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EVAERS: Issue With DTD_LENGTH For ACTIVESUBSTANCENAME (Doc ID 2408443.1)

Last updated on FEBRUARY 25, 2019

Applies to:

Oracle Argus Safety - Version 8.1.2 to 8.1.2 [Release 8.1]
Information in this document applies to any platform.

Symptoms

For the eVAERS profile , DTD_LENGTH for ACTIVESUBSTANCENAME in CFG_E2B table is mentioned as 100, whereas in the mapping code within ACTIVESUBSTANCE DTD Element, it allows up to 250 characters for ACTIVESUBSTANCENAME.

As per eVAERS FDA guideline and ICH guidelines, 250 characters are allowed for ACTIVESUBSTANCENAME DTD Element.


But currently as DTD_LENGTH in CFG_E2B table is only 100 characters, users are not able to send more than 100 characters in this element.

Cause

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In this Document
Symptoms
Cause
Solution
References


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