Editing Properties for Indications

Users with the appropriate access permissions and roles can edit the details about the indication, such as target population, therapeutic use, and underlying disease.

When an indication is accessed from a submission master record, it cannot be edited.

Required access roles in the context of a submission project: Submission project owner or Regulatory Lead

Required access roles in the context of a product: Product Manager or Regulatory Administrator

Before you begin: View the Properties page for the indication. See Indication Properties
See Also
Indications Page
Opening an Indication
  1. From the page toolbar, click Edit .
  2. Edit these details as needed:

    Field NameDescription
    TitleThe descriptive name of the indication.
    DescriptionDescriptive information about the indication.
    GenderThe gender to which the indication applies:
    • Male
    • Female
    • All
    IndicationThe intended use of the product under investigation in a clinical trial or to be authorized by the regulatory authority.
    Target AgeThe intended age of the population for this product.
    Target PopulationInformation about the intended population for this product.
    Therapeutic UseDescriptive information about the therapeutic use of the product.
    Underlying DiseaseThe disease this product is intended to treat.
    Reason for ChangeReason that the indication for a submission was updated when the submission project is no longer in the Preliminary state, but is not in the Completed, Archived, or Cancelled states.

    This information does not appear on the Properties page for the indication. It is available in the submission's History page.

  3. Click Done.