Why the Case is Displayed Twice in the NDA Periodic Report Once in the S/L Section and Again in the S/UL Section?
(Doc ID 1159472.1)
Last updated on JULY 10, 2019
Applies to:Oracle Argus Safety - Version 188.8.131.52 and later
Information in this document applies to any platform.
Why is the case displayed twice in the NDA periodic report--once in the S/L section and again in the S/UL section in the following scenario?
Scenario: The case was initially reported to the FDA as a Serious Unlisted case within the Periodic report time frame. Follow-up information was received and the case was downgraded to a Serious Listed case. The downgrade occurred outside of the reporting time frame. The NDA report now list the case twice. Once in the S/L section and again in the S/UL section.
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