Updated auto expectedness assessment

As per EU Clinical Trial Directive (EU CT’3) guidelines, the expectedness assessment must be performed using the datasheet version applicable at the time of occurrence of the event. To comply with this guideline, the Revision # and Active on date (datasheet activation date) fields are now provided in Case Form that enables you to view the datasheet revision number used for Listedness determination.

When the event expectedness is assessed based on a datasheet, the Revision # and Active on date fields are displayed in the following screens:

• Case Form > Events > Event assessment > Data sheet
• Case Form > Events > Event Assessment >Data sheet link > Datasheet Labeled Term popup
• Case Form > Case Actions > Medical Review > Medical Review tab > Event Assessment > Data sheet
• Case Form > Worklist > Local Labeling > Pending and Historical tab > Data sheet
• Local Affiliate > Local Labeling > Pending and Historical tab > Data sheet