Indications Page

The indications for a submission define the symptoms or circumstances that the product is designed to test or treat. Indications can be health problems or diseases identified as benefitting by a therapy being studied in clinical trials. When such a benefit has been established and approved by regulatory authorities, the therapy is approved for the specified indication.

Required access roles: Product Manager or Regulatory User

For a product, the Product Manager manages the indications. For a submission project, the Regulatory Lead for the submission manages the indications.

To access this page for a submission:

Open the required submission. See Opening a Submission.
In the navigation pane, click Regulatory Information.
Click the Indications page tab.

To access this page for a submission master record:

Open the required submission master record. See Opening a Submission Master Record.
In the navigation pane, click Authorizations.
Click the Indications page tab.

To access this page for a product:

Open the required product. See Opening the Regulatory and Additional Details Categories for a Product.
In the navigation pane, click Regulatory.
Click the Indications page tab.

This topic describes:

This page discusses:

Columns
Actions/Toolbar Commands
Creating Indications

See Also

Indication Properties

Editing Properties for Indications

Opening an Indication

Columns


Group Name	Column Name	Description
	Name	The automatically-generated name of the indication.
	Type	The type of object: Indication.
	Title	The descriptive name of the indication.
	State	The current lifecycle state of the indication.
	Indication	The intended use of the product under investigation in a clinical trial or to be authorized by the regulatory authority.
	Description	Descriptive information about the indication.
	Therapeutic Use	Descriptive information about the therapeutic use of the product.
	Target Population	Information about the intended population for this product.
	Target Age	The intended age of the population for this product.
	Gender	The gender to which the indication applies: Male Female All
	Underlying Disease	The disease this product is intended to treat.
Context	Name	The name of an item related to this indication.
Context	Type	The type of the above item, such as Product, Submission Type, and so on.

Actions/Toolbar Commands

The indications list for a submission master record does not provide any actions.


Action Name	Description	For More Information
Copy Existing	Searches for and copies an existing indication to this list. Required access roles in the context of a submission project: Submission project owner or Regulatory Lead	About Searches
Deleted Selected	Deletes the selected indication. Click OK to confirm. Required access roles: Submission project owner or Regulatory Lead	-
Insert New Row	Adds a row to the table so you can create an indication.	Creating Indications
Enable Edit	Toggles the page into edit mode. You must in edit mode to create or edit an indication. 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	-
Disable Edit	Toggles the page into view mode.	-

Creating Indications

Required access roles:

Create indications in the context of a submission project: Submission project owner or Regulatory Lead
Create indications in the context of a product: Product Manager or Regulatory Administrator

Click Enable Edit in the page toolbar.
Click . The app adds a row to the table.
Enter details for each column except the Name column.
Click Save.