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vish14184 ★ India, 2008-06-09 16:46 (6183 d 23:10 ago) Posting: # 1931 Views: 6,148 |
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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 -- Edit: Categöry changed. [HS] |
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QA-Clinical ☆ 2008-10-11 10:42 (6060 d 05:15 ago) @ vish14184 Posting: # 2511 Views: 4,583 |
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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 -- Edit: Merged with a later post. You may edit your post within 24 hours! [Helmut] — Diggavi |
Ing. Helmut Schütz