COMBINED MEDICAL AND LINGUISTIC EXPERTISE FOR YOUR CLINICAL TRIAL DOCUMENTS

• German Mother tongue speaker, certified English-German translator, M.A. Translation Studies, registered nurse, social worker
• A language and medical professional with many years of experience in patient consultation and writing
• Medical translator and editor of clinical trial materials for over 10 years
• Services in close cooperation with both English and German native physicians, medical editors, graphic designers, and other professional medical translators 

‘Consent documents for oncology trials: does anybody read these things?’ was the provocative title of a study by Sharp (2004, p. 570) on the comprehensibility and length of patient information used in clinical trials for cancer. While the reading level of the average US citizen is at or below 8^th grade, Sharp found that none of the assessed documents was actually written at that level. In Germany, the average reading level is only slightly higher (Rammstedt & Maehler, 2013, p. 28). Given that informed consent forms (ICFs) for a clinical trial are the most important basis for patients´ informed decision-making to participate in such a trial, these results are alarming.

The translation of IFCs as part of a clinical trial is an important work area for translators, and the number of clinical trials as well as the number of trials requiring translation as part of the approval process is on the rise (Penn, 2016, p. 11). Germany, in particular, is one of the most active countries in clinical research (Viomedo, 2016).

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