serious adverse event (SAE) reporting form

Is this an original or revised submission?

Original

Revised

Name of the Person Entering Data into this CRF

First Name

Last Name

Date of Study Procedure

MM

DD

YYYY

SAE Onset Date

MM

DD

YYYY

Date Site First Became Aware of the SAE

MM

DD

YYYY

Reason for SAE Designation

Death

Life-Threatening Event

Hospitalization or Prolonged Hospitalization

Disabling and/or Incapacitating

Important Medical Event

Relationship to Study Treatment

Not Related

Remote

Possible

Definite

Outcome

Recovered

Recovered with Sequelae

Ongoing

Death

Expectedness

Expected

Unexpected

Treatment

None

Treatment/Medication

Hospitalization

Other

SAE End Date

MM

DD

YYYY

Attestation *

I approve the data entered into this CRF and attest to its accuracy.

Date of Completion

MM

DD

YYYY