Some Unchecked Seriousness Criteria Are Not Appearing in CIOMS II Output
(Doc ID 2691136.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety - Version 8.1.1 and laterInformation in this document applies to any platform.
Symptoms
When generating CIOMS II listings from Aggregate reports (Reports > Aggregate Reports > CIOMS II Line Listing) and including fields for:
Event Life-threatening, Event Medically Significant, Event Death, Event Hospitalized, Event Disability, Event Congenital Anomaly
In resulting CSV (Comma Separated Values) listing it sometimes contains 'No' for these fields and simply does not contain these fields when no seriousness criteria are selected in the case form -
Why is this ?
Example below:
In the above screenshot only 'Hospitalized' and 'Medically Significant' are selected, all others are unchecked.
However, in the CIOMS II Line Listing report for the same case, two of the unchecked seriousness criteria are shown as 'No', whereas others are not listed at all (null).
Changes
Cause
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In this Document
Symptoms |
Changes |
Cause |
Solution |