This document discusses resources for medical translators working with clinical trial documentation. It begins with an overview of clinical trials, their phases and global nature. It then addresses terminology challenges, including differences between languages and regions. The document reviews how electronic case report forms and technology impact translation work. It concludes by recommending general and terminology-focused clinical trial resources for translators.

1. What’s in Your Kit?
The Medical Translator’s Guide to
Navigating Clinical Trials and
Investigational Documentation
Erin M. Lyons

2. Webinar Quiz: Question 1
What is the “gold standard” for collecting
evidence about the performance of a
medical device?
A. Case series
B. Randomized controlled trial
C. Observational study
D. Integrative study
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

3. Webinar Quiz: Question 2
What is a “Notified Body” in European
medical device regulation?
A. An entity of a national government in the EU
entitled to grant approval
B. A private organization accredited by the
government entitled to grant approval
C. The manufacturer labeling the product with the
CE marking
D. A subcommittee of the Directorates-General of
Health and Consumers
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

4. Webinar Quiz: Question 3
Physicien (FR) means:
A. Physical therapist
B. Physician
C. Physiologist
D. Physicist
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

5. Webinar Quiz: Question 4
Which of these does not belong?
A. Desinfectado (ES)
B. Disinfected (EN)
C. Désinfecté (FR)
D. Desinfektiert (DE)
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

6. Webinar Quiz: Question 5
Documentation necessary to enroll a patient
in a trial:
A. Protocol
B. Case report form
C. Informed consent form
D. Investigator’s brochure
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

7. Webinar snapshot
• To summarize the clinical trial pipeline
• To address terminological challenges
• To contextualize electronic documentation
and technological developments
for translators
• To identify dedicated linguistic resources
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

8. Clinical Trials: The Basics
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

9. What is a clinical trial?
• Biomedical or health-related research
studies that follow a pre-defined protocol
• One of the final stages in the long process
of drug research and discovery
• Required for marketing authorization
from regulatory authorities
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

10. Types of clinical trials
• Treatment trials
• Prevention trials
• Diagnostic trials
• Screening trials
• Quality of life/Supportive care trials
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

11. Clinical trial phases
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

12. Global: Not a should but a must
• To strengthen intellectual property
• To decrease time-to-market (millions in
potential revenue)
• To capitalize on seasonal reversal in
Southern Hemisphere (allergies, flu, etc.)
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

13. So many trials… so few patients
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

14. Poll 1: Foreign participation
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

15. Poll 1: Foreign participation
What percentage of subjects participating in
clinical trials supporting marketing
applications for drugs were enrolled at
foreign sites?
87% (foreign subjects in clinical trials on biologics)
21%
57%%
10%
Source: “Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trials,”
Dept. of Health and Human Services Office of Inspector General, June 2010.
http://oig.hhs.gov/oei/reports/oei-01-08-00510.pdf
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

16. Growth in overseas trials
• Over 40% of US-regulated trials are
conducted oversees
• In the next two to three years, up to 65%
of FDA-regulated trials will be
conducted abroad
• “Pharmerging” markets: Brazil, China,
Russia, India
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

17. Clinical trials around the world
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

18. International trials in the news
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

19. International standards
• ICH Good Clinical Practice Guidelines
How trials should be conducted, roles and
responsibilities of sponsors, investigators, and
monitors Available in multiple
languages (including
• Declaration of Helsinki glossaries)
Ethical principles on human experimentation;
cornerstone document for human research ethics
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

20. Terminology Challenges
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

21. Medical usage and abusage
• Default to literal/equivalence translations
may be inappropriate and/or deadly
• Medical writing uses a specific style and
jargon that can be foreign to linguists
• Interlinguistic shifts in terminology
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

22. Poll 2: Localization
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

23. Localization: Regulatory
• Institutional Review Board (IRB)
Group of scientists, doctors, clergy, and
consumers at each participating health facility
who evaluate and approve the trial design
and protocol.
Ethics Committee (EC)
Comité de protection de personnes (CPP)
Research Ethics Board (REB)
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

24. Regional divergences
• Regional differences in the
regulatory/approval process
• Locale-specific terminology
• Variations in healthcare systems
• Readability index for target population
(consent forms, patient information, etc.)
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

