Inclusion of additional blinded fields in the case

Summary

Inclusion of additional blinded fields in the case form (Enhancement 35969341)

Description

Case blinding feature is enhanced to blind additional fields in a case form for a blinded study case and for users who have checked the Protect from Unblinded Information check box.

Additionally, blinded fields are masked in the print case form reports, if you have checked the Protect from Printing Unblinded Information check box in Argus Console > Users.

The following fields are masked with blinded text in the case form and case form print reports:

• Product > Vaccine > Vaccine Information > Batch / Lot Number
• Product > Product Information > Obtain Drug Country, Drug Authorization Country, Market Authorization Holder, Manufacturer
• Event Assessment > Data Sheet/License column

If the Protect from Unblinded Information check box is unchecked, then the above mentioned fields are displayed with data in the case form for both the blinded study case and unblinded case.

In the MedWatch report, C1[Manufacturer/Compounder Name] mapping is updated to display blinded text when blinded conditions are satisfied. For more information, refer to ArgusSafety8.4.4_MWPaperReportMappings.xlsx.