Go to Reports, and select
Compliance, then select
Periodic, and click Create Unscheduled
Report.
The system opens Periodic Reports dialog box that provides
a list of configured reports of the following types:
PSUR - Containing ICH PSUR Line Listing Reports
IND - Containing US IND Periodic Reports
NDA - Containing US NDA Periodic Reports
CTPR - Containing CT Periodic Reports
Click the (+) icon against the desired category to view
all the reports within that category.
Select the report you wish to create from this list and click
Select.
When the system opens the Report Batch Printing dialog
box, select Run Now or Run at, as
appropriate.
Note:
If you select
Run Now, specify PDF, DOCX, or CSV from the
drop-down list for the report output option to generate the PSUR or CTPR
report in the selected format.
If you select Run
at, specify the date/time to schedule the PSUR report to
be generated by Argus Safety Service. This enables only
Final and disables all other Print
As options.
In the Email field, enter the email ID of the user to
whom the periodic report should be emailed, once completed. By default, this
field lists the email address (if configured) of the current user.
Select what you want printed on the report: Final,
Draft, Internal, or enter
Other information.
Run Using allows users to select between Argus Native
Periodic report and BI Publisher.
Report Form Type allows users to select the Report
Templates and these options are dependent on the value selected in
Run Using. If Run Using is
selected as Argus Native, the Report Form Type drop-down list displays PBRER and
PSUR. The option selected from this drop-down list is used as Report Form Type
for follow-up algorithm.
The options displayed in the Report Form Type are configurable through the flexible codelist Report Template.