25. Observation: Canada tends
Geographic usage to use the verb
recommander, which makes
it impossible to use
recommandations as the
subject of the verb
Term France Belgium Switzerland Canada
Recommandations 9 2
Lignes directrices 1 2
Guides 1 1
Source: “Répertoire des lignes directrices de pratique médicale et tables rondes
consensus francophones, ” http://www.chu-rouen.fr/ssf/recomfr.html, p. 1-6.
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

26. Terminology shifts
• English has a relatively large vocabulary,
creating language shifts during translation
Source Translation Comment
Aches and pains Rigidez (ES) 2 words do not exist in
Spanish for “aches”
and “pains”
Cytomegalovirus No abbreviation available in
(CMV) (--) (EL) Greek, use full term
Magnetic Resonance Segulómun (MRI) Interchangeable use of full
Imaging (MRI) (IS) Icelandic term and borrowed
EN term
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

27. Faux amis – False friends
• Cognates and faux amis can be deadly in
a clinical context
Source Faux amis translation Correct translation
(RU) Angina (EN) Tonsillitis
Auricle (FR) Auricle (EN) Atrium
After (DE) After (EN) Anus
Carbunco (ES) Carbuncle (EN) Anthrax
Aspirazione (IT) Aspiration (EN) Suction
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

28. Cases, Patients, Subjects, Controls
• Patient
A person receiving medical care
• Case
An instance of a disorder or disease
• Subject
A human/animal with a particular characteristic
• Control (subject)
A human/animal that does not have that
particular characteristic
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

29. Efficacy vs. Effectiveness
• Efficacy
Demonstrates a benefit under design or
research conditions (research setting)
• Effectiveness
Demonstrates a benefit under conditions of
actual use (day-to-day clinical practice)
Example: Pulse oximeters have demonstrated
their efficacy, but clinical studies are being
performed to demonstrate their effectiveness
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

30. Prevalence vs. Incidence
• Prevalence
Proportion of new events in a population or
group of patients
• Incidence
The rate of development of new events in a
population or group of patients per unit of time
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

31. Divergent medical terminology
Condition Cause of English French
condition
Natural sleep Sleep Sommeil
Condition in Hypnotism Hypnosis Hypnose
which the (non-drug- Synonyms:
patient related État hypnotique
responds to maneuvers) État hypnoïde
suggestion Narcoanalysis, Subnarcosis Subnarcose
Narcosynthesis Synonyms:
(Low doses of Hypnosis Narcose liminaire
anesthesia) Hypnose* (not rec.)
Artificial sleep, Drugs Narcosis Narcose
Loss of (somniferous Pharmacological
consciousness drugs, hypnosis
from anesthesia anesthesia) Sleep* (not rec.)
(deep sleep) Hypnosis* (not Hypnose* (not rec.)
rec.)
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

32. Usage: For or against vaccines?
Vaccin antigrippal, vaccin grippal, vaccin contre la grippe (FR)
Vacuna antigripal, vacuna gripal, vacuna contra la gripe (ES)
Flu vaccine (EN)
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

33. Getting it Right: Term Mapping
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

34. Remember:
• Know your limitations
• Expand your toolbox
• Different jobs require different approaches
• Don’t make assumptions: check and
double check
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

35. Electronic Documentation
and Technology
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

36. Wave of the future
• It is only a matter of time before all source
data is captured in electronic format
Eliminates unnecessary duplication of data
Reduces the opportunity for transcription errors
Promotes real-time entry of source data during visits
Ensures the accuracy and completeness of data
• Until then… we have the eCRF!
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

37. What is an eCRF?
• A vehicle to assemble data from
electronic- and paper-based systems
• Captures and organizes diverse data to
satisfy the study protocol
• Enables the data to be systematically
reviewed and analyzed by investigators
and other authorized parties
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

38. Poll 3: eCRFs
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

39. Poll 3: eCRFs
True or False: eCRFs will replace ALL
source documentation (progress notes, lab
results, X-rays, etc.)?
True
False
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

40. Assembling data using an eCRF
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

41. What does this mean for
translators?
• Translation and transfer of medical data to
a harmonized format
• Translation of eCRF and QA prompts
• Translation of site-specific reporting forms
for automated import into eCRF
• Translation of local proprietary input
systems (not global-ready)
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

42. Translators and QA
• Back-translation is an essential
benchmarking tool
• Development of glossaries and controlled
input language for languages/locales
• Stakeholder in regulatory review/audits
• “Clean” data review
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

