Princess Margaret Hospital for Children
Human Research Ethics Committee
INITIAL SERIOUS ADVERSE EVENT REPORT
For Serious Adverse Events occurring at CAHS or other areas for which Ethics Committee has given approval
to conduct the trial the investigator should notify the Ethics Committee within 72 hours of the event.
Title of Protocol:
SAERreport No.
Protocol No
Date of Protocol:
Date Informed Consent Obtained
CAHS HREC Ref No
Study Drug/s
Principal Investigator/s:
Date patient
commenced on study:
Date of Adverse Event:
Date of Report:
Gender: F
Was Informed Consent Obtained:
Yes
Enrolment No:
M
DOB:
No
Description of Event:
(Double click left mouse on box to insert X - tick all that apply)
Likely cause of Event
Study drug/treatment
Relationship to study
Directly Related
Standard treatment
Possibly Related
Progressive disease
Not Related
Concurrent medication
Concurrent disorder
Other
If other, please specify:
SAE Initial Form
Version 2, 6 Feb 2013
1 of 2
Outcome
fatal
life threatening
hospitalisation required/prolonged
permanent or significant disability/incapacity
Other
If other, please specify:
Did this adverse event occur at CAHS ?
Yes
No
Do you believe this was directly related to the trial?
Yes
No
Was this adverse event anticipated in the original study protocol?
Yes
No
Was it described in the Patient Information Sheet?
Yes
No
If not, where did it occur?
Do you believe this report raises any additional safety concerns for the patients enrolled in your study?
Will there be changes as a result of this event to the Patient Information Sheet?
Yes
No
Yes
No
Yes
No
(If yes, please attach new P.I.S.).
Will you continue to recruit/study patients on this trial?
Adverse Event noted in Medical Record
Yes
No
N/A
Adverse Event notified to Clinical Care Unit
Yes
No
N/A
Adverse Event notified to Office of Quality, Safety and Performance
Yes
No
N/A
Clinical Incident ( AIMS) Form Submitted
Yes
No
N/A
Additional Information:
Signature of Principal Investigator:
Date
NB: Completed,Signed and Dated Form to be forwarded electronically to [email protected] for
notice of PMH Ethics Committee
SAE Initial Form
Version 2, 6 Feb 2013
2 of 2