measure-repository/SOPs/Translation/SOP-TRN-001-Translation-Linguistic-Validation.md

# 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 |

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## 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

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## Revision History

| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |