GLOBAL WORKFORCE: Translation Best Practices
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GLOBAL WORKFORCE:
Translation Best Practices
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Scale management is a complex endeavor for all of those involved. In addition to acquiring English
language versions of scales, acquiring its foreign language counterpart can be a complicated project,
especially given varying copyright holder requirements. Often, a translated version of a scale does not
exist. If commercially available translations do not exist, it will be necessary to translate scales into the
required language following the International Society for Pharmacoeconomics and Outcomes Research
(ISPOR) Principles of Good Practice for Translation and Cultural Adaption Process for Patient-Reported
Outcomes, as well as forward and backward corroboration by an experienced network of native speaking
clinicians. Furthermore, comprehensive translation services may include psychometric and cultural
validation.
If acquiring commercially-available scale translations, it is recommended to obtain the English source file
from which the translation was created and comparing to the English source file used in the clinical trial. It
is also recommended that your vendor should obtain the certificate of translation and verify that the
translation methodology matches current standards used for translation.
The importance of accurate scale translation must not be denied as its implications are profound. Without
accurate scale translations, clinical trial outcomes can potentially have a significant variance and
ultimately result in additional costs or setbacks for Sponsors.
As a standard, best practices for linguist selection include individuals with the following credentials:
Linguist’s Required Credential & Translation Technology
Required Credentials
• Must be native speakers of the target language
• Fluent in English
• Must maintain in-country residency within the target country within the last 5 years for up to three
months (residency months may be nonconsecutive)
• At least 5 yrs of medical translation experience
This ensures that the translator is well versed in the language and can fluidly create translations that are
accurate for the modern context in which they are translating.
Translation Technology
Bracket translators utilize technology (translation memory and translation management systems) to
ensure consistency and accuracy and to reduce timelines without compromising quality. Translation
memory tools are NOT machine translation. The Bracket translation memory system stores previously-
existing translation units and attributes for use in new translation projects.
The translation memory can populate the target document with sentences that appear in the database.
The linguist then reviews all match categories prior to accepting the translation for use in the existing
project, and modifies as necessary to ensure that the translation matches the English source text and is
appropriate in context. Translation memory files are built continuously as the translator works through a
document, so that the translator can leverage a translation that was used at the beginning of the
document for consistency.Linguistic Validation (LV) with Cognitive Debriefing
Cognitive debriefing (also known as cognitive interviewing) allows for the assessment patient
interpretation by selecting a sample of patients to interview. This is an important step in understanding
patients’ mindset and understanding of questionnaires.
Cognitive debriefing is recommended for patient-reported outcome measures when these PRO measures
are used as primary or secondary endpoints, at minimum, because of the greater risk of patient
misunderstanding which could occur. If the Sponsor requests elimination of the native clinician review
and/or the cognitive debriefing step due to timelines and/or cost, the quality of the translation work
completed cannot be guaranteed, as a crucial check has been omitted.
Translation Steps
• Preflight (or concept elaboration)
• Translation manager conducts initial review of the source text (to identify the intended
meaning and flag any items that may not be culturally relevant in the target countries)
• Bracket clinicians add clinical comments/clarification as needed
• Dual forward translation
• Two native-speaking linguists separately complete independent forward translations
• Reconciliation
• A third independent, native-speaking linguist reconciles the two forward translations
• Discrepancies, linguistic limitations, and cultural differences are noted, researched, and
resolved to produce a single reconciled translation
• Back translation
• A native-speaking linguist translates the reconciled document back into the source
language
• The back translator is provided with only the reconciled forward translation as source
material – he/she has no knowledge of the original source text or the concept definitions
from the initial preflight step
• Back translation review and reconciliation
• A clinician and/or translation manager compares each English back translation to the
English source in order to affirm the conceptual integrity of the scale in its translation.
• The linguistic team reviews the clinician’s comments and implements changes as needed
• International harmonization (skip this step if only one language is being validated)
• Translation project manager identifies conceptually similar or problematic items that have
occurred across all languages, and addresses issues and solutions with linguistic teams
in order to achieve cross-cultural equivalence
• Native-speaker medical review
• A physician who both works in the specific therapeutic area for the study and is a native-
speaker of the target language reviews and addresses specific items of interest for
accuracy of medical language in relation to the disease state
• Cognitive debriefing (also sometimes referred to as pilot testing, which typically involves a larger
group of patients)
• Translation company conducts face-to-face qualitative interviews with 5-10 patients in the
study’s target population (who have no prior knowledge of the questionnaire)
• During the cognitive debriefing process, the patients are asked to provide feedback such
as:
1. How they understand each item
Page 2 of 52. What it means to them in their own words
3. Recommendations for improving the wording
4. Whether the response options are appropriate
Warning! Possible risks involved with foregoing the cognitive debriefing process may
include:
Translation may include terminology not commonly understood by the patient population,
resulting in potential lack of understanding or incorrect interpretation by the patient, who
may have a different education level than the linguists and clinicians who have previously
reviewed the translations
Potential culturally irrelevant examples could be used, resulting in confusion for the
patient
• Final proofreading and delivery
• Text is formatted and then proofread in its final format by a senior native-speaking linguist
• Certificate of translation is provided upon delivery of the final translation
Linguistic Validation (LV) without cognitive debriefing
This process is recommended for clinician-rated scales and for Patient Reported Outcomes (PROs) that
are NOT used as primary or secondary endpoints. If the Sponsor requests elimination of the native
clinician review step due to timelines and/or cost, Bracket cannot guarantee the quality of the translation
work completed for this project.
Steps Involved
1. Preflight (or concept elaboration)
• Translation manager conducts initial review of the source text (to identify the intended
meaning and flag any items that may not be culturally relevant in the target countries)
• Bracket clinicians add clinical comments/clarification as needed
2. Dual forward translation
• Two native-speaking linguists separately complete independent forward translations
3. Reconciliation
• A third independent, native-speaking linguist reconciles the two forward translations
• Discrepancies, linguistic limitations, and cultural differences are noted, researched, and
resolved to produce a single reconciled translation
4. Back translation
• A native-speaking linguist translates the reconciled document back into the source
language
• The back translator is provided with only the reconciled forward translation as source
material – he/she has no knowledge of the original source text or the concept definitions
from the initial preflight step
5. Back translation review and reconciliation
• A clinician and/or translation manager compares each English back translation to the
English source in order to affirm the conceptual integrity of the scale in its translation
• The linguistic team reviews the clinician’s comments and implements changes as needed
Page 3 of 56. International harmonization (skip this step if only one language is being validated)
• Translation project manager identifies conceptually similar or problematic items that have
occurred across all languages, and addresses issues and solutions with linguistic teams
in order to achieve cross-cultural equivalence
7. Native-speaker medical review
• A physician who both works in the specific therapeutic area for the study and is a native-
speaker of the target language reviews and addresses specific items of interest for
accuracy of medical language in relation to the disease state
8. Final proofreading and delivery
• Text is formatted and then proofread in its final format by a senior native-speaking linguist
• Certificate of translation is provided upon delivery of the final translation
Translation/Editing/Proofreading (TEP) + back translation (BT)
Bracket recommends translation, editing, and proofreading with back translation for site-facing web
interface text, especially when using computerized cognitive assessments.
Steps Involved
1. Three separate native-speaking linguists perform the translation, editing, and proofreading
2. A native-speaking linguist (who does not have access to the original source text or any reference
documents) translates the target text back into the source language
3. Any discrepancies between the source text and the back translation text are researched and
resolved
4. Text is formatted and then proofread in its final format
5. Certificate of translation can be provided upon request
Translation/Editing/Proofreading (TEP)
Also sometimes referred to as “forward translation,” Bracket recommends this process for clinician-facing
general text translations such as user manuals, PowerPoint presentations, narratives, subtitles, and
transcripts.
Steps Involved
1. Two separate native-speaking linguists perform the translation and editing
2. Text is formatted and then proofread in its final format by a third native-speaking linguist
3. For voiceover projects, recordings are provided by a native-speaking professional voice talent for
each target language
4. Certificate of translation can be provided upon request
In summary, it is extremely important to work with an experienced, internationally-focused, culturally
aware vendor when outsourcing scale management during a clinical trial. As noted previously, clinical trial
outcomes can potentially have a significant variance without accurate scale translations, which risks
additional costs and can contribute to the overall success or failure of a trial – something on which most
Sponsors do not want to take a chance.
Page 4 of 5Authors
Christina Hughes, BS, MBA
Christina Hughes is a Senior Director, Client Services with Bracket. Christina manages project teams in
the execution of Bracket’s Scientific Services global investigator training, scale management, endpoint
reliability, and cognition services. Specifically, Christina also serves as the Product Business Owner for
the Translations service offering and as such, manages the Translations department within Bracket.
Previously, Christina worked for Cap Gemini Ernst & Young and Deloitte Consulting in their health care
divisions. Christina has a degree in Biology from Yale University and an MBA from the University of
Pennsylvania.
Keli Platco, BA
Keli is an Associate Director with Bracket, providing training, education and consulting services to the
pharmaceutical industry. Keli has over 11 years of Clinical Research experience. Prior to Bracket, Keli
held various Clinical Research positions ranging from the university level at the University of
Pennsylvania to working for a large pharmaceutical company. Keli has a degree in Psychology with a
concentration in Neuroscience from Temple University.
Rachel Cornelius, BA
Rachel is a Manager for Bracket Translation Services, managing translations for psychometric scales
(patient-reported outcomes as well as clinician-rated scales), subtitling and voiceover for videos, training
presentations, and more. Prior to Bracket, Rachel held positions in Project Management within the
publishing and computer software industries. Rachel has four years experience within the clinical
research field and ten years experience within the translation field. Rachel has a degree in German and
Russian language studies, with a minor in International Studies, from Millersville University of
Pennsylvania, and has also studied French, Latin, and Romanian.
Bracket is a specialty services provider dedicated to helping pharmaceutical sponsors and contract
research organizations achieve greater certainty and accurate outcomes in their clinical trials by
seamlessly leveraging science, technology and operational excellence.
For more information, contact Bracket at +1 610 225-5900 or by email at info@bracketglobal.com
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