Summary

This article covers the features of the add regulatory category screen.

Table of Contents

• Access Add Regulatory Category Screen
• Default Fields
  • Name Field
  • Comments Field
• Standard Requirement Sets Table
• Actions
  • Add New Set
  • Share Existing Set

Regulatory categories are simple groupings used to identify different standard requirement sets when they are being added to a study. By defining regulatory categories associated with therapeutic areas or trial types, users can easily locate regulatory submission requirements commonly requested by a given regulatory body for that particular variety of trial. By default these categories only have a name and a comments field, and as they are static forms, they are not configurable from CTMS Settings.

Access Add Regulatory Category Screen

The Regulatory Category screen can be reached from the Regulatory Body screen by clicking the Add Regulatory Category Action.

Additionally, any existing regulatory category can be accessed by clicking its name in the Regulatory Requirements Manager Table.

Default Fields

The Regulatory Category form contains the following fields by default:

Name Field

The Name field is a text field used to identify the regulatory category. The Name field is a required field and a black alert will fire if the name is not provided and the form cannot be saved until the name is entered.

Comments Field

The Comments field is a text field that can be used to store any relevant reference information regarding a particular regulatory category.

Standard Requirement Sets Table

The Standard Requirement Sets table lists all requirement sets that have been added to the regulatory category alongside a delete icon that can be used to remove the set. Clicking on the name of a requirement set will direct you to the standard requirement set screen for that set. Clicking the delete icon beside any requirement set will provide you with a confirmation dialog to delete that set.

Actions

The Actions Menu can be expanded by clicking and contains the following options:

Add New Set

Clicking the Add New Set option will create a new requirement set within the regulatory category and direct you to the Standard Requirement Sets screen for that set.

Share Existing Set

Clicking the Share Existing Set option will provide you with the Share Existing Requirement Set Dialog to select which existing requirement set you would like to add to the current regulatory category. For more information regarding sharing requirement sets between regulatory bodies, categories and submissions, see the article on Sharing Requirement Sets.

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