In the Main Summary Tabulation table of the ASR BIP report, the count of SD1 and SD2 is incorrect and not specific (Doc ID 788143.1)

Last updated on JULY 02, 2009

Applies to:

Adverse Event Reporting System - Version: 4.6.1.10 to 4.6.1.15
This problem can occur on any platform.

Symptoms

In the New BIP CTASR (BI Publisher Clinical Trials Annual Safety Report) Summary Tabulations, the report is assigning different drugs to the "Study Drug n" identifier across different studies.

This is not an issue for the summary table within a study because each study has its own Drug Role
table.

However, for the grand totals across the section or entire report this presents a serious problem
because the grand totals are not correct.

Note:

BIP CTASR was introduced as part of AERS iPatch 4.6.1.10, so only appears in this version and higher.


Steps To Reproduce:

For example, in a report with two studies, one with a single Study Drug (DRUG_R) and a second
with two Study Drugs (DRUG_G and DRUG_R),
Study Drug 1 for the first study is identified as DRUG_R, but for the second, DRUG_G is
identified as Study Drug 1 and DRUG_R is identified as Study Drug 2.

This is fine for the Study-specific summary tables, but when the grand totals are calculates, the
DRUG_G cases are included in the "Study Drug 1" column, which is misleading.

These columns need to be identified consistently across all studies so the grand total includes
case counts for a single chemical entity.


Cause

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