Manage safety cases
Ensure the transmission of your subjects' safety cases to Safety by taking select actions, depending on the cases' statuses.
For more information about what each status indicates, see Case statuses.
The transmission of safety cases to Safety is an automated process, requiring no input from site users. However, it may at times be necessary for you to take action on safety cases. Depending on the status of the case you are required to work on, you can perform the following actions:
| Status | Possible actions | Outcome | Notes |
|---|---|---|---|
| Transfer failed | Edit or Resubmit | Submitted | If the case continues to be in a Transfer failed status after resubmission, please contact your Oracle point of contact. |
| Dismissed or Cancelled | Re-open | Submitted | N/A |
| Transfer Failed or Submitted | Cancel | Cancelled | N/A |
| Rejected | Re-open or Cancel | Submitted, Cancelled | Cases with this status are usually accompanied with a rejection reason, which can be found in the Subject History panel. Check the rejection reason to find out whether you need to take further action for cases with this status. |
| Not Submitted | Dismiss or Submit | Dismissed or Submitted, respectively | Once all required questions have been completed, the system automatically submits the case. |
To perform the above actions, you must be assigned to a study role that includes the Cancel a Safety Case and Modify a Safety Case permissions.
- On the Home page, determine where to work. For more information, see Access study modes and pages.
- Along the top, make sure Subjects is selected.
- Filter your view based on several criteria. For more information, see Filter subjects in a study.
- In the table, locate the subject whose safety cases you wish to work on.
- Select the checkbox to the left of the subject.
- On the right, in the Subject History panel, click the menu button for the safety case you wish to work on.
- Select the action to suit the needs of the safety case.
Parent topic: Enter data and dispense kits