Bioequivalence and Bioavailability Forum

Dear All,

gujarati and English ICF both IRB approved.

Now, During ICF presentation in vernacular language identify that in gujarati (Vernacular language) ICF some information are missing. These details available in English ICF.

This is Translation error for that Generate errata and inform to Volunteers regarding that and send copy of errata to IRB.

Now, I want to know that,

IS it Acceptable to generate errata? or we should amend Gujarati ICF and need IRB approval.

Thank you

Regards
vishal Nakrani

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Edit: Categöry changed. [HS]