Dear Forum,
We are running a multinational phase 2 clinical trial under IND in
Israel and the States for an orthopedic application. Part of the CRF
includes a patient questionnaire (IKDC, ICRS and KOOS) score. For the
patients in Israel we wish to translate the questionnaire into Hebrew
to make it understandable to the patients.
Our question is whether at this phase of trial we need to certify the
translation and if so what are the requirements.
Please could you refer us to any source of information on this question.
Thank you very much
Yours sincerely
Ruthy Batish
Quality Assurance & Regulatory Affairs Manager
Prochon Biotech Ltd.
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