What Is SAE Tracking
Site SAE Tracking records SAE (serious adverse event) information arising at a study site during a study, for CRAs and the monitoring team to track. Entry point: Site Monitoring → Site SAE Tracking; you can also register from the Site SAE Tracking section of a Monitoring Event detail page.
Registering an SAE
Create a record; Name auto-numbers (SAE-{######}):
| Field | Notes |
|---|---|
| Study / Study Country / Study Site | Owning levels (required, cascading); auto-filled when created from a monitoring event |
| Subject | The subject (required, filtered by site) |
| Monitoring Event | Optionally link the event where the SAE was identified |
| SAE Name | SAE name (e.g. the event description) |
| SAE Start Date | SAE start date (required) |
| SAE End Date | SAE end date |
| SAE Severity | Mild / Moderate / Severe |
| Outcome | Outcome (required) |
| Related? / Expected? | Relationship to the study drug / whether expected |
| SAE Report Final | Whether the SAE report is final |
Note
This page is a tracking ledger: register basic SAE information and outcomes; formal pharmacovigilance reporting and submission still follow your institution's SOP in the designated system.
States & Maintenance
The lifecycle has only Active → Inactive (Status is lifecycle-driven, not hand-editable), with no automation. Records are maintained manually by the CRA and study team; follow up at monitoring visits and switch the record to Inactive once closed out.
Troubleshooting
| Symptom | Suggestion |
|---|---|
| Can't pick a Subject | The subject must belong to the chosen study site; pick the right Study Site first |
| Fields are empty when creating from a monitoring event | Create from the Site SAE Tracking section on the event detail so Study/Site fill automatically |
| Status can't be edited | Status is lifecycle-driven; use lifecycle actions to switch Active / Inactive |
Required Permissions & Roles
| Type | Permission | Controls |
|---|---|---|
| Object | Site SAE Tracking: Create, Read, Edit | Registering and maintaining SAE tracking records |
The CRA is the primary user; CTMS Study Manager and Central Monitor can also create and edit; delete and workflow execution are limited to CTMS Business/System Administrators.