1.1
METC or ABR Number
1.2
Study Title (short)
1.3
EudraCT Number (if applicable)
1.4
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.
2.1
Date of report
2.2
Type of report
2.3
Name Principal Investigator (local)
2.4
Institute local Principal Investigator
2.5
Office phone local Principal Investigator
2.6
Fax local Principal Investigator
2.7
Email local Principal Investigator
2.8
Date of onset Serious Adverse Event
Brief description of Subject:
2.9
Gender of subject
2.10
Diagnosis subject
2.11
Event/Reaction
2.12
Describe event
2.13
Category of the serious adverse event
Relationship of serious adverse event to the investigational medicinal product, the investigational medical device or the investigational treatment:
2.14
What is being investigated?
2.15
Relationship of SAE to the investigational medicinal product/treatment of device
2.16
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.
2.17
Action taken with investigational product or the experimental treatment
2.18
What is the outcome of the SAE
2.19
Date event resolved
2.20
Date patient died
2.21
Remarks
2.22
Did the person who completed the SAE report sign the paper SEA form?
2.23
Did the Principal Investigator sign the paper SAE form?
Report type
1: Initial
2: Follow-up
3: Final
Gender
1: Male
2: Female
Category
1: Death
2: Life-threatening
3: Hospitalization- initial or prolonged
4: Disability/incapacity
5: Congenital anomaly/birth defect
6: Required intervention to prevent all of the aformentioned situations
Under investigation
1: Medicinal Product
2: Investigational Treatment
3: Medical Device
Relationship
1: Unrelated
2: Possible
3: Definite
Event expected
1: Expected
2: Unexpected
Action taken_SAE
1: None
2: Discontinued temporarily
3: Discontinued
4: Dose temporarily reduced
5: Dose reduced
Outcome SAE
1: Recovered
2: Recovered with sequelae
3: Continuing
4: Resulted in death
5: Unknown
Yes/No
1: Yes
2: No