> Informed Consent Forms
You are a clinical research professional or facilitator and you need the translation of an Informed Consent Form into the language of a research participant.
We have experienced medical translators in many language pairs - including the most requested English to Spanish - with a proven track record. Most of our translators are certified by the American Translator’s Association. 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 for IRB or other compliance purposes. We are very active in translations for cancer research and 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 ICAP at Columbia University Medical Center among our clients.
Updates of Informed Consent Forms is also on ongoing concern in research. We update our translations based on a quote that includes the usually per word price for the addition texts plus a very reasonable flat rate for deletions and handling.
We have recently initiated a new process which involves two edits of ICF translations. Each edit has specific guidelines to insure there are no mistranslations or omissions and to meet the plain language or low literacy requirements (see Guideline for ICF 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.
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. We follow guidelines for ICF translation: (http://www.languagescientific.com/language-services-blog/6-things-to-know-about-informed-consent-form-translations.html). Those who have difficulties understanding English (limited English proficiency patients - LEP) are entitled to assistance in their native language.
> Medical Records for Data Collection and Research Purposes
You are a clinical research professional or facilitator and you need the translation of medical records into English for research or data-collection purposes.
For the translation of medical records from all languages into English for research or data-gathering purposes, we organize our translators into communicating teams in the relevant language pairs and create glossaries that are continuously updated to insure quality.
We translate the following documents
- Informed Consent Forms (ICF)
- Investigator's Brochures
- Ethics Committee Documentation
- Clinical Trials Agreements
- Clinical Trials Authorizations
- Serious Adverse Events Reports
- Medical Records for Research
- Patient Safety Cards
- Clinical Trial Protocols
- Patient Information Sheets (PIS)
- Case Report Forms (CRF/eCRF)
- Patient Diaries
- Patient Reported Outcomes (PRO/ePRO)
- Quality of Life Questionnaires (QoL)
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 will sign a Business Associates Agreement. Even though the patients name and personal information is redacted from these records, an extra level of security is a plus. You can securely upload your files on this Medical page.
Click and securely upload your document(s)
Among our Clients