PBRER QA section
The following information is displayed in the PBRER QA section:
| Section | Description |
|---|---|
|
Case Numbers without any qualifying drugs |
Prints those cases that do not have any products selected in the report configuration. |
|
Case Numbers without any qualifying events |
Prints those cases that do not have any events selected in the report configuration. |
|
Case Numbers considered in Cumulative Summary Tabulations of Serious Adverse Events From Clinical Trials |
Prints all the cases that are part of PBRER Section 6.2. |
|
Case Numbers considered in Numbers of Adverse Drug Reactions by Term from Post-Marketing Sources |
Prints all the cases that are part of PBRER Section 6.3. |
|
Non-clinical cases |
Prints all the non-clinical cases (spontaneous) that are part of the main case series. |
|
Labels configured for drugs in the drug list |
Prints all the datasheets configured from Argus Console for all the products selected in the aggregate report configuration. |
|
Case Numbers with undefined event level seriousness |
Prints all the case numbers that are part of this report, but the seriousness event level is not defined for those. |
|
Summary of Unlocked Cases |
Prints all the unlocked case numbers that are part of this report. It is derived from the Include Summary of Unlocked Cases parameters. |
|
Cases with Missing Assessment |
For more information, see Cases with Missing Assessments. |
QA Section format
For all the above sections, except Cases with Missing Assessment and the labels configured for drugs in the drug list, a list of case numbers, which fall into the respective categories, is displayed in the following format:
For more information, see: