What’s in Your Kit?The Medical Translator’s Guide toNavigating Clinical Trials andInvestigational Documentation           ...
Webinar Quiz: Question 1What is the “gold standard” for collectingevidence about the performance of amedical device?    A....
Webinar Quiz: Question 2What is a “Notified Body” in Europeanmedical device regulation?    A. An entity of a national gove...
Webinar Quiz: Question 3Physicien (FR) means:    A.     Physical therapist    B.     Physician    C.     Physiologist    D...
Webinar Quiz: Question 4Which of these does not belong?    A.     Desinfectado (ES)    B.     Disinfected (EN)    C.     D...
Webinar Quiz: Question 5Documentation necessary to enroll a patientin a trial:    A.     Protocol    B.     Case report fo...
Webinar snapshot• To summarize the clinical trial pipeline• To address terminological challenges• To contextualize electro...
Clinical Trials: The BasicsWhat’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigat...
What is a clinical trial?• Biomedical or health-related research  studies that follow a pre-defined protocol• One of the f...
Types of clinical trials•   Treatment trials•   Prevention trials•   Diagnostic trials•   Screening trials•   Quality of l...
Clinical trial phases     What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigati...
Global: Not a should but a must• To strengthen intellectual property• To decrease time-to-market (millions in  potential r...
So many trials… so few patients    What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and In...
Poll 1: Foreign participation     What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Inv...
Poll 1: Foreign participationWhat percentage of subjects participating inclinical trials supporting marketingapplications ...
Growth in overseas trials• Over 40% of US-regulated trials are  conducted oversees• In the next two to three years, up to ...
Clinical trials around the world     What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and ...
International trials in the news     What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and ...
International standards• ICH Good Clinical Practice Guidelines    How trials should be conducted, roles and    responsibil...
Terminology ChallengesWhat’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational...
Medical usage and abusage• Default to literal/equivalence translations  may be inappropriate and/or deadly• Medical writin...
Poll 2: Localization     What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigatio...
Localization: Regulatory• Institutional Review Board (IRB) Group of scientists, doctors, clergy, and consumers at each par...
Regional divergences• Regional differences in the  regulatory/approval process• Locale-specific terminology• Variations in...
Observation: Canada tendsGeographic usage                                                                  to use the verb...
Terminology shifts• English has a relatively large vocabulary,  creating language shifts during translation       Source  ...
Faux amis – False friends• Cognates and faux amis can be deadly in  a clinical context        Source                  Faux...
Cases, Patients, Subjects, Controls• Patient  A person receiving medical care• Case  An instance of a disorder or disease•...
Efficacy vs. Effectiveness• Efficacy  Demonstrates a benefit under design or  research conditions (research setting)• Effe...
Prevalence vs. Incidence• Prevalence  Proportion of new events in a population or  group of patients• Incidence  The rate ...
Divergent medical terminology   Condition               Cause of                        English                           ...
Usage: For or against vaccines?Vaccin antigrippal, vaccin grippal, vaccin contre la grippe (FR)Vacuna antigripal, vacuna g...
Getting it Right: Term Mapping    What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Inv...
Remember:•   Know your limitations•   Expand your toolbox•   Different jobs require different approaches•   Don’t make ass...
Electronic Documentation        and TechnologyWhat’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Tr...
Wave of the future• It is only a matter of time before all source  data is captured in electronic format    Eliminates unn...
What is an eCRF?• A vehicle to assemble data from  electronic- and paper-based systems• Captures and organizes diverse dat...
Poll 3: eCRFs    What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Docu...
Poll 3: eCRFsTrue or False: eCRFs will replace ALLsource documentation (progress notes, labresults, X-rays, etc.)?        ...
Assembling data using an eCRF    What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Inve...
What does this mean fortranslators?• Translation and transfer of medical data to  a harmonized format• Translation of eCRF...
Translators and QA• Back-translation is an essential  benchmarking tool• Development of glossaries and controlled  input l...
Back-translation & in-countryreview• Informed consent forms, patient-reported  outcomes    Back-translation confirms that ...
Controlled language and CAT• Upstream internationalization and  localization of embedded systems• Mapping to classificatio...
A virtual collaborative environment• Translators link data managers and local  clinicians via central database regardless ...
Content repurposing• Translators adapt and repurpose content  (media syndication, Web publishing, etc.)• Trans-adaptation ...
A double-edged sword?• Accelerated timelines and more  commodity-driven process• TMs/glossaries are not “intelligent” tool...
ResourcesWhat’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
General Clinical Trial Resources•   EU Clinical Trials Register    Primary registry of WHO’s International Clinical Trials...
Clinical Trial Terminology•   Johns Hopkins Medicine IRB Guidelines    Glossaries, templates, and guidelines on the clinic...
Informed Consent•   Coded ICF Lexicon    Term or phrase with alternatives to medical terminology    www.calgb.org/Public/m...
Medical Terminology•   MediLexicon    Medical abbreviations and dictionary (English with some French, German,    and Spani...
Essential Print Resources•   Davis, Neil M. Medical Abbreviations: 15,000 Conveniences at the    Expense of Communications...
Tool Box For the Medical    Translator•   One of the most comprehensive lists of    resources for novice or experienced   ...
Questions?What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
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What's in your kit? The Medical Translator's Guide to Navigating Clinical Trials and Investigational Documentation

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Medical translators often focus on technical and scientific jargon when translating medical/instrumental reports, ICFs, regulatory correspondence, CRFs, or marketing and packaging materials. Navigating the lingo can be confusing, not to mention the added wrench of translation (comparison vs. comparator, effectiveness vs. efficacy, adverse events vs. adverse reactions). But looking beyond the task and understanding translation as part of the clinical trial process is crucial for translators working in this field.

This webinar will break down the technicalities and examine the clinical trial pipeline: the process, terminology, and documentation; the ethical, technical, and terminological challenges and choices faced by translators; electronic documentation and what technological developments mean for translators’ and country - and language-specific resources and glossaries.

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What's in your kit? The Medical Translator's Guide to Navigating Clinical Trials and Investigational Documentation

  1. 1. What’s in Your Kit?The Medical Translator’s Guide toNavigating Clinical Trials andInvestigational Documentation Erin M. Lyons
  2. 2. Webinar Quiz: Question 1What is the “gold standard” for collectingevidence about the performance of amedical 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. 3. Webinar Quiz: Question 2What is a “Notified Body” in Europeanmedical 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. 4. Webinar Quiz: Question 3Physicien (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. 5. Webinar Quiz: Question 4Which 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. 6. Webinar Quiz: Question 5Documentation necessary to enroll a patientin 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. 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. 8. Clinical Trials: The BasicsWhat’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
  9. 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. 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. 11. Clinical trial phases What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
  12. 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. 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. 14. Poll 1: Foreign participation What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
  15. 15. Poll 1: Foreign participationWhat percentage of subjects participating inclinical trials supporting marketingapplications for drugs were enrolled atforeign sites? 87% (foreign subjects in clinical trials on biologics) 21% 57%% 10%Source: “Challenges to FDAs 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. 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. 17. Clinical trials around the world What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
  18. 18. International trials in the news What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
  19. 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. 20. Terminology ChallengesWhat’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
  21. 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. 22. Poll 2: Localization What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
  23. 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. 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. 25. Observation: Canada tendsGeographic usage to use the verb recommander, which makes it impossible to use recommandations as the subject of the verb Term France Belgium Switzerland CanadaRecommandations 9 2Lignes directrices 1 2Guides 1 1Source: “Répertoire des lignes directrices de pratique médicale et tables rondesconsensus 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. 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. 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. 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. 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. 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. 31. Divergent medical terminology Condition Cause of English French conditionNatural sleep Sleep SommeilCondition in Hypnotism Hypnosis Hypnosewhich the (non-drug- Synonyms:patient related État hypnotiqueresponds to maneuvers) État hypnoïdesuggestion Narcoanalysis, Subnarcosis Subnarcose Narcosynthesis Synonyms: (Low doses of Hypnosis Narcose liminaire anesthesia) Hypnose* (not rec.)Artificial sleep, Drugs Narcosis NarcoseLoss of (somniferous Pharmacologicalconsciousness drugs, hypnosisfrom 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. 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. 33. Getting it Right: Term Mapping What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
  34. 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. 35. Electronic Documentation and TechnologyWhat’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
  36. 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. 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. 38. Poll 3: eCRFs What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
  39. 39. Poll 3: eCRFsTrue or False: eCRFs will replace ALLsource documentation (progress notes, labresults, X-rays, etc.)? True False What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
  40. 40. Assembling data using an eCRF What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
  41. 41. What does this mean fortranslators?• 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. 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. 43. Back-translation & in-countryreview• 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. 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. 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. 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. 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. 48. ResourcesWhat’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
  49. 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. 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. 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. 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. 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. 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. 55. Questions?What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation

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