Additional Values for FDASAFETYREPORTTYPE A.1.FDA.16 (FDA Safety Report Type) (Doc ID 2750978.1)

Last updated on MAY 18, 2021

Applies to:

Oracle Argus Safety - Version 8.1.2 and later
Information in this document applies to any platform.

FDA E2B DTD Descriptor 2.1

There is a new requirement to output the value of A.1.FDA.16 (FDA Safety Report Type) with below values:

A.1.FDA.16 <fdasafetyreporttype>

1=IND Safety Report
2=IND Exempt BA/BE Safety Report
3=Postmarketing Safety Report

Per https:/www.fda.gov/media/132096/download
Page 3

Question: Is this implemented in any Argus Version as yet ?

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