43. Back-translation & in-country
review
• Informed consent forms, patient-reported
outcomes
Back-translation confirms that content and readability
are unaffected
• Marketing materials and labeling
In-country review guarantees appropriateness for
specific markets
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

44. Controlled language and CAT
• Upstream internationalization and
localization of embedded systems
• Mapping to classifications and standard
glossaries (Systematized Nomenclature of
Medicine – Clinical Terms, SNOMED CT)
• Downstream translation and retooling for
specific markets
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

45. A virtual collaborative environment
• Translators link data managers and local
clinicians via central database regardless
of language or location
• Multilingual IVRS integration
• Real-time roll-out of protocol changes
• Translators on call for out-of-box
adverse events
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

46. Content repurposing
• Translators adapt and repurpose content
(media syndication, Web publishing, etc.)
• Trans-adaptation and push-button
publishing
• Consolidation and review in
regulated fields
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

47. A double-edged sword?
• Accelerated timelines and more
commodity-driven process
• TMs/glossaries are not “intelligent” tools
• Technological learning curve
for translators
• Costly add-on tools?
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

48. Resources
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

49. General Clinical Trial Resources
• EU Clinical Trials Register
Primary registry of WHO’s International Clinical Trials Registry Platform
www.clinicaltrialsregister.eu
• European Union Drug Regulating Authorities Pharmacovigilance
(EudraVigilance)
EMA scientific guidelines
www.Eudravigilance.emea.europe.eu
• US Clinical Trials Database
US registry of clinical trials in a harmonized format
www.clinicaltrials.gov
• WHO International Clinical Trials Registry Platform (ICTRP)
Online, multilingual international clinical trials registry
www.who.it/ictrp/en
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

50. Clinical Trial Terminology
• Johns Hopkins Medicine IRB Guidelines
Glossaries, templates, and guidelines on the clinical trial process
www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/gu
idelines/
• The Medical Dictionary for Regulatory Activities (MedDRA)
Reference for describing adverse events
www.meddramsso.com
• Stanford Clinical Trials Dictionary
Glossary of terms specific to clinical research
humansubjects.stanford.edu/new/docs/glossary_definitions/definitions.pdf
• Stanford Lay Language Dictionary
Glossary of medical terms and corresponding lay terms and definitions
humansubjects.stanford.edu/new/docs/glossary_definitions/lay_language.p
df
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

51. Informed Consent
• Coded ICF Lexicon
Term or phrase with alternatives to medical terminology
www.calgb.org/Public/meetings/presentations/2009/summer_group/cra_con
t_ed/04c_lexicon_062009.pdf
• Stanford ICF templates and subject bill of rights
With templates in English, Chinese, Farsi, Japanese, Korean, Russian,
Spanish, and Vietnamese
humansubjects.stanford.edu/new/resources/consent/short_form_consent_pr
ocess.html
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

52. Medical Terminology
• MediLexicon
Medical abbreviations and dictionary (English with some French, German,
and Spanish translations)
www.medilexicon.com
• Medline Plus Dictionary
National Library of Medicine Dictionary
www.nlm.nih.gov/medlineplus/mplusdictionary.html
• RxList
Online drug index, including side effects, interactions, etc.
www.rxlist.com
• EMA
Frequently used non-standard abbreviations
http://www.emea.europa.eu/htms/human/qrd/docs/listnonstandard.pdf
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

53. Essential Print Resources
• Davis, Neil M. Medical Abbreviations: 15,000 Conveniences at the
Expense of Communications and Safety, 10th ed. Huntington Valley, PA:
Davis Associates, 2001.
• Donaldson, Ross. Tarascon Medical Translation Pocketbook, 1 Mul. ed.
Boston: Jones and Bartlett: 2009.
• Maxwell, Robert. Maxwell Quick Medical Reference, 5th ed. Maxwell Pub.
Co., 2006.
• Sabatine, Marc S. Pocket Medicine: The Massachusetts General Hospital
Handbook of Internal Medicine , 3rd ed. Philadelphia: Wolters Kluwer, 2008.
• Stanaszek, Mary J. The Inverted Medical Dictionary. Lancaster, PA:
Technomic, 1991.
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

54. Tool Box For the Medical
Translator
• One of the most comprehensive lists of
resources for novice or experienced
medical translators
http://www.groupetraduction.ca/documents/ToolBox.pdf
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

55. Questions?
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation