Fillable Serious Adverse Event (SAE) Report Form (National Institutes of Health)

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Serious Adverse Event (SAE) Report Form (National Institutes of Health)

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The Serious Adverse Event (SAE) Report Form (National Institutes of Health) form is 2 pages long and contains:

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  • 20 check-boxes
  • 26 other fields

Country of origin: US
File type: PDF

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Serious Adverse Event (SAE) Report Form
Serious Adverse Event Report Form 1 of 2 Last Updated 14JUN2019
Protocol Title:
Protocol Number:
Site Number:
Pt_ID:
1. SAE Onset Date:
2. SAE Stop Date:
3. Location of serious adverse event (e.g. at study site or elsewhere):
4. Was this an unexpected adverse event?
Yes
No
5. Brief description of participant with no personal identifiers:
Sex: Female Male Age:
6. Adverse Event Term:
7. Brief description of the nature of the serious adverse event (attach description if more space needed):
8. Category of the serious adverse event:
death – date ____________ congenital anomaly / birth defect
life-threatening
required intervention to prevent
hospitalization - initial or prolonged permanent impairment (Devices Only)
Serious Adverse Event (SAE) Report Form
Serious Adverse Event Report Form 2 of 2 Last Updated 14JUN2019
disability / incapacity
important medical event
9. Intervention type:
Medication (Drug, Biological, Vaccine) or Nutritional Supplement: specify ____________
Device: Specify: ____________
Procedure/Surgery: Specify: ____________
Behavioral/Life Style: Specify: ____________
Radiation: Specify: ____________
Genetic (gene transfer, stem cell, recombinant DNA): Specify: ____________
10. Relationship of event to intervention:
Not Related (clearly not related to the intervention)
Possible (may be related to intervention)
Definite (clearly related to intervention)
11. Was study intervention discontinued due to event?
Yes
No
12. What medications or other steps were taken to treat serious adverse event?
13. List any relevant tests, laboratory data, history, including preexisting medical conditions
14. Type of report:
Initial
Follow-up
Final
Signature of Principal Investigator: Date:
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Serious Adverse Event (SAE) Report Form (National Institutes of Health)

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Completed 19 July 2020

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