Introduction

Label groups define sets of regions that correspond to the countries and/or languages specified on labeled kits. The use of label groups in a specification ensures that this information is considered when forecasting production quantities and timing.

• Label Group Code and Region Code are always mandatory.

• If any one region appears in more than one label group, Start Date and End Date values are required to ensure they are correctly assigned.

• If there is an overlap in Start and End Dates between any two label groups, Rank values are required to specify the order in which label groups should be used in the Production Plan.

A column with the heading Label Group may also be added to a Planned Lots specification table to correlate planned productions to label groups.

Note: If label groups are not used in a specification the production plan will still show a label group filter. In this case, all productions will be grouped into one ‘default’ label group. This label group will also appear in the interpretation logs.

Label Group table

Label Group Code

Defines the label group. Label group codes have to be unique within a single scenario specification.

Region

Defines the region(s) to which a label group is associated. Must match an existing region specified in the Network Table.

Dispensing Unit Code

Defines which Dispensing Units will use the Label Group. This allows for the same Dispensing Unit to have different Label Groups, if needed. The Label Group requirements can be defined for the entire study or may change over time.

Example 1 , Kit A has a Global booklet label while Kit B requires single panel labels per country.

Example 2, the Label Groups for both kit types changes after a period of time. Japan requires a separate, single-panel label at the start of the study and then is approved to be included in the ROW, Booklet Label after a period of time.

Start Date

Designates when the specified label group is available for dispensing in the defined region(s).

End Date

Designates when the specified label group can no longer be dispensed in the defined region(s).

Rank

Specifies which label group is to be filled first in scenarios where dates or regions overlap. Accepts positive integers only, a label group of rank of 1 will be fulfilled first, 2 will be second, and so on.

If there is an overlap in start and end dates between any two or more label groups that fulfill the same region, rank values are required to specify the order in which label groups should be used in the Production Plan and Trial Supply Projection report.

Example

Label Groups table

Columns in RED are mandatory attributes.