Presentation working on clinical trials
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Working on Clinical Trials
• Introduction to clinical trials (what are they; how do they work; who is implied)
• Types of documents used in clinical trials (medical [specialist facing/ patient facing]; legal; marketing, etc.)
• Types of audiences (doctors/investigators/healthcare providers; patients/ other laymen such as healthy subjects/ partners/ legal representatives/ parents, etc.; ECs; CROs…)
• What skills do linguists need to work in this field?• How to acquire that knowledge?
- Where to find glossaries/ templates/ further information- MOOCs to take to get you started- Books and articles you should have read- Other handy resources
Introduction to Clinical Trials
http://web.chem.ucla.edu/~harding/IGOC/C/clinical_trial.html
Legal Basics:
• clinical trials have to comply with strict regulations• Declaration of Helsinki• International Conference on Harmonization of Technical Requirements for the
Registration of Pharmaceuticals for Human Use (ICH) > Good Clinical Practice (GCP)
• national/ EU guidelines (AMG, EU Clinical Trials Directive)• national/ EU regulatory authorities (BfArM, PEI, EMA)
Introduction to Clinical Trials
http://web.chem.ucla.edu/~harding/IGOC/C/clinical_trial.html
Important for linguists:
• different conditions and medical specializations• different types of documentation• many texts have to be handed in for approval > have to adapt to
certain specifications
Introduction to Clinical Trials
• Prospective biomedical or behavioral research study of human subjects
• Designed to answer specific questions about biomedical or behavioral interventions e.g.:
• vaccines, • drugs, • treatments, • devices, • new ways of using known drugs, treatments, or devices
• Used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective
• Include behavioral human subjects research involving an intervention to modify behavior
• increasing the use of an intervention• willingness to pay for an intervention, etc.
Clinical trials of experimental drug, treatment, device or behavioral intervention may proceed through four phases
Phase IFirst stage testing a new intervention in humans
10 - 30 people
identify tolerable dose
information on drug metabolism, excretion, toxicity
not necessarily controlled
Phase II30 - 100 people
preliminary information on efficacy, additional information on safety and side effects
Phase III100 + people
efficacy and safety
controlled and normally randomized
Phase IV conducted after the intervention has been marketed
monitor effectiveness of the approved intervention in the general population
collect information about any adverse effects
http://web.chem.ucla.edu/~harding/IGOC/C/clinical_trial.html
Types of documents used in Clinical Trials
According to Good Clinical Practice (GCP), all information and processes of clinical trials must be recorded and stored so that they can be correctly reported, interpreted and authenticated. Many different types of documents are created, processed and filed in the process of clinical studies.As per ICH GCP E6 Section 8, essential documents are those which:
(…) individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.
Other important uses and objectives of essential documents are:• correct management of the trial in question by investigators, sponsors and monitors;• audits;• inspections by regulatory authorities.
There are mainly three stages in which essential documents are generated and handled, namely:
1 Before the start of the clinical phase of the trial2 During the clinical phase of the trial3 After the clinical phase of the trial
All documentation needs to be described and it must be defined whether they are stored in the files of either the study site (investigator or institution), the sponsor, or both. See the European Commission’s Detailed Guidance on the Content of a Trial Master File and Archiving for more information on Trial Master Files. In some cases, documents may be combined if all essential parts are still clear and can be easily identified.
Very few clinical trials are conducted only in one country; many are available in a variety of different sites in different places, so the translation and linguistic adaptation for different target cultures and languages becomes more important. However, requirements as to which types of documents need to be translated differ from country to country. Whereas in some states all documents need to be available in the local language, others assume that specialist-facing text will be understood in English, and only texts that are not directly addressing the study staff involved in the trial need to be translated, such as:
• Packaging and labeling• Patient diaries• Patient information sheets• Informed consent forms• Patient questionnaires• Patient-reported outcomes
Types of documents used in Clinical Trials
Before the start of the clinical phase of the trial
Authorization/approval/notifications by regulatory authorities (if applicable)Certificate of Analysis of Investigational Products shippedComposition of Institutional Review Board (IRB) and Independent Ethics Committee (IEC)Curriculum Vitae and other relevant information/documents regarding the qualification of the investigators involved in the trialDecoding procedures for blinded trialsDocumentation from IRB (only applicable in the US) and/or IEC providing approval/favorable opinion on:
• Protocol and its amendments (if applicable)• Case Report Form (CRF) (if applicable)• ICF(s)• Other written information for subjects• Advertisement for subject recruitment (if applicable)• Subject compensation (if applicable)• Any other documents that require approval/a favorable opinion
Financial aspects of the trialInformation given to trial subjects, such as:
• Informed Consent Form (ICF). All applicable translations also have to be filed• Other written information• Marketing material for subject recruitment (if applicable)
Insurance statement
Instructions for handling of investigational product and trial-related materials
Investigator’s brochureMaster randomization listMedical/laboratory/technical procedures and/or tests:
• Certification, or• Accreditation, or• Established quality control and/or external quality assessment, or• Other validation (if applicable)
Normal values for medical/laboratory/technical procedures and/or tests included in the protocol
Pre-trial monitoring reportSample of labels for investigational product containersShipping records for investigational products and trial-
related materialsSigned agreement between involved parties, such as:
• Investigator/institution and sponsor• Investigator/institution and Contract Research Organization (CRO)• Sponsor and CRO• Investigator/institution and authorities.
