View the details of a safety case
Monitor, troubleshoot, and gain a more in-depth understanding of a subject's safety case using the Safety Details & Histories panel.
For you to better understand the status of a safety case, the following items are available:
| Field | Description |
|---|---|
| Subject Number | The Oracle Clinical One Platform subject number. |
| Initial Creation Date | The date when the safety case was first submitted to Oracle Clinical One Digital Gateway. |
| Most Recent Transmission Date | The date when an update was last submitted to Safety. |
| Clinical One Case ID | The ID assigned to the safety case in Oracle Clinical One Platform. |
| Safety Case ID | The ID number assigned to the safety case in Safety. |
| Current Status of the Case | The status of the case as reflected in the Subject History panel. |
| Number of Submissions to Safety | The total count of submissions to Safety, including the initial submission and all subsequent updates. |
| Comments from Safety |
Reflects any comments provided by the Safety team upon receiving the most recent subject data. Comments can be provided for the initial case, but also for follow-up cases. Note: you may need to take action for the safety case based on the information contained in this field. |
- 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, and select View Details.
- Once you have checked the details of the case, you can select Close to return to the Subjects page.
Parent topic: Enter data and dispense kits