Linguistic validation is the process of investigating the reliability, conceptual equivalence, and content validity of translations of patient-reported outcome (PRO) measures from clinical trials. Linguistic validation is the process through which the translated text, obtained through specific translation steps, is actively tested with patients in the target population and target language group through cognitive debriefing interviews.
At Transladiem, everything is done to ease the linguistic validation process and the localisation of instruments to offer a seamless experience to our stakeholders. Indeed, our Sales, Account Management and Production teams are proud to rely on industry experts, SMEs and a vast network of partners among the global medical workforce who are happy to accompany our clients through the whole process from the initial meetings, through the dual-forward translations, harmonisation, back-translation, reconciliation, cognitive debriefing and finalisation steps. We do follow scrupulously EMA and FDA requirements and always make sure to clarify key elements before proceeding (targeted audience, language specifics, testing support either paper or digital, etc).
Please see below a step-by-step guide to our linguistic validation process:
Initial meeting & brief
Upon receiving the source files from our client, we identify the content type and check that the files received are all editable and open properly. We also analyse them against our translation memories to see the final word count. It is important as well at this stage to gather all the elements about the respondents (age, gender, medical conditions, geographical areas) we need to source to test the PRO instruments. It is equally important to check whether the instruments will be provided as paper versions or digital versions as this can have an impact on how some queries are formulated and on how answers from the cognitive debriefing step will be collected. We will also need to get a clear understanding of the timeframe allocated to the project before the study submission to EC (Ethics Committees) and HA (Hospital Authority).
Quoting and Planning
At this stage we provide our client with a quotation in which we will itemise the services requested. All our quotations are free of charge. This is also the stage where we discuss the costs and timeline associated with the different project steps. Once we are all set and get the go-ahead, we can start the linguistic validation process.
File prep, Linguists & SMEs selection
While our team is organising the material received and making files localisation friendly, we are also lining up the correct resources for the project. We take great care in selecting the right linguists and SMEs for the specific areas covered by the instruments to be localised and linguistically validated. All our linguists and SMEs have areas of specialisation and native languages which need to match your project to be considered. It is our job to find the best suitable linguists and SMEs based on the specifics of the project.
Dual-forward translation & Verification
The files to be localised have been prepped for translation in a previous step and are now sent to the relevant linguists that will work on the project. Our linguistic validation process requires to execute two translations in parallel on the same source documents, in order to obtain two set of translations from two different linguists. The translations received are then QA’ed by our project team through our internal verification step.
Our project team then compares the two translations obtained with the SMEs, native speakers of the target languages, in order to flag any major discrepancies between the two translations obtained, as this could potentially reveal a translation issue that needs to be investigated and addressed. Based on the two translations, our team and the SME manage to agree on a unique final version for the translation that combine the best options from both translations we had received.
The project team then organises the back translation of the harmonised copy back into the source language.
Our project team then compares the original source document with the back-translated document with the SMEs, native speakers of the target language, in order to flag any major discrepancies between the two copies, as this could potentially reveal a translation issue that needs to be investigated and addressed. Based on the two copies at hand, our team and the SME manage to pinpoint if there is any area in the back translated document that would stray away from the original meaning present in the source document. If this is the case, our team, the SME and the linguists involved will rework these points so to refine the phrasing and wording to always better the outcome and remove any potential ambiguity.
Revision, also called proofreading, & Validation
The SME compares the source text against the reconciled target text to make sure the translation is accurate and true to the source text. The proofread translation is then QA’ed by our project manager team through our internal validation step.
The cognitive debriefing step is where we line up patients or respondents with medical staff in the target countries to produce a comprehensive report on how the translations have been perceived. This testing session must be performed in accordance with the client requirements. The instrument will be linguistically tested by the required number of respondents for each target language and all findings are clearly documented in a report.
Finalisation, Formatting and Delivery
Our project team and the project SME of each target language will analyse the report and check the outcome detailed in the reports. The reactions, questions and answers of the respondents to the queries are documented and will be used to fine-tune the translations further to ensure that the localised instrument will deliver exactly the intended results and fully serve the purpose of the study. Once the final amendments are made or final sign-off is given, your dedicated account manager will deliver the final localised instruments to you via the delivery method agreed upon (email, FTP, secured link) and expect feedback. Our team will also deliver the project certificate and the statements of truth signed by all resources used throughout the project.