INFORMATION MODEL MANAGEMENT
Information modeling in the platform consists of configuring the underlying metadata model and defining the controlled terms and metadata coming from external master sources. The modeling also includes information models that define the structure and policies for any type of information managed in the platform, such as a document (i.e., a compilation of related components such as a clinical study report) or a dossier (i.e., a compilation of related documents such as a marketing application submission).
METADATA MODEL CONFIGURATIONS
The platform provides the capability to configure and manage metadata models to support business needs. The metadata model is used to classify all objects, such as components, documents, and dossiers managed in the system, to enable auto-population of content within a document or dossier, and to bind document templates so that authors can populate valid term values while authoring the document.
Metadata models can be created as follows:
Metadata terms and term values can be created and used as follows:
INFORMATION MODEL CONFIGURATIONS
Information models allow permitted users to configure the structure of the document components and define element/ component level content policies, such as:
Elements within the information model can be content components and metadata variables.
Information models are configured for each type of structure (e.g., document, dossier) to be supported within the platform.
Any related instructional text can also be configured and is kept separate from the document template itself.