Summary
This article covers accessing and adding regulatory bodies to the study.
Table of Contents
The Study Regulatory Bodies screen contains a simple manager table that displays all regulatory bodies that have been added to a given study. From this screen the user may select from regulatory authorities that have been created in the Regulatory Bodies Manager that operate in the countries selected for the study.
Access Study Regulatory Bodies
From within a study in CTMS, expand the Study navigation tree and locate the Regulatory sub menu. Expand the Regulatory option and select Regulatory Bodies.
Available Columns and Filter Types
The Study 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 |
| 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 | |
| Contacts | Displays the main contacts 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 Bodies
By clicking the Add Regulatory Body Action, you will be presented with a dialog to select new regulatory bodies to add to the study.
Study Country
By selecting a country in this field you can filter the options displayed in the Regulatory Bodies field.
Regulatory Bodies
By selecting from options displayed in this field, you can select one or more regulatory bodies to add to the study by clicking the Save button.
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
Regulatory Bodies can be deleted from the a study, during the deletion process all submissions for the body will also be deleted. If any site or submission has been associated to the body, the body will be removed from the site and submission. Once deleted the body cannot be restored.
To Delete
To delete a regulatory body.
- Select the checkbox by the body record.
- Select Delete Checked in the Choose an Action Press-Go dropdown.
- Select Delete button on the Confirmation Page.
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