Product Types in Study Configuration to Support PBRER and DSUR

To support PBRER and DSURs, the Product Type attribute of the Oracle Argus Safety Console Study Configuration page displays the following values along with Investigational Product, Comparator, and Placebo:

• No Study Drug Given: This value lets you classify an event into the No Study Drug Given category if a serious adverse event occurs even before a patient has started taking any study drug.

• Additional Study Drug: These are additional or background drugs that are given as part of a combinational therapy. These drugs are generally given with both investigational products, and comparators. Additional study drugs do not impact the case categorization but are attributes for this configuration in the product temp table.