Summary
This article covers how to access and configure study deviations.
Table of Contents
- Access Study Deviation
- Study Deviation Table
- Actions
- Choose an Action Press Go
- Configuring Dashboard Notifications
Deviations for the study are managed through the Deviation form, one of many Configurable Forms. Deviation Approval transitions are used to progress deviations through the approval workflow, as configured by the study team.
Users do not need full access to a study to access Deviations. If a user has restricted access at the country or site level, they will be able to view Deviations at their access level.
The Study Form contains a Select Study Workflows button, Within this tool, the study staff can select which deviation approval workflow should be used on the current study.
Access Study Deviation
For information on study deviations for existing studies, click Study Deviations under the Study Menu.
Study Deviation Table
The Study Deviation table will list all study deviations that have been added. The Study Deviations table includes:
| Name | Value | Action |
|---|---|---|
| Date of Deviation | Date entered on Deviation form for Date of Deviation. | (none) |
| Deviation Category | Category entered on Deviation form for Deviation Category. | (none) |
| Editor Options | Read, Edit, Delete | Tools for those with proper permissions |
| Transition Status | Current deviation workflow status and transition icon | Displays Deviation Transition Dialog. |
| Description of the Deviation | Description entered on the Deviation form. | (none) |
| Audits | Audit Trail icon | Displays the deviation transition audit trail. |
| Action Taken | Displays the action taken entered on the Deviation form. | (none) |
| Active Deviation | Active or Deleted | (none) |
| Study Site | Displays the affected site(s). | (none) |
| Created By | Name of creator. | (none) |
| Submitted | Submitted Date as determined by the approval workflow. | (none) |
| Finalized | Finalized Date as determined by the approval workflow. | (none) |
Note: The edit and delete icons will become inactive when the deviation has been transitioned to a status that locks the deviation.Actions
Add Deviation
To add a deviation to this study, complete the Deviation Form.
Exports
By clicking the options Excel or CSV, the system will provide an export of the data contained in the manager.
Choose an Action Press Go
Delete Checked
To delete a deviation:
- Select deviation(s)
- Select Delete Checked from Choose an Action Press Go menu
- Click Go
To Export to PDF
- Select Deviation(s)
- Select Export to PDF
- Click Go
*Exporting to PDF includes eSignature information with date/time/time zone stamp.
Configuring Dashboard Notifications
The Save Search functionality found in every manager’s filter allows you to save the current search criteria (filters and sort selections) and name the search. Taking these steps creates a prepared search in the Checklist Widget found on the Dashboard. From the Checklist Widget users can view how many records appear in the search results as well as click the name of the search to link directly to the search results.
Need more help?
Please visit the Fountayn Contact Information page.