Bioequivalence and Bioavailability Forum

Dear Vish,

I know this reply comes after a reaally long time since you posted your question, but better late than never!

Errata is used when there are typographical errors / omissions while if the data mismatch between the gujarati and English ICFs consists of information that affects the safety and rights of the subjects then you should go in for an amendment with due approval from IRB/IEC.

Errata can also be used for administrative changes or mismatch.

I would like to suggest that the ICFs of English and the vernacular languages be reviewed before sending for IEC Approval.

Also, weren't the ICFs sent for translation and back translation? I feel this could have been avoided at that stage itself. The second checkpoint would be when ICFs are sent to IEC for review.


Hope this helps.

Regards,
QA-Clinical

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Edit: Merged with a later post. You may edit your post within 24 hours! [Helmut]