Signed protocol and amendments (if applicable); sample CRF
Trial initiation monitoring report
Types of documents used in Clinical Trials
During the clinical phase of the trial
Any revisions to:• Protocol/amendments and CRF• Informed consent form• Other written information provided to subjects• Advertisement for subject recruitment
Certificate of analysis for new batches of investigational productsCurriculum Vitae for new investigatorsDated and documented approval/favorable opinion of IRB/IEC of
the following:• Protocol amendments• Revisions of:• Informed consent form• Other written information to be provided to the subject• Advertisement for subject recruitment• Any other documents given approval/favorable opinion• Continuing review of trial (if applicable)
Documentation of CRF correctionsDocumentation of investigational products and trial-related
materials shipmentInterim or annual reports to IRB/IEC and authority or authoritiesInvestigational products accountability at the siteInvestigator’s brochure updatesMonitoring visit reportsNotification by originating investigator to sponsor of serious
adverse events and related reports
Notification by sponsor and/or investigator (where applicable) to the regulatory authority or authorities and IRB/IEC of unexpected serious adverse drug reactions as well as other safety information
Notification by sponsor to investigators of safety informationRecord of retained body fluids/tissue samples (if applicable)Regulatory authorities authorizations/approvals/notifications where
required for protocol amendments and other documentsRelevant communications other than site visits
• Letters• Meeting notes• Notes of telephone calls
Signature sheetSigned informed consent formsSigned, dated and completed CRFsSource documentsSubject enrollment logSubject identification code listSubject screening logUpdates regarding medical/laboratory/technical procedures/tests
in the protocolUpdates of medical/laboratory/technical procedures/tests:
• Certification, or• Accreditation, or• Established quality control and/or external quality assessment, or• Other validation (where required)
Types of documents used in Clinical Trials
After the clinical phase of the trial
Audit certificate (if applicable)Clinical study reportCompleted subject identification code listDocumentation of investigational product destructionFinal report by investigator to IRB/IEC where required, and to the regulatory authority or authorities (if applicable)Final trial close-out monitoring reportInvestigational product accountability at siteTreatment allocation and decoding documentationTypes of audiences (doctors/investigators/healthcare providers; patients/ other laymen such as healthy subjects/ partners/ legal representatives/ parents, etc.; ECs; CROs…)
Types of audiences• Doctors/ investigators/
healthcare providers • Patients• Other laymen such as
healthy subjects/ partners/ legal representatives/ parents, etc.
• ECs; CROs
What skills do linguists need to work in this field?•Basic knowledge about the functioning of clinical trials
•Specific terminology•Adapt texts for different audiences
What skills do linguists need to work in this field?Laymen texts:
• patients or voluntary participants
• family/spouse/guardian
• avoid anglicisms/ latinisms if they are not widely understood
• style and expression should be easy to understand
• no long and complicated syntax
Influenza > Flu
Placebo > Placebo
Screening > Voruntersuchung
depends on language (Romance languages + English > layman term often = Latin term; other Germanic languages normally don’t use the Latin term in every day language)
Example solutions:
• omit specialist term
The patient has a fever.
• give explanation + specialist term in brackets
The patient has a fever (pyrexia).
• give specialist term and explain in brackets
The patient has pyrexia (fever).
What skills do linguists need to work in this field?
> Double check with client/ style guides that may have been provided as this might depend on ECs/ Regulatory Authorities (local entities) > might even be handled differently for different languages in the same study.
> You can also check instructions directly on the websites of the Ethics Committee in question
How to acquire that knowledge?
