SEVERE ADVERSE EVENT (SAE) REPORT FORM

STUDY TITLE
PROTOCOL NO.	SITE NO.
SITE
PATIENT ID	DATE OF REPORT	dd-mm-yyyy

1.	SAE Date of Onset:	dd-mm-yyyy
2.	SAE Date Stopped:	dd-mm-yyyy
3.	Location of SAE:
4.	Was this an unexpected adverse event?	☐ Yes ☐ No
5.	Brief description of participants (do not include personal identifiers):	Gender	☐ Male ☐ Female ☐ Other, identify
Age
Diagnosis for study participation
6.	Brief description of the nature of the SAE: attach description, if applicable
7.	Category of SAE:	☐ Date of Death:	dd-mm-yyyy
☐ Life threatening	☐ Congenital anomaly, birth defects
☐ Life threatening	☐ Required intervention to prevent impairment (permanent)
☐ Hospitalization	☐ Disability
☐ Other:
8.	Describe intervention type:
9.	Relationship of event to intervention:	☐ Unrelated	☐ Possible	☐ Definite
10.	Was the study intervention discontinued due to the event?	☐ Yes ☐ No
11.	What steps were taken to treat the SAE?
12.	List relevant tests, lab data, history, and pre-existing medical conditions:
13.	Report type:	☐ Initial	☐ Follow-up	☐ Final

Print Name of Principal Investigator
Signature of Principal Investigator	Date

DISCLAIMER Any articles, templates, or information provided by Smartsheet on the website are for reference only. While we strive to keep the information up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability, or availability with respect to the website or the information, articles, templates, or related graphics contained on the website. Any reliance you place on such information is therefore strictly at your own risk. This template is provided as a sample only. This template is in no way meant as legal or compliance advice. Users of the template must determine what information is necessary and needed to accomplish their objectives.