Medical and Health Research Ethics Committee SOP 6.1-019.

2012-02
(MHREC) Effective date:
Faculty of Medicine Universitas Gadjah Mada 1 October 2012
Page 1 of 2

6.1. Review of Serious Adverse Event (SAE)

Reports

ANNEX 1
AF 6.1.01-019.2012-02
page 1 of 2
SERIOUS ADVERSE EVENT REPORT

Principal Investigator:…………………………………….. Application No:

Study Protocol No.:
Title:……………………………………………………….

Name of the study Report Date :…………

medicine/device………………………..…………………  initial  follow-up
Onset date:……………
Sponsor:………………………………………………… Date of first use:
………………………..

Subject’s initial/number: Age:  Male  Female

Subject’s history: Laboratory findings:

SAE: Treatment:
Outcome:  resolved  on-going

Seriousness: Relation to  Drug  Device  study

 Death  Not related
 Life Threatening  Possibly
 Hospitalization – initial  prolong  Probably
 Disability / Incapacity  Definitely related
 Congenital Anomaly  Unknown
 Other…………………………………

Reporter : Sign date

 Medical and Health Research Ethics Committee SOP 6.1-019.2012-02
(MHREC) Effective date:
Faculty of Medicine Universitas Gadjah Mada 1 October 2012
Page 2 of 2

6.1. Review of Serious Adverse Event (SAE)

Reports

ANNEX 1
AF 6.1.01-019.2012-02
page 2 of 2

Changes to the protocol recommended?  No  Yes , attach proposal

Changes to the informed consent form  No  Yes , attach proposal
recommended?

Reviewed by:………………………………………………… Date:……………

Comment:……………………………………………………. Action:……………
………………………………………………………………… ……………………