Performing Local Labeling

Select Local Labeling from the Local Affiliate menu to open the Local Labeling screen.

Select Pending to view cases that are waiting for labeling.

Pending Tab Field Information

The following table lists and describes the fields on the Pending tab.

Field	Description
LAM Event Number	Displays the LAM event number. The link displayed in this field helps you in viewing event information.
Case Number	Displays the case number with Central.
Product	Displays the name of the primary suspect product.
Event PT (Description) / LLT	Displays the name of the primary event.
D/S	Displays if the event was diagnosis or symptom.
Seriousness	Displays all the seriousness criteria for the event.
Severity	Displays the severity for the event.
Duration	Displays the duration for the event.
Datasheet	Displays the datasheet(s) and its corresponding revision number and activation date that were used in assessment of the product and the event.
License	Displays the license(s) for the agent.
Listedness	Displays the listedness of the drug. Values may include Listed, Labeled, Unlisted, Unknown.
Marked as Assessed	Allows the user to mark whether local assessment is done against the licenses displayed for the product or not. It provided 3 methods to mark this status at 3 different levels. 1) Assessed checkbox at License Level: This checkbox allows users to specify the local assessment status at each license level. It shall be available in both Pending and Historical tabs. 2) Assessed checkbox at Database Level: This checkbox allows users to specify the local assessment status at each datasheet level. If user checks or un-checks this checkbox, it shall automatically update all the license level checkboxes under this datasheet accordingly. It shall be available in both Pending and Historical tabs. 3) "Assessed" button at Product Level: Clicking on this button shall mark all the licenses and datasheet level checkboxes as checked. It shall only be available on Pending tab.

Select Historical to view cases that have been assessed.

Historical Tab Field Information

The following table lists and describes the fields on the Historical tab.

Field	Description
LAM Event Number	Displays the LAM event number. The link displayed in this field helps you in viewing event information.
Case Number	Displays the case number with Central.
Product	Displays the name of the primary suspect product.
Event PT (Description) / LLT	Displays the name of the primary event.
D/S	Displays if the event was diagnosis or symptom.
Seriousness	Displays all the seriousness criteria for the event.
Severity	Displays the severity for the event.
Duration	Displays the duration for the event.
Datasheet	Displays the datasheet(s) and its corresponding revision number and activation date that were used in assessment of the product and the event.
License	Displays the license(s) for the agent.
Listedness	Displays the listedness of the drug. Values may include Listed, Labeled, Unlisted, Unknown.
Marked as Assessed	Allows the user to mark whether local assessment is done against the licenses displayed for the product or not. It provided 3 methods to mark this status at 3 different levels. 1) Assessed checkbox at License Level: This checkbox allows users to specify the local assessment status at each license level. It shall be available in both Pending and Historical tabs. 2) Assessed checkbox at Database Level: This checkbox allows users to specify the local assessment status at each datasheet level. If user checks or un-checks this checkbox, it shall automatically update all the license level checkboxes under this datasheet accordingly. It shall be available in both Pending and Historical tabs. 3) "Assessed" button at Product Level: Clicking on this button shall mark all the licenses and datasheet level checkboxes as checked. It shall only be available on Pending tab.

Enter the Case Number, if it is known.

Click Search to view the list of events, grouped by the Local Event Number.

Under Local Labeling, select the appropriate labeling for each product associated with the event.

Select the Assessed checkbox for the labeled case and click Mark as Assessed to mark the selected case for a Preferred Term. The system enables the Process button.

Click Process to save the labeling changes.

The selected report is displayed in a PDF.