Please clarify re: patient reported outcome (PRO) instruments: 1) Post translations whose responsibility is it to validate the translated version of the questionnaire? 2) Could the translated version be submitted to the regulatory authority without validation? 3) Whose responsibility is it to submit the translated questionnaire post validation? 4) If any modification is done in the validated translated version then is there a requirement to validate the modified version and then submit the same to the regulatory authority? 5) What if a translated questionnaire is used without validation considering a situation where only English document has been submitted to the regulatory authorities and the translated version have only been submitted to the respective Ethics Committees? Garima Singh For 1) & 3) - FDA has released a guidance on PRO in Dec 2009. It is addressed to sponsors. Hence, they are responsible for validation of the PRO instrument - both English as well as t...
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