Adding and editing a drug

Your organization chooses drugs to monitor for signal management. For non-interactive signal configurations, Oracle creates the list of monitored drugs during preparation of the signal management data. Additionally, users with the Manage Signaling Terms user permission can add to and edit the list.

Note: After a drug is added manually, the next safety data update includes that drug if it is for an AERS-based, VAERS-based, or Vigibase-based signal management implementation. To ensure that an added drug for a customer-specific signal management implementation is included in periodic safety data updates, contact Oracle.

1. Click the Signals tab.

2. Click Drug Overviews.

The Drug Overviews page appears.

3. To add a drug:

A. Click Add Drug.

The Add/Edit Drug window appears.

B. Fill in the fields.

C. Click Save.

4. To edit the details for a drug:

Note: You can rename a drug only if the signal configuration is interactive. For more information, see Renaming a drug.

A. In the table, locate the drug to edit.

B. Click the row menu () for the drug, and then click Edit.

The Add/Edit Drug window appears.

C. Edit the fields.

D. Click Save.

Field descriptions

Field	Description
Drug	Unique name of the drug. For interactive signal configurations, you can select terms from a list using the following links: Select <hierarchy> Terms—Appears if the drug is associated with a hierarchy such as the Anatomical Therapeutic Chemical (ATC) Classification System. For more information, see Selecting hierarchy terms. Select Available Value—Displays valid drug names. For more information, see Selecting values from a list.
Review period	Frequency that evaluations are expected to take place for this drug, for example, every 3 months, 6 months, or 1 year. This field is required if an administrator set up the Review Period feature for the signal configuration.
Default view	Name of the signal view associated with the drug. When the drug is selected in the Drug field on the Drug-Event Combinations page, this view is used for the drug by default. If there is a default view for signal management, select -- in this field to specify that view. If an administrator set up the Review Period feature for the signal configuration, the view assigned to the drug is typically for the same time interval so that the scores, counts, and other data shown on the Drug-Event Combinations page for this drug reflects information received since the last review.
Drug group	Group associated with the drug. To select an existing group, click Select from existing groups and select from a list of groups. To add a new group, click Add new group and type in a group name. Note: Drugs, not reviewers, belong to groups.
Reviewers (optional)	Names of individual reviewers assigned to the drug. Click Add Reviewers From List to select reviewers from a list. If the drug is marked as participating in automatic assignment of reviewers, you can specify only one reviewer. If there is already a reviewer assigned to the drug, you can select no reviewer (--) to remove the assignment. Reviewers available for assignment are users in login groups to which the signal configuration is assigned.
Participates in automatic assignment	Whether the drug is eligible for automatic assignment of reviewers. This option is only available if the Allow Automatic Assignment of Reviewers to Drugs site option is enabled.