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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  • 11 check-boxes
  • 32 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 Version 1.1
1. SAE Onset Date: _______________ (dd/mmm/yyyy)
2. SAE Stop Date: _________________ (dd/mmm/yyyy)
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(s):
___________________________________________________________________________________
___________________________________________________________________________________
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 _____________(dd/mmm/yyyy) congenital anomaly / birth defect
life-threatening required intervention to prevent
hospitalization - initial or prolonged permanent impairment
disability / incapacity other:______________________
Protocol Title:
Protocol Number: ______________________
Site Number: ______________________
Pt_ID: ______________________
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Serious Adverse Event (SAE) Report Form
Serious Adverse Event Report Form 2 of 2 Version 1.1
9. Intervention type:
Medication or Nutritional Supplement: specify___________
Device: Specify: ________________________
Surgery: Specify: ________________________
Behavioral/Life Style: Specify: _____________________
10. Relationship of event to intervention:
Unrelated (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: ______________ (dd/mmm/yyyy)
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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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