Transcript Serious Adverse Event (SAE) Reporting Form

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Serious Adverse Event (SAE) Report
SAE ID
Patient ID
Please indicate whether it is a
SAE or SUSAR being reported:
SAE
EudraCT Number:
Report Type:
Sponsor ID:
Initial
a) Patient data
Age (yrs)
a1)
Patient initials
SUSAR
Follow-up
Source of report: Clinical Trial
Country:
a5) Date
cm a4) Weight
a3) Height
a2) Gender:
kg
d d
of Birth
m m y
y
y
y
b) Serious adverse event information
b1) Date
of onset of first sign/symptom of SAE
d d
m m y
y
y
y
b2) Date
of awareness
d d
m m y
y
y
y
SAE in medical terms (diagnosis, if
possible)
b3)
b4) Case
description of the above SAE
(including signs/symptoms, treatment,
course/outcome and suspected cause
of the SAE)*
c) Seriousness criteria
c1) Patient died
c2) Life threatening
c3) Persistent or significant
disability/incapacity
c4) Involved/prolonged in-patient
hospitalisation
c5) Congenital
anomaly/birth defect
c6) Surgical/medical
intervention to prevent one of the above
(if yes, please briefly outline below:)
d) Outcome at the time of this report
d1) Recovered
Date of recovery
d d
m m y
y
y
y
d2) Recovering
d3) Not
Recovered
with sequelae
d4) Recovered
d5) Fatal
d d
m m y
y
y
Was a post-mortem undertaken?
Yes
No
Was the SAE ongoing at time of
death from other cause?
Yes
No
y
e) Patient’s medical history
e1) Please enter details of any “relevant” prior diseases the patient has suffered that are not being treated
by the study medication.*
Name of conditions. (Continue if necessary on a separate sheet)
a.
Start
d d
m m y
y
y
y
b.
Start
d d
m m y
y
y
y
e2)
End
End
d d
m m y
y
y
y
Ongoing
d d
m m y
y
y
y
Ongoing
Please enter details of any concomitant medication the patient has taken in the last 3 months*
Name of drugs, (if more than 2 drugs please add separately)
a.
Start
d d
m m y
y
y
y
End
d d
m m y
y
y
y
b.
Start
d d
m m y
y
y
y
End
d d
m m y
y
y
y
Page completed by________________________________ Date form completed d d m m y
*Continue on SAE supplemental page CTT21 A if more space is required
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y
y
y
Serious Adverse Event (SAE) Report
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SAE ID
Patient ID
Patient initials
f) IMP information
f1) Initial
trial medication*
Date of initial
dose
Initial trial medication
Trial dose
/units
Route
Frequency
Drug name:
d d
m m y
y
y
y
d d
m m y
y
y
y
d d
m m y
y
y
y
Drug name:
Drug name:
medication at the time of the SAE*
Date treatment
stopped
(if applicable)
Treatment Stopped
Treatment delayed
*% Decrease
Action taken
None
Frequency
Date most
recent dose
Dose / Units
Trial
medication
Route
Most recent trial
medication:
Dose Reduction*
f2) Trial
Drug name:
Drug name:
Drug name:
d d
m m y
y
y
y
d d
m m y
y
y
y
d d
m m y
y
y
y
d d
m m y
y
y
y
d d
m m y
y
y
y
d d
m m y
y
y
y
g) Treatment for the SAE
g1) Was treatment given for the SAE?*
Name of the treatment
Yes (please give details)
Dose
Page completed _________________________________
Units
Route
Frequency
Date form completed d d m m y
*Continue on SAE supplemental page CTT21 A if more space is required
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No (go to Section h)
y
y
y
Serious Adverse Event (SAE) Report
SAE ID
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Patient ID
Patient initials
h) Relevant Diagnostic Tests
h1) Are
there any test / laboratory findings to record?*
Yes (please give details)
Diagnostic test name
Date
i) Causality and Expectedness
i1) Is
the SAE suspected
to be related to the study
treatments?
i2) If
no, what is the most
likely cause?
No (go to Section i)
Test value
d d
m m y
y
y
y
d d
m m y
y
y
y
d d
m m y
y
y
y
d d
m m y
y
y
y
Trial treatment name
Yes
Test units
Expectedness
Expected
Unexpected (= SUSAR)
Expected
Unexpected (= SUSAR)
Expected
Unexpected (= SUSAR)
No (go to i2)
Concomitant medication
(specify medication)
Disease (name)
Other illness (specify)
Other (specify)
THE SAE MUST BE REVIEWED AND THIS SECTION COMPLETED BY THE INVESTGATOR OR AN
AUTHORISED, CLINICALLY QUALIFIED DELEGATE.
Refer to the SPC / IB containing the trial’s Reference Safety Information
Name _________________________________
Address _____________________________
Position _______________________________
_____________________________
Signature______________________________
Tel. No. _____________________________
Email_________________________________
Date
______________________________
j) SUSAR Confirmation by Chief Investigator
All suspected SUSARS must be reviewed by the CHIEF INVESTIGATOR.
Chief Investigator signature to confirm formal review of this event as a SUSAR
Date
Signed
Please note:
•
All suspected SUSARs MUST be sent to the sponsor within 24 hours of awareness for reporting to
the regulator even if the CI is not available.
•
CI review can take place after this time and a SUSAR can be downgraded at a later date.
•
THE SPONSOR WILL REPORT SUSARS TO THE MHRA & REC.
•
E-mail all follow up information for SUSARs to the Sponsor as soon as possible.
Page completed _________________________________
Date form completed d d m m y
y
y
y
*Continue on SAE supplemental page CTT21 A if more space is required
PLEASE E-MAIL SAE REPORTS TO THE SPONSOR <<[email protected]>> within 24
hours of becoming aware of the SAE
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