Certified Medical Translations
Translation of Informed Consent Forms
For medical research institutions / clinical trial professionals / regulatory compliance coordinators who need the translation of an Informed Consent Form into the language of a research participant.
We have experienced medical translators in many language pairs with a proven track record. Most of our translators are certified by the American Translator’s Association (ATA). All have been tested by us. We provide the translation in Word format along with a PDF of the translation with a signed and notarized certification or affidavit of accuracy. The certification is for IRB or other compliance purposes. We are very active in translations for cancer and other medical research. We are proud to have Icahn School of Medicine at Mt Sinai and Mt. Sinai Hospital, The Tisch Cancer Institute, Intervention Cardiac Research as well as, ProTrials Research, Inc., Covance, Inc., Herbert Irving Comprehensive Cancer Center and Columbia University Medical Center among our clients.
We follow the plain language or low literacy requirements (see Guidelines for ICF translations).
Updates
An ongoing concern in medical research is updates of Informed Consent Forms. For updates we provide a quote based only on the number of new words based on our usual per word price plus a very reasonable flat rate for deletions and handling.
Back Translations
Some sponsors require a back translation for an ICF (also called front to back translation). The English ICF is translated into the target language by one translator. A second translator translates it back into English (without any contact with the original English document). The English back translation is then compared to the original English. A back translation is an added safeguard which allows a sponsor or compliance officer, who only speaks English, to verify the accuracy of the translation. A brief report can also be drawn up (sometimes called a comparative review) comparing the back to English translation with the original English. If we do this in-house, we resolve any issue found through the collaboration of the foreign language translator and the Back to English translator. The source of the error is found and corrected.
Plain Language
The US Food and Drug Administration and the US Department of Health and Human Services require that the writing of Informed Consent Forms be adapted to a level that is understandable to the average person. Our translations follow the same plain language guidelines that were used to write the original English informed consent form. Those who have difficulties understanding English (limited English proficiency patients - LEP. are entitled to assistance in their native language.
HIPAA Compliance
We have a SSL internet security certificate and can be a HIPPA compliant partner for the translation into English of medical records for research or data collection. We can sign a Business Associates Agreement. Even though the patients name and personal information is usually redacted from these records, an extra level of security is a plus. Securely upload your files on this page for a quote or call us about your project.
Covid-19 English-Spanish Terminology / Glossary
Common Errors in English to Spanish Medical Translations
Medical Devices / Medical Equipment / Medical Instrumentation
If you are looking for translations of operating manuals, brochures, advertisement or promotion documents, we can help.
We have experienced translators who provide readable and clear translations of instructions and other materials for all types of medical devices.
Medical Records for Data Collection and Research Purposes
For research professionals or facilitators who need the translation of medical records into English for research or data-collection purposes.
We are experienced in the translation of medical records from all languages into English for research or data-gathering purposes. Recent work includes translation of medical records and test results for participants in clinical trials for individualized treatments of inherited diseases such as ALS. We also create glossaries that are continuously updated to insure quality.
We translate the following medical research documents:
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Relevant Information and Glossary Terms
Back Translation, EPD, ePHI, HIPPA, HRQol, ICF, IRB, LEP, PHI, Plain Language, PRO, Qol,
English Spanish ICF Glossary letter A
