Is the native language Informed consent can be generated independently rathertranslating from English?
CHP: Of course, it should or would make no difference what the language is that the SP gets except in the IC but that the SP MUST be fluent in that language. From the language of the ICF one would most likely need an English translation. An exception out this would be if you were given an ICF by the Sponsor in English. This would then need to be translated into the first (main) language of the SP and the burden of proof that the translation is accurate rests with the PI – it is her/his responsibility. 28. Is it necessary to have DSMB for BE study?(It is not mentioned anywhere in the guidelines for BA/BE study). CHP: Most likely the answer is No. BA/BE studies are 1) done at one site, 2) are relatively of short duration, and 3) test a known drug which has been on the market with a copy drug.
Related Questions
- English is not my native language, but Ive been living and taking classes in an English-speaking country for quite a while. Do I nevertheless need to submit a TOEFL score?
- Can the requirement to submit GRE and TOEFL (for applicants whose native language is not English) scores be waived?
- Is the native language Informed consent can be generated independently rathertranslating from English?
