Ennov InSight IDMP 7.3

IDMP Data Visualization Attributes for SPOR Values

The names of the nodes used to indicate additional data and represent specific attributes or meanings and their display rules.

Note: If an entity selected does not have SPOR values associated in Data Administration, there will be no values for this entity field on the Data Visualization page. Select the icon next to the field to view the information.

For example, to display the values for the Orphan Designation Status field on the Data Visualization page, associate the term from the RMS tab in Data Administration > Orphan Status Values.

All the SPOR values are displayed in the following format: <Term Name>/<RMS Term ID>/<Status>.

All the OMS values are taken from Data Administration > SPOR Master Lists > Organization. For example, to display the values for the Marketing Authorisation Holder (Organisation) field on the Data Visualization page, associate the term from the OMS tab in Data Administration > MAH/Development Sponsor/Organisation Values.

The following is the Data Visualization hierarchical structure:

Medicinal Product

  • PMSID, Medicinal Product Name
  • Marketing Authorization 
  • Manufacturer/Business Operation
    • Operation Type, Manufacturer, Active Ingredient
  • Therapeutic Indications
    • Indication, Intended Effect
  • Medicinal Product
    • Marketing Authorisation Number, Pack Size
  • Manufactured Item
    • Manufactured Dose Form, List (Active Ingredient + Strength)
  • Certificate Master File
    • File Identifier Type : File Identifier, Substance Name
  • Pharmaceutical Product
    • Administrable Dose Form, List (Active Ingredient + Strength)