# 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] |