12 Secure Unblinding in Oracle Argus Mart

This chapter explains the concept of Blinded Security for certain table columns in Oracle Argus Mart for a drug study.

The value for some of the table columns in Oracle Argus Mart is dependent upon the selection of Business Configuration > Studies Configuration > Study is eligible for Unblinding check box, in Oracle Argus Safety.

Studies Configuration screen

If the this check box is selected, the actual values for all the blinded columns is displayed in Oracle Argus Mart tables.

However, if this check box is not selected, the actual values for all the blinded columns are replaced by NULL, Blinded, or any other value in the Oracle Argus Mart tables.

In case of the Reporting Mart, there are three views which comprise the Blinded information: v_rm_su_case_product, v_rm_su_case_prod_drugs, and v_rm_su_case_dose_regimens. These views display the actual data only if the Study is eligible for Unblinding check box is selected.

Similarly, in case of a Signal Mart, there are certain table columns which comprise the Blinded information. The name of these columns end with _su, which represents Secure Unblinding. These table columns display the actual data only if the Study is eligible for Unblinding check box is selected.