Summary

This article describes the standard requirement sets screen where requirement sets can be built and configured.

Table of Contents

• Access Standard Requirement Sets Screen
• Default Fields
  • Associated Bodies Field
  • Name Field
  • Requirements Field
  • Managing Requirements Sets
  • Editing Values
  • Adding and Moving Rows
  • Removing Rows
• Actions
  • Download Structure Template
  • Export This Configuration
  • Load New Requirement Set

The Standard Requirement Sets screen is one location in the system where requirement sets can be built and configured. This is done using the actions provided in the Actions Menu, and some options available in the Requirements field. Requirement sets created on the Standard Requirements Sets screen are used as templates for the components of regulatory submissions that are used when building a study in CTMS. By configuring common requirement sets here, users can easily import them into a new trial without having to recreate the most common components of regulatory submissions.

Access Standard Requirement Sets Screen

The Standard Requirement Sets screen can be accessed by clicking the Add New Set Action available from any regulatory category screen.

Existing requirement sets can be accessed by clicking the name of the set in the Standard Requirement Sets table found on any Regulatory Category screen.

Additionally, existing standard requirement sets can be accessed by clicking the name of the set in the Requirement Sets Manager table.

Default Fields

The Requirement Set form contains the following fields by default:

Associated Bodies Field

The Associated Bodies field is managed by the system and cannot be modified by users. It displays all regulatory bodies that utilize this particular requirement set. When a new set is created this field should only have a single regulatory body listed. However, once a set has been shared between multiple regulatory bodies, all those will be listed here as associations.

Name Field

The Name field is a text field that is used to identify the requirement set within the system.

Requirements Field

The Requirements field will be empty by default and contain a Load Requirements button. Clicking this button will present you with a dialog that will allow you to upload a new requirements template.

Managing Requirements Sets

When requirements have been added to the requirement set, the field will be populated with the structure created by the Load Requirements action.

Editing Values

The fields not set in the structure template loaded to the requirements set will be disabled here as standard requirements are only used as templates. Fields populated in the structure template can be edited via the edit button displayed in the field.

Adding and Moving Rows

Click the Add Row button at the bottom left of the table to insert a new row to the bottom of the table. The new row will display with all enterable fields.

Rows can be rearranged by clicking and holding in any row and dragging up or down.

Removing Rows

Each requirement set will have either a delete or hide option. If the requirement set is not shared between other categories or regulatory bodies, the delete option will be present and clicking it will remove that row from the Requirements field.

If the requirement set is shared by one or more other categories or regulatory bodies, each row of the Requirements field will have a hide option. Clicking the hide icon will remove the row for that requirement set only and will not affect the other shared sets.

Hidden components of a requirement set can be restored by clicking the Restore Hidden button that appears once the form has requirements that you have saved as hidden.

Actions

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

Download Structure Template

Clicking the Download Structure Template will provide the user will a blank Structure Template. These templates are used to define the format of a requirement set. This document can be configured locally and loaded into the requirement set by using the Load New Requirements Action. For more information see Adding and Configuring Requirement Sets.

Export This Configuration

The Export This Configuration action will only be available if the requirements have already been added to the active requirement set. Clicking this action will provide the user with download of a structure template configured in a way that would produce the requirements currently displayed on the screen. This can be used to replicate an existing requirement set or to make small modifications to it. For more information see Adding and Configuring Requirement Sets.

Load New Requirement Set

This Load New Requirement Set action will only be available if requirements have already been added to the active requirement set. Clicking this action will present you with a dialog warning you that loading new requirements will overwrite the set that is currently displayed. Confirming will present you with a dialog to upload a new structure template for the set. For more information see Adding and Configuring Requirement Sets.

Need more help?

Please visit the Fountayn Contact Information page.