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Queries Around Report Mapping Logic For US FDA VAERS Form - Some fields are printing UNKNOWN (Doc ID 2625566.1)

Last updated on JUNE 09, 2020

Applies to:

Oracle Argus Safety - Version 8.2 and later
Information in this document applies to any platform.

Goal


Queries around report mapping logic for US FDA VAERS Form

After validating US FDA VAERS form it was noted a few discrepancies which are not explained in the Report Mapping Document (Reports TRM). Examples below:

1. Field 'PATIENT NAME FIELD'

This Field in Report Form has below detailed description in TRM:



If empty, this currently prints “Unknown”, however this is not mentioned in TRM notes above.

 

2. VACCINE ADMINISTERED BY NAME FIELD
 

This Field in Report Form has below detailed description in TRM:

If empty, this currently prints “Unknown”, however this is not mentioned in TRM per above.

 

3. VACCINE ADMINISTERED BY RESPONSIBLE PHYSICIAN FIELD

 

This Field in Report Form has below detailed description in TRM:

If empty, this currently prints “Unknown”, however this is not mentioned in TRM per above.

 

4. VACCINE ADMINISTERED BY FACILITY NAME/ADDRESS FIELD

 

This Field in Report Form has below detailed description in TRM:

If empty, this currently prints “Unknown”, however this is not mentioned in TRM per above.

 

5. VACCINE ADMINISTERED BY PHONE FIELD

 

This Field in Report Form has below detailed description in TRM:

If empty, this currently prints “Unknown”, however this is not mentioned in TRM per above.

 

6. REPORTER STATE FIELD

 

 This Field in Report Form has below detailed description in TRM:

Currently it is coded by design to set this to "Unknown" when no data provided (and protect confidentiality unchecked), however this is not mentioned in TRM per above.

 

7. COUNTY WHERE ADMINISTERED FIELD

 

This Field in Report Form has below detailed description in TRM:

If empty, this currently prints “Unknown”, however this is not mentioned in TRM per above.

 

8. PATIENT AGE FIELD

This Field in Report Form has below detailed description in TRM:

 

9. DATE OF VACCINATION FIELD

This Field in Report Form has below detailed description in TRM:

In above there is no mention of value in form when no data is supplied for this field (date or time)

Currently this populates as "UNKNOWN" by design per other fields

 

10. ADVERSE EVENT ONSET FIELD

 

This Field in Report Form has below detailed description in TRM:

 

However no mention of value in form when no data is supplied for this field (i.e. neither date or time)

Currently this populates as "UNKNOWN" by design per other fields

 

11. VACCINATED AT FIELD

This Field in Report Form has below detailed description in TRM:

However no mention of value that should be in form when no data is supplied for this field

Currently this populates as "OTHER/UNKNOWN" by design per other fields

 

12. PURCHASED WITH FIELD

 

This Field in Report Form has below detailed description in TRM:

However no mention of value that should be in form when no data is supplied for this field

Currently this populates as "OTHER/UNKNOWN" by design per other fields

Solution

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In this Document
Goal
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