6 Secure Unblinding in AM

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

The value for some of the table columns in AM is dependent upon the selection of the Study is eligible for Unblinding checkbox, which is present in Studies Configuration under the Business Configuration section in Argus Safety, as shown in the following figure:

Figure 6-1 Study is eligible for Unblinding Checkbox in Argus Safety

If the Study is eligible for Unblinding checkbox is checked, the actual values for all the blinded columns is displayed in AM tables.

However, if the Study is eligible for Unblinding checkbox is not checked, the actual values for all the blinded columns are replaced by NULL, Blinded, or any other value in the AM 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 checkbox is checked.

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 checkbox is checked.