My Oracle Support Banner

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.

Goal

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 ?

 


 

Solution

To view full details, sign in with your My Oracle Support account.

Don't have a My Oracle Support account? Click to get started!


In this Document
Goal
Solution
References


My Oracle Support provides customers with access to over a million knowledge articles and a vibrant support community of peers and Oracle experts.