Summary
This article covers the functionalities of the manage requirement screen.
Table of Contents
- Access Manage Requirements Screen
- Available Columns and Filter Types
- Actions
- Choose an Action – Press Go
The Manage Requirements screen provides a high level manager depicting every requirement set currently in a study. Requirement sets can be added here unassociated with any regulatory body or submission, and can be modified later. Additionally, shared standard sets can be loaded into a study from this screen so that the configuration done in the Regulatory Manager does not need to be repeated.
This is an area of the system where a requirement set can be viewed in its full unfiltered state. In the event that a requirement set is shared by multiple submissions, it is possible that within each of these submissions you will only have a view of the subset of requirements that are necessary in that particular submission. By performing data entry from the requirements accessed from the Manage Requirements screen, you can view all requirements that are part of that set absent any filters that are local to a particular submission.
Access Manage Requirements Screen
The Manage Requirements screen can be accessed by expanding the Regulatory sub menu in the study navigation tree, and clicking Manage Requirements.
Available Columns and Filter Types
The Study Regulatory Requirements Manager has many columns that can be dragged and dropped between the manager and filters menu. The values of the Requirement Set, Regulatory Bodies, and Submissions columns serve as links to the records they represent. For more information see the article on CTMS Managers.
The following table defines each column, the actions made available through the column value and the filters and sorts available.
| Name | Value | Action | Sortable | Filters |
| Deleted Status | Indicates if the requirement set is active or deleted | (none) | Yes | Choice |
| Requirement Set | Displays the name of the requirement set. | Links to the associated general purpose requirement set form. | Yes | Text |
| Regulatory Body | Displays the names of the associated regulatory bodies. | Links to the associated regulatory body form. | No | Text |
| Submissions | Displays the name of the associated submissions. | Links to the associated submission form. | No | Text |
| Countries | Displays the countries associated with the requirement set. | (none) | Yes | Choice |
| Status | Displays the cumulative completion status of the requirement set; red if incomplete and green if completed. | (none) | No | Choice |
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.
Add New Set
By clicking the Add New Set action, a blank Add Study Requirement Set form will be provided which, when saved, will add the set to the system. Add New Set is slightly different from the Manage Requirements screen, as it allows the creation of a set without any associated bodies.
Add Standard Set
This action is slightly different than the way it is found elsewhere in the system. By clicking Add Standard Set, you will be presented with a dialog that will allow you to locate and add shared standard requirement sets to multiple submissions at one time.
By selecting multiple regulatory bodies in the Regulatory Bodies Menu, you will be presented with an additional field to select submissions for each of those bodies.
Once submissions are chosen, the Requirement Sets field can be used to find any standard requirement sets shared by the chosen regulatory bodies and select them for addition to the study.
Clicking the Save button will add the chosen standard requirement sets with their preconfigured shared and hidden settings, reducing the amount of configuration needed to set that relationship up.
Exports
By clicking the options Excel or CSV, the system will provide an export of the information currently displayed in the manager table in the chosen format. The content of this export will be based on the filters applied to the table at the time of export.
Choose an Action – Press Go
The Choose an Action – Press Go dropdown can be expanded by clicking and contains the following options.
Deletion
Requirement Sets can be deleted from the study level. If the requirement set is used in an active submission, deleting the set will remove it from the submission. Once removed from the submission to the set would have to be added back to the submission, restoring the set will not re-connect that set to the submission.
To Delete
To delete a study requirement set, the Active Status must be set to Active Only.
- Select the checkbox by the Requirement Set.
- Select Delete Checked in the Choose An Action Press-Go dropdown.
- Select Delete button on the Confirmation Page.
To Restore
To restore a deleted study requirement set, the Active Status must be set to Deleted Only.
- Select the checkbox by the study requirement set.
- Select Restore Checked in the Choose an Action Press-Go dropdown.
- Select Restore Button on the Confirmation Page.
Need more help?
Please visit the Fountayn Contact Information page.