Whether it is marketing a new medical device or putting a new drug on the market, the life sciences sector requires highly technical approaches when it comes to translating regulatory content for pharmaceutical, biotechnology, medical device, healthcare and clinical research companies.
For clinical research, patient-reported outcomes (PROs) play an integral role in whether a device or medication makes it to market. They provide valuable information that can impact the validity of a clinical trial. For this reason, PROs must undergo one of the most rigorous quality assurance processes called linguistic validation.
Katrina Honer, Senior Project Manager at Welocalize Life Sciences, shares why additional quality and accuracy assurances may be necessary for clinical research translation projects and how the process is conducted.
What It Is
Linguistic validation combines both translation and localization to investigate the reliability and validity of PROs measures. It is an extra step taken to ensure quality translations for highly sensitive, regulated documents and materials.
Why Linguistic Validation is Important
There are several instruments that can be used to obtain PROs and questionnaires are one of the most popular. Linguistic validation comes into play by ensuring what the translated questionnaire states in the target language accurately conveys the same meaning as the original source questionnaire. This involves a series of quality assurance checks to verify the translations are as linguistically and culturally accurate as possible. There are serious implications such as an entire trial being invalidated if proper data collection was not done due to ambiguous or incorrect translations.
Linguistic Validation encompasses several translation steps and either a Clinician Review, a Focus Group or both. All linguists involved are certified, native speakers of the target language being translated into and experts in the field of study. Here are the complete steps:
Step 1: Translatability Assessment
This is an optional service that Welocalize Life Sciences provides before translation begins. A linguist native of the target language being translated and an expert in the field of study analyzes the source questionnaire for clarity. Based on their findings, a discussion with the client is initiated to obtain suitable alternatives and options for ambiguous wording and phrases.
Step 2: Forward translation
Next, two independently working translators will translate the questionnaire into the target language producing two translated versions.
Step 3: Reconciliation
The two forward translations are then reviewed and reconciled by an independent editor and an additional proofreader into a single forward translation.
Step 4: Back translation
The reconciled translation is then back translated into the Original Source language by an independent editor and proofreader who did not work on the either the forward or reconciliation step.
Step 5: Equivalency stage
At this stage, the back translation is compared to the original Source questionnaire to ensure there are no discrepancies. The reconciliation team and the back-translation team will ensure to correct any mistranslations, omissions and additions that impact the originally intended meaning of the Source to produce the finalized version for linguistic validation.
Step 6: Linguistic Validation via Clinician’s Review or Cognitive Debriefing
At this stage, the finalized questionnaire will either undergo:
- Clinician review: Reviewed by an in-country clinician in the country intended for use. The clinician will summarize a report of proposed clarifications and/or clarifications for consideration.
- Cognitive debriefing via focus group: Questionnaire is tested on a small sample of individuals native in the target language and of various ages and education levels. A moderator (a linguist native in the target language) who conducts the focus group will document the participants’ responses and summarize a report of proposed clarifications and/or clarifications for consideration.
- Both a clinician review followed by cognitive debriefing.
Step 7: Final Translation Revision
The reconciliation translation team and back translation team will revise the translated questionnaire based on potential discrepancies identified in either the Clinician Review report or Focus Group report. These finalized versions are then used in the clinical trial.
When medical and clinical materials are translated, it is not just accuracy but also fluency of the overall content that matters. Welocalize Life Sciences’ translation, back translation and comparative review process ensures your investigator, regulatory and patient-facing documents are appropriate, accurate, consistent and compliant. Contact us for more information.