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Informed Consent Forms Translation
Informed Consent Forms (ICFs), setting out information about a clinical trial and its
conduct, are essential in gaining the patient’s written consent to participate in the trial by
signing the document. The guidelines used to create ICFs are based on medical ethics
and research ethics, requiring that "the information that is given to the subject or the
representative shall be in language understandable to the subject or the representative."
It is mandatory to help the non-English speaking population understand ICFs' content in
the native language. Accurate, legible, understandable, and honest translations of ICFs
for the target language population are indispensable to carry out the medical procedures
or clinical trials.
Detailed Information Included in ICFs
Patients' or participants' physical condition
Treatment or research requirements
Essential design elements of the trial
Risks and benefits of procedures
Agreement between the patient/participant and the clinical team
Conform to the recommended standards and guidelines for ICF documents.
Prepare high-quality source documents, or get FDA/IRB approval of all English texts.
Use professional translators with a solid life science background.
Identify the patients'/participants’ native language(s) prior to submitting informed
consent documents for translation.
Implement localization strategies, such as preparing the translated Informed Consent
Form in a right to left reading format, changing numerical and currency formats,
culturally sensitive explanations for parts of the trial, etc.
Back translation for Quality Control of Informed Consent Forms
As a language service provider with an extensive understanding of clinical trials,
MedTrans provides ICFs translation service to ensure that patients/participants
understand what is involved in the planned clinic