1. Study info
2. SAE report
METC or ABR Number
Study Title (short)
EudraCT Number (if applicable)
Year of birth of subject
An initial report must be sent to xxx xxx xxx within 24 hours after (investigator becomes aware of) the serious adverse event.
Date of report
Type of report
Name Principal Investigator (local)
Institute local Principal Investigator
Office phone local Principal Investigator
Fax local Principal Investigator
Email local Principal Investigator
Date of onset Serious Adverse Event
Brief description of Subject:
Gender of subject
Category of the serious adverse event
Relationship of serious adverse event to the investigational medicinal product, the investigational medical device or the investigational treatment:
What is being investigated?
Relationship of SAE to the investigational medicinal product/treatment of device
Was the event/reaction expected or unexpected?
Expected: the event is known, i.e. reported in earlier research as possibly related. Unexpected: the event is unknown, i.e. not reported in earlier research.
Action taken with investigational product or the experimental treatment
What is the outcome of the SAE
Date event resolved
Date patient died
Did the person who completed the SAE report sign the paper SEA form?
Did the Principal Investigator sign the paper SAE form?
3: Hospitalization- initial or prolonged
5: Congenital anomaly/birth defect
6: Required intervention to prevent all of the aformentioned situations
1: Medicinal Product
2: Investigational Treatment
3: Medical Device
2: Discontinued temporarily
4: Dose temporarily reduced
5: Dose reduced
2: Recovered with sequelae
4: Resulted in death