated version
5.5.4. Document harmonization decisions in FRM-TRN-004
### 5.6 Cognitive Debriefing
5.6.1. Prepare cognitive debriefing protocol:
- Semi-structured interview guide
- Probes for comprehension and interpretation
- Questions about acceptability and relevance
- Typically 5-8 participants from target population
5.6.2. Recruit appropriate participants:
- Representative of intended respondent population
- Native speakers of target language
- Range of ages, education levels, disease severity
- Geographic diversity if regional dialects exist
5.6.3. Conduct cognitive debriefing interviews:
- Participant completes measure
- Interview about specific items:
* "What does this question mean to you?"
* "How did you decide on your answer?"
* "Is anything confusing or difficult to understand?"
* "Are any words or phrases unclear?"
- Probe problematic items in depth
- Document participant feedback
5.6.4. Analyze cognitive debriefing results:
- Identify items with comprehension problems
- Determine whether issues are widespread or isolated
- Assess whether revisions needed
- Document in FRM-TRN-005
### 5.7 Translation Revision (if needed)
5.7.1. If cognitive debriefing identifies problems:
- Convene translation team
- Develop alternative translations for problematic items
- Consider cultural adaptation if needed
- Document rationale for revisions
5.7.2. Conduct additional cognitive debriefing:
- Test revised items with new participants
- Continue until no significant issues identified
- Typically 5 participants per iteration sufficient
### 5.8 Proofreading and Finalization
5.8.1. Independent proofreading:
- Native speaker not involved in translation
- Check spelling, grammar, punctuation
- Verify consistency throughout
- Compare to source for formatting
5.8.2. Format final translation:
- Match layout of original measure
- Ensure readability (font size, spacing)
- Include all instructions and response options
- Add translation identification (language, version, date)
5.8.3. Create final translation package:
- Translated measure
- Administration instructions (translated)
- Scoring instructions (if publicly available)
- Translation certificate
- Linguistic validation report
### 5.9 Copyright Holder Review (if required)
5.9.1. Submit translation for approval:
- Final translated measure
- Translation methodology documentation
- Linguistic validation report summary
- Cognitive debriefing results
5.9.2. Address any copyright holder feedback:
- Make required revisions
- Document changes and rationale
- Obtain final approval
5.9.3. File approval in license documentation
### 5.10 Translation Documentation
5.10.1. Compile linguistic validation report:
- Translation methodology used
- Team qualifications
- Forward and backward translation results
- Cognitive debriefing findings
- Revisions made and rationale
- Conclusions regarding conceptual equivalence
5.10.2. Create translation certificate including:
- Source and target languages
- Measure name and version
- Translation completion date
- Certification that ISPOR guidelines followed
- Signatures of translation team lead and project manager
5.10.3. Archive all translation documentation:
- All translation versions
- Meeting notes and reconciliation records
- Cognitive debriefing transcripts and summaries
- Linguistic validation report
- Copyright holder correspondence
- File in Translation Database (FRM-TRN-006)
### 5.11 Cultural Adaptation
5.11.1. When cultural adaptation needed beyond translation:
- Identify culture-specific concepts requiring adaptation
- Consult with local clinical and cultural experts
- Modify items while maintaining conceptual equivalence
- Consider alternative examples or phrases
- Document all adaptations and justification
5.11.2. For substantial cultural adaptations:
- Consider conducting psychometric validation
- May require copyright holder approval
- May result in "culturally adapted version" designation
### 5.12 Electronic Format Considerations
5.12.1. For eCOA implementations:
- Verify text fits within screen space
- Check for right-to-left language considerations
- Test all navigation and response capture
- Ensure proper character encoding
- Validate against paper version
5.12.2. Document any format adaptations required
## 6. Related Documents
- FRM-TRN-001: Translation Authorization Form
- FRM-TRN-002: Forward Translation Documentation
- FRM-TRN-003: Backward Translation Documentation
- FRM-TRN-004: Harmonization Meeting Notes
- FRM-TRN-005: Cognitive Debriefing Summary
- FRM-TRN-006: Translation Database
- FRM-TRN-007: Translation Certificate Template
- SOP-LIC-001: License Management
- SOP-VAL-002: Cross-Cultural Validation
## 7. References
- Wild D, et al. (2005). Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation. Value in Health, 8(2), 94-104
- Wild D, et al. (2009). Multinational trials - recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: The ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force Report
- FDA (2009). Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
- Acquadro C, et al. (2008). Literature Review of Methods to Translate Health-Related Quality of Life Questionnaires for Use in Multinational Clinical Trials. Value in Health, 11(3), 509-521
---
## Revision History
| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |