IRT drug management is a powerful tool for drug supply teams to leverage for trial supply activities. One of the tools IRT brings to the task of supply management is the label type or label group setting. At times this setting can be confusing because IRT nomenclature can sometimes overlap with clinical supply terminology that has a different meaning. An example of this is an IRT setting of label types that takes a numerical form. Label type 1, as an example, is the first label type that is specified in some IRT systems. Sometimes clinical supply managers can take this to mean label type 1 being reserved for single panel supplies only. This misconception is sometimes also applied to mean that label type 2 in IRT is restricted to double panel label supplies. The reality is that the IRT can be configured to accept label groups in any physical format for any logical label.
The label group setting in IRT controls the countries that supplies may be handled in. This allows clinical supplies managers to funnel supplies to the appropriate countries to which they are labeled for. Most IRTs can support an infinite number of label group settings. This allows supplies to be managed so that sub sets of kits can be reserved for different countries. For example, using label type configuration, you may have a label type that is applied to supplies for South Korea only, and for South Korea, China and Taiwan as well.
This type of function is very useful in cases where a countries regulatory body may change labeling requirements during the course of a trial. In a case like this, the IRT can be configured with a new label type to accommodate a special packaging run. The converse of the scenario above is when a regulatory agency changes requirements to allow supplies previously restricted from the country. In a case like this, the country can be associated with the label group setting that is associated with multiple countries.
Some studies will be able to run their entire lifecycles on one or two label type configurations depending on the countries involved. Others may employ multiple label types to accommodate protocol changes or new countries and regulatory changes. Being aware of the label type setting in IRT will help your study team ensure a steady supply stream to your sites.
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