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Adverse Event Report Form

Download Adverse Event Report Form.doc




Patient Details *
Initials
Hospital No.
Date of Birth or age
Sex
female male
Weight (kgs)
Height (cms)
Reporter Information *
Reporters Name
Reporters Address
City
Post code
Country
Phone Number, E-mail
Reporters qualification Physician Pharmacist Other Health Professional*
Reported to regulatory authority?
Yes No
Suspect Drug(s) *
Drug name
Form
Manufacturer
Lot No.
Indication
Dose, units (ml, mg)
Frequency (x1/x2/x3/x4...)
Route (p/o, i/m, i/v...)
Start Date
Stop Date
Action Taken with suspect drug
Adverse Event Description *
Diagnosis of Adverse Event(s). If diagnosis not known, give symptom(s)
Start date
Stop date
Time
Intensity Mild Moderate Severe
Outcome
Did AE improve after stopping or reducing drug& Yes No Not available
Did AE reappear after reintroduction? Yes No Not available
Relevant Medical History/Concurrent Diseases (treatment, test results)
Do you consider that there is reasonable possibility that the event may have been caused by the Suspect Drug(s)?
Yes No
Reason
Seriousness:
Is the Adverse Event serious?
Yes No
Is the Adverse Event serious?
If "Death", specify the Cause
Date of Death
Post Mortem/ autopsy performed?
Yes No
Relevant Medical History, Concurrent Diseases
Please include drug reactions, allergies, environmental factors,- and (or) drug & alcohol abuse
Other drug(s)
Concomitant Drug(s) (Exclude drugs used to treat the event)
Form
Manufacturer
Lot. No.
Indication
Daily dosage, units (x1/x2/x3/x4)
Frequency (x1/x2/x3/x4...)
Route
Start Date
Stop Date
 
* — mandatory fields