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Subject: eTMF metadata vocabulary comments
1)
C115691; C115480; C115608; C115609; C11550 should be categorized by country and not by Trial. 2)
C115692 IRB-IEC Tracking document. Process tracking is not a required TMF document. Consider removing 3)
C115586 –Pre Trail Monitoring Report – Add Pre Trail Monitoring Report Waiver to the synonyms 4)
C115576 – Trial Initiation Monitoring Report – add Trial Initiation Monitoring Report waiver to the synonyms 5)
C80447 – include electronic signature as well 6)
C80447 – include electronic signature as well |
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