/ Serious Adverse Event Form
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Report No:
Eudract No/Study ID: Subject ID/ Randomisation No:
Date SAE Notified to Investigator:Date of Report:
Trial Name:
Initial Report Follow Up Report Country where event occurred: Centre ID:
Is this a possible SUSAR? Yes No
Subject Details
Initials Date of Birth Gender Male Female
Height (cm) Weight (kg)
Serious Adverse Event
Onset Date:
Diagnosis:
Expectedness: Expected Unexpected
Relationship to study drug: None Possible Probable Definite
Severity Mild Moderate Severe
Outcome: Recovered Recovered with Sequelae Recovering Not Recovered Unknown Fatal

Date of Recovery:
Seriousness Criteria (Check all that apply):
Resulted in death Life-threatening Hospitalisation/Prolongation of hospitalisation
Persistent/Significant Congenital anomaly/ Other important medical event
Disability/incapacity Birth Defect
If resulted in death:
Date of Death / Cause of Death: / Cause of Death determined by Autopsy:
Yes No
Action Taken: Drug withdrawn Dose Reduced Dose Increased
Dose not changed Unknown Not applicable
Event Narrative Provide any information regarding the circumstances, sequence, diagnosis and the treatment of the event(s) not otherwise on this form.

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/ Serious Adverse Event Form
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Report No:
Eudract No/Study ID: Subject ID/ Randomisation No:
Date SAE Notified to Investigator:Date of Report:

Protocol Treatment(s):

Did the subject have to be unblinded? Yes No If yes, was subject on placebo? Yes No

Study Drug / Dose / Frequency / Start Date / End Date / Route / Batch
Tick if still ongoing
Relevant Tests: List only relevant confirmatory test result(s), for example from blood tests, diagnostic imaging
Test / Date / Result / Normal Range
Low-High / Comments
Medical History:
Provide relevant medical history below or include a copy of the Medical History case report form page.
Include other illnesses present at the time of the event, previous study emergent adverse events, and pre-existing medical condition. If additional space is necessary, use further copies of this page
Condition / Start Date / End Date / Medication Required
Ongoing / Yes No
Concomitant Medications:
Drug / Start / End / Tick if Still ongoing / Dose / Frequency / Route / Indications / Causality

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/ Serious Adverse Event Form
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Report No:
Eudract No/Study ID: Subject ID/ Randomisation No:
Date SAE Notified to Investigator:Date of Report:
Rechallenge Information
  1. Did the reaction abate after stopping suspect drug? Yes No N/A
  1. Did the reaction reappear after re-introduction of Yes No N/A
suspect drug?
THIS REPORT MUST BE SIGNED AND DATED BY THE INVESTIGATOR
Name of Investigator
Signature / Date
  • Please send a signed and dated form within 24 hours to
  • A copy should also be added to your study site file
  • Receipt will be acknowledged by email

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