SAE

Field

Description

Subject*

The user selects the subject from the dropdown list of subjects that have enrolled in the site. This field is required. This field is read-only when adding or editing a record from the Subject Home page.

Event*

This field is required and the user enters a shortened description (up to 100 characters) of the serious adverse event.

Status*

The user selects from the dropdown list whether the event is ongoing, resolved, unknown, death, or other. This field is required.

SAE Start Date*

The user can enter or select the date when the serious adverse event started. The date must be within the site dates. A check in the box indicates that the date is unknown. This field is required.

SAE End Date*

The user can enter or select the date when the serious adverse event ended. The date must be within the site dates and on or after the SAE Start Date. A check in the box indicates that the date is unknown. If the Status is Ongoing, this field will not be visible. This field is required.

Tracking

Site Notified

The user can enter or select the date when the site was notified of the serious adverse event. If entered, the date must be on or after the SAE Start Date.

Sponsor Notified

The user can enter or select the date when the sponsor was notified of the serious adverse event. If entered, the date must be on or after the SAE Start Date.

IRB/EC Notified

The user can enter or select the date when the IRB or EC was notified of the serious adverse event. If entered, the date must be on or after the SAE Start Date.