Clinical trials are usually conducted in several countries. The labeling of investigational medicinal products has to accommodate an increasing number of languages. Labels may have to be printed in different versions since each country should have its own label.
Clinical Supplies Management module allows to manage the association of specific countries and languages combinations to clinical labels to generate and print the appropriate label design for the countries involved in the clinical study.
Language sets
In the Language sets form (Clinical Supplies Management > Setup > Languages > Language sets), users can create language sets and enter the corresponding description. The Languages button allows to open the Languages by language set form filtered for the selected language set and to add/remove languages.
Example
Language set: “BEL – Belgium”
Languages by language set: “English (United Kingdom)”, “French (Belgium)”
Languages by language set
In the Languages by language set form (Clinical Supplies Management > Setup > Languages > Languages by language sets), the system displays the full list of languages associated with their language set.
It is possible to associate one or more languages to a language set.
Language sets by country/region
In the Language sets by country/region form (Clinical Supplies Management > Setup > Languages > Language sets by country/region), users can associate a country/region with one or more language sets. For example, the “BEL” country (Belgium) can be associated with the “BEL” language set.
In the Released products form, users can specify which language sets by country/region are applicable for the selected item by using the Language sets by country/region button (Product information management > Products >Released products > Clinical Supplies Management tab). The full list of language sets by country/region is available; one or more of them can be assigned to the item by enabling the Select checkbox. If multiple language sets are associated with the same country/region, only one is selectable for the same item.
Languages and country inquiries
It is possible to inquire the full list of languages and their descriptions in the Languages form (Clinical supplies > Inquiries > Languages > Languages). It is not possible to add/delete languages from the list.
It is possible to inquire the full list of countries and their descriptions in the Countries form (Clinical Supplies Management > Inquiries > Languages > Countries). It is not possible to add/delete countries from the list. The Language sets button provides a direct link to the language set by country/region form, filtered by the selected country.