Summary
This article covers the uses of the regulatory bodies manager including the storage and tracking of regulatory authorities.
Table of Contents
- Access Regulatory Bodies Manager
- Available Columns and Filter Types
- Actions
- Choose an Action – Press Go
The Regulatory Bodies Manager allows for the storage and tracking of regulatory authorities stored in the system. The Regulatory Manager gives a high level view of those currently stored in the system and provides easy access to contact information for those Regulatory Bodies. Regulatory Bodies created here will be available to associate with new studies when they are created. This forms the basis of our Regulatory Submission management process.
Access Regulatory Bodies Manager
From within the CTMS platform, click the expandable menu to the left of the screen. Expand the Regulatory option and select Regulatory Bodies.
Available Columns and Filter Types
The Regulatory Bodies Manager has many columns that can be dragged and dropped between the manager and filters menu. The values of the Regulatory Bodies and Contacts 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 regulatory body is active or deleted | (none) | Yes | Choice |
| Regulatory Body | Displays the name of the regulatory body. | Links to the associated Regulatory Body form. | Yes | Text |
| Countries | Displays the countries associated with the regulatory body. | (none) | Yes | Choice |
| Displays the contact e-mail for the regulatory body. | (none) | Yes | Text | |
| Contact | Displays the main contact for the regulatory body. | Links to the Personnel form for the main contact. | Yes | Choice |
Actions
The Actions Menu can be expanded by clicking and contains the following options:
Add Regulatory Body
By clicking the Add Regulatory Body Action, you will be directed to a new Regulatory Body form that can be saved to add a new record to the manager.
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
A regulatory body can be deleted and restored through the Regulatory Bodies Manager.
- If a regulatory body has been added to a study, the regulatory body cannot be deleted from the manager. The regulatory body must be removed from the study before the body can be deleted.
- If a regulatory body has requirement sets assigned, the requirements sets must be deleted before the body can be deleted.
- If a regulatory body has a submission associated at a site the submission must be removed from the body before deletion is allowed.
To Delete
To delete a regulatory body, the Active Body Status must be set to Active Only.
- Select the checkbox by the Regulatory Body record.
- Select Delete Checked in the Choose An Action Press-Go dropdown.
- Select Delete button on the Confirmation Page.
To Restore
To restore a deleted regulatory body, the Active Body Status must be set to Deleted Only.
- Select the checkbox by the Regulatory Body record.
- Select Restore Checked in the Choose An Action Press-Go dropdown.
- Select Restore button on the Confirmation Page.
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