Use any one of the following options to generate reports:
Generating from the AER List page:
To generate summary reports, without opening an AER, select the desired report from the Report menu.
To generate a single case report, open the AER and select the desired report from the Report menu.
Generating from the Workflow Status page:
Select the case
From the Reports/Listings/Management reports/Ad hoc reports/Others menu options, select the required report.
The Report is generated based on the criteria selected.
Based on the report type selected in the Run time reports window, you generate blinded and unblinded reports from the workflow caselist for (a) FDA 3500A (b) CIOMS I and (c) AER data.
Overview Report
To generate a report for the selected cases, click the Overview button.
The Overview Report is displayed as a PDF file.
Note: Refer to the Overview Report Reference guide for details.
Comparison Report
Select any two versions of the case that you want to compare.
To generate the Comparison Report, Click the Generate button.
The Differences appear in the MS-Word.
Difference Report
In the Workflow Status page, select a case which has more then one verison.
To display the differences between two case versions in a textual form, Click the Difference button.
The report appears.
Did you find this page helpful?