• Where to find glossaries/ templates/ further information
• MOOCs to take to get you started• Books and articles you should have read• Other handy resources
Where to find glossaries/ templates/ further
information
https://clinicaltrials.gov/ct2/info/glossary
Where to find glossaries/ templates/ further
information
https://medlineplus.gov/mplusdictionary.html
Where to find glossaries/ templates/ further
information
https://prsinfo.clinicaltrials.gov/definitions.html
Where to find glossaries/ templates/ further
informationNCI Drug Dictionary
https://www.cancer.gov/publications/dictionaries/cancer-drug/
Thieme
https://www.thieme.de/viamedici/klinik-infos-zur-klinik-1516/a/abkuerzungen-3968.htm
Beckers Abkürzungslexikonhttp://www.medizinische-abkuerzungen.de/
Univadis
https://www.univadis.com/references
Dornblüth Klinisches Lexikon
http://www.textlog.de/9609.html
DocCheck Flexikon
http://translate.google.de/translate?js=n&prev=_t&hl=de&ie=UTF-8&layout=2&eotf=1&sl=de&tl=en&u=http://flexikon.doccheck.com&act=url
MediLexicon
http://www.medilexicon.com/
Medizin Lexikon
http://www.gesundheit.de/lexika/medizin-lexikon
Dorlands
https://www.dorlands.com/wsearch.jsp
Cosnautas
http://www.cosnautas.com/catalogo
Tremédica
http://www.tremedica.org/panacea/IndiceGeneral/n44_tradyterm-EVazquezDelArbol.pdf
Lista de Glosarios en español
http://pablomuguerza.com/minicoleccion-de-glosarios-y-buscadores-de-acronimos-y-siglas/
Where to find glossaries/ templates/ further
information
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000134.jsp&mid=WC0b01ac0580022c59
Where to find glossaries/ templates/ further
information
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000134.jsp&mid=WC0b01ac0580022c59
Where to find glossaries/ templates/ further
information
https://www.ecpdwebinars.co.uk/downloads/ema-templates-and-eu-terminology-for-medical-translators-the-basics-2/
Where to find glossaries/ templates/ further
informationEthic Committees
http://www.swissethics.ch/templates.html
http://ethikkommission.blaek.de/studien/amg-studien
http://ethikkommission.meduniwien.ac.at/service/patienteninformation/
http://www.medunigraz.at/ethikkommission/Graz/Richtl/frame.htm
https://www.medunigraz.at/ethikkommission/Forum/Download/piev.htm
https://ethikkommission.charite.de/antraege/
http://www.ak-med-ethik-komm.de/index.php?lang=de
http://www.uni-regensburg.de/medizin/ethikkommission/weitere-informationen/patienteninformation/index.html
MOOCs to take to get you started
Johns Hopkins University:
▪ Design and Interpretation of Clinical Trials
https://www.coursera.org/learn/clinical-trials
▪ Introduction to Systematic Review and Meta-Analysis
https://www.coursera.org/learn/systematic-review
National Drug Abuse Treatment Clinical Trials Network:
Good Clinical Practice
https://gcp.nihtraining.com/
National Institutes of Health:
Clinical Research Training
https://crt.nihtraining.com/
University of California, San Diego:
• Drug Discovery
https://www.coursera.org/learn/drug-discovery
• Drug Development
https://www.coursera.org/learn/drug-development
• Drug Commercialization
https://www.coursera.org/learn/drug-commercialization
University of Cape Town:
Understanding Clinical Research: Behind the Statistics https://www.coursera.org/learn/clinical-research
University of Minnesota:
Healthcare Marketplace
https://www.coursera.org/learn/healthcare-marketplace
University of Pennsylvania:
Vital Signs: Understanding What the Body Is Telling Us
https://www.coursera.org/learn/vital-signs
University of Pittsburgh:
Clinical Terminology for International and U.S. Students
https://www.coursera.org/learn/clinical-terminology
Vanderbilt University:
Data Management for Clinical Research
https://www.coursera.org/learn/clinical-data-management
Books and articles• Daniela Penn: Ein Überblick über klinische Studien und das Übersetzen von Studiendokumenten
• http://www.bdue-fachverlag.de/fachverlag/detail_book/110
• Shayne Cox Gad: Clinical Trials handbookhttps://books.google.es/books?id=d8GxG0d9rpgC&pg=PA118&redir_esc=y#v=onepage&q&f=false
•
• S. D. MathiasS. K. FiferD. L. Patrick:Rapid translation of quality of life measures for international clinical trials: avoiding errors in the minimalist approach
• http://link.springer.com/article/10.1007/BF00435392
• Dictionaries for your language combination
Other handy resources
NIH Toolkit for Clinical Researchers• https://www.nidcr.nih.gov/research/toolkit/#start
up2
UBC Webinars• http://www.ubc.com/library/archived-webinars
USC Information about Clinical Trials• https://research.usc.edu/clinical-trials-at-usc/
NCI's Clinical Trials Programs and Initiatives• https://www.cancer.gov/research/areas/clinical-t
rials
My blog• http://www.henter.co/documents-used-in-clinical
-trials/• http://www.henter.co/specialization-courses-for-
medical-translators-and-interpreters/