Summary
This article covers the functionalities of the deviation manager.
Table of Contents
The Deviations Manager stores records and tracks activity of all deviations associated to studies. The Deviation Manager gives a high level view of all study deviations and provides an easy view of select information for the deviation, making it easier to identify deviation trends and deviations needing transitions.
Access Deviation Manager
The Deviations Manager can be access two ways:
From within the CTMS platform, click the expandable menu to the left of the screen, select Deviations.
Available Columns and Filter Types
The Deviation Manager is comprised of columns that can be dragged and dropped between the Manager and Filters Menu. The values of the Description of the Deviation column serve as a link 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 options.
| Name | Value | Action | Sortable | Filters |
|---|---|---|---|---|
| Active Deviation | Indicates if the deviation record is active or deleted. | (none) | Yes | Choice |
| Study | Displays the study protocol. | (none) | Yes | Choice |
| Description of the Deviation | Displays the city of the vendor. | Links to the Deviation form for the record. | Yes | Text |
| Date of Deviation | Displays the date of the deviation. | (none) | Yes | Date |
| Site | Displays the site name as listed in the Sites Manager. | (none) | No | Choice |
| Deviation Category | Displays the deviation category. | (none) | Yes | Choice |
| Action Taken | Displays the action taken due to the deviation. | (none) | Yes | Text |
| Transition Status | Displays the current status of the deviation. | (none) | Yes | Text |
| Study Site | Displays the Study Site Name | (none) | No | Text |
| Created by | Displays the author of the deviation. | (none) | No | No |
| Submitted | Submitted Date as determined by the approval workflow | (none) | Yes | Date |
| Finalized | Finalized Date as determined by the approval workflow | (none) | Yes | Date |
| Study Status | Displays study status. | (none) | Yes | Choice |
| Sponsor | Displays the Name of the Sponsor. | (none) | Yes | Choice |
| CRO | Displays the Name of the CRO. | (none) | Yes | Choice |
Actions
The Actions Menu can be expanded by clicking and contains the following options.
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
Deviations can be deleted and restored through the Deviation Manager.
If a deviation is in a locked status, the deviation cannot be deleted.
To Delete
To delete a deviation, the Active Deviation Status must be set to Active Only.
- Select the checkbox by the Deviation 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 deviation, the Active Deviation Status must be set to Deleted Only.
- Select the checkbox by the Deviation record.
- Select Restore Checked in the Choose an Action Press-Go dropdown.
- Select Restore button on the Confirmation Page.
Export to PDF
Deviations can be exported to PDF through the Deviation Manager. Select the desired records and use the Choose an Action tool to generate a zip folder of the selected PDFs. PDF will include eSignature information with date/time/time zone stamp.
- Select the checkbox by the Deviation record(s).
- Select Export to PFD Choose an Action Press-Go dropdown.
- Select download in the green ribbon along the top of your screen to access the zip folder containing your selections.
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