Summary

This article covers the functionalities available through the study requirement set screen.

Table of Contents

The Study Requirement screen is where data collection for regulatory submissions occurs. Utilizing the tools described in Adding and Configuring Requirement Sets, requirement sets can be designed in a way that allows you to collect all the documentation and related information for the completion of regulatory submissions. It is strongly recommended that you read the section linked above before using study level regulatory features.

Once these structures are built out in the system, you can begin managing your regulatory data collection process in an electronic way that conveys the advantages of auditing, a file manager for uploaded documents, and reduced redundant data entry.

 

Access Study Requirement Set Screen

Study Requirement Sets can be accessed in several ways. The first is by clicking their associated link in the Requirement Sets table found on any submission or amendment form that contains requirement sets.

The second is by navigating to the Manage Requirements screen, and clicking the name link for any requirement set in the table.

Default Fields

The following fields are displayed on the Study Requirement Set screen by default:

Associated Bodies

This is a multiple select field managed by the system. It displays all regulatory bodies in the study that reference all or part of this requirement set. This field indicates whether or not this requirement set is shared between one or more submissions.

Name

The Name field is a text field that is used to identify the study requirement set elsewhere in the system.

Regulatory Requirements Field

This is where the requirement set as it is configured is displayed on the study requirement set form. If there is no set currently provided, this field will be replaced by button labeled “Load Requirements” that will provide you with a dialog to upload a structure template.


Managing Requirement Sets

 

Entering Data

Fields left blank in the structure template will appear enterable/editable. However, fields populated in the structure template prior to loading the Requirements set will appear as plain text / set fields. All fields can be edited. Click the edit icon or click into the editable field to update data.

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.

Deleting Rows

Delete any row by clicking the trash can icon for that row. Once deleted, the row cannot be restored.

Setting Completion Status

Actions

The Actions Menu can be expanded by clicking and contains the following options:
Note: The following actions are described in detail in the Adding and Configuring Requirement Sets section, and it is strongly recommended that this be read.

Download Structure Template

This action provides the user with an excel template from which they may design a new requirement set. Instructions are included within the template.

Export This Configuration

This action allows the user to export an excel spreadsheet that could be used to produce the requirement set configuration currently saved for the study requirement set. This action can be used in the event that you would like to create another similar or identical requirement set elsewhere in the system.

Export Values

Export Values will provide you with an excel spreadsheet containing the values currently stored in the requirement set. The structure of the table in the spreadsheet will match the current configuration of the requirement set, and any fields that should not be altered will be locked by default. Data entry-capable fields will be left open.

Import Values

Import Values will provide you with a file upload that will allow you to import an excel spreadsheet in the configuration that would be provided by the Export Values action. If the structure of the import is as expected, any values in the table will be overwritten with those provided in the import. If the system detects that the structure of the import is changed, the import will fail.

Load New Requirements

Load New Requirements will provide you with a file upload that accepts a structure template. This will allow you to redesign the structure of your requirement set. Be warned, however. Uploading a new structure template will cause any data saved in the requirement set to be lost, as the old set is destroyed. It is recommended that you first Export Values in order to preserve any data prior to redesigning the requirement set.


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