All medical organisations know that an Informed Consent Form (ICF) must be signed for any subject who takes part in the clinical trials study and has to be approved by an independent Ethics Committee before being used in the trials. ICFs are provided to disclose all necessary information regarding the research to make sure the participants understand the information provided, and most importantly, voluntarily consent to take part in the study.
In order to ensure that each participant fully understands the information provided, the Informed Consent Form (ICF) has to be presented in the subject’s native language. As a consequence, translating the ICF has become a fundamental step when launching a trial involving patient populations from non-English speaking countries and regions.
The main challenge when translating an Informed Consent Form (ICF) is to produce an accurate, faithful and readable translation which is fully understandable and adapted to the reading levels of the target patient population. As translation errors can change the entire meaning of a phrase to subject participants, it is vital for pharmaceutical organisations to seek the support of medical translation experts who have proven experience in the translation of ICFs and a perfect understanding of its regulatory environment.
At Novalins, we follow strong quality processes when it comes to translating Informed Consent Forms and usually assist companies in the writing of the original document in a level of English that is easily comprehendible and translatable. The medical linguists (medical translators and medical writers) on our team who work with ICFs have a sound knowledge of ICH guidelines as well as the requisite standards and regulatory requirements. For clinical studies intended to meet FDA regulations for instance, we make sure the Informed Consent Forms adhere to the 21 CFR 50.20 requirements.
In addition to offering services for the translation of Informed Consent Forms in over 120 languages, we also assist our customers with the following language solutions: