Transcript Slide 1

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Sponsor SAE Report Form
To:
Quality Assurance
From (name): ……………………….. ………
Research & Development
34 Hyde Terrace
Location:
………………………………..
Address:
LS2 9LN
……………………………..
Date:
Tel:
Fax To:
Fax:
+44(0)113 392 6397
Please Complete All sections
Leeds Sponsor ID: _______/_______
Trial Short Name:…………………………
Patient Trial ID:______________
SAE ID: __ __ __ __ / __ __ __ __ / __ __ __ __
(R&D number /
Patient ID
/ SAE number)
Number of Pages (including SAE Form Supplemental page CTT21 A if required) ________
This report is:
Initial
Follow Up
This SAE is a SUSAR:
Yes
No
This SAE requires un-blinding?
Yes
No
FOR SPONSOR QUALITY ASSURANCE OFFICE USE ONLY……………………
Please note: this fax sheet will be returned to the sender to confirm receipt and to
notify the anticipated response time from the Quality Assurance department:No queries identified – please send follow up report/any additional
information as soon as possible.
Queries identified - Quality Assurance will respond to this SAE within
……………. working days with any required action.
Signed:
Dated:
SAE Report CTT21 V5.0 131021
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Serious Adverse Event (SAE) Report
Centre Number
Patient initials
Trial Number
Patient ID
EudraCT Number:
Report Type:
Initial
Follow-up
a) Patient data
a2) Gender:
a1) Age
Source of report: Clinical Trial
Sponsor ID:
Country
a3)
Male
Height (cm):
a4) Weight
(kg):
A5)Date
of Birth d d
m m y
y
y
y
Female
(yrs)
b) Serious adverse event information
b1)
Date of onset of first sign/symptom
of SAE
b3)
d d
m m y
y
y
b2)
y
Date of awareness
d d
m m y
y
y
y
SAE in medical terms (diagnosis, if possible)
b4)
Case description of the above SAE
(including signs/symptoms, treatment,
course/outcome and suspected cause of the
SAE) (continue on SAE supplemental page
CTT21 A section b4i if more space is
required)
c) Seriousness criteria
c1) Patient died
c2) Life threatening
c3) Persistent
c4) Involved/prolonged
c5) Congenital
in-patient hospitalisation
anomaly/birth defect
c6) Surgical/medical
or significant disability/incapacity
intervention to prevent one of the above
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
y
Was a post-mortem undertaken?
Yes
No
Was the SAE ongoing at time of
death from other cause?
Yes
No
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. (continue on SAE supplemental page CTT21 A section e4i if more space is required)
Name of conditions, Repeat if necessary on a separate sheet.
a.
start
d d
m m y
y
y
y
end
d d
m m y
y
y
y
ongoing
b.
start
d d
m m y
y
y
y
end
d d
m m y
y
y
y
ongoing
e2) Please
enter details of any non-study medication that the patient has taken outside of the last 3 months. Any medication taken
within the last 3 months should be entered as Concomitant (continue on SAE supplemental page CTT21 A section e2i if more
space is required)
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
y
y
y
PLEASE FAX SAE REPORTS TO THE SPONSOR <<0113 392 6397>> within 24 hours of becoming aware of the SAE. THE
SPONSOR WILL REPRT ALL SUSARS TO THE MHRA. Fax all follow up information for SUSARs to the Sponsor as soon as
possible.
SAE Report CTT21 V5.0 131021
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Serious Adverse Event (SAE) Report
Centre Number
Patient initials
Trial Number
Patient ID
f) Trial Medicinal Information
f1)
First trial medicinal information(continue on SAE supplemental page CTT21 A section f1i if more space is required)
First ever trial medication
Start date 1st ever
trial dose
1st ever
trial dose
Drug name:
d d
m m y
y
y
y
Drug name:
d d
m m y
y
y
y
Drug name:
d d
m m y
y
y
y
1st ever
trial units
1st ever
trial route
1st ever trial
frequency
Trial medicinal information at the time of the SAE (continue on SAE supplemental page CTT21 A section f2i if more space
is required)
m m y
y
y
Treatment delayed
*% Decrease
Dose Reduction*
None
Frequency
d d
Action taken
Route
Drug name:
Most recent trial
medication:
Units
Date most recent
dose
Dose
Trial medication
Treatment Stopped
f2)
If treatment
stopped: Stop date
y
Drug name:
d d
m m y
y
y
y
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
Sponsor note: Section f to be updated with all trial drug names at the beginning of the trial.
g) Treatment for the SAE
g1)
Was treatment given for the SAE?
Name of the treatment
Yes (please give details)
Dose
No (go to Section h)
Units
Route
Frequency
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
Tick if using
Continue on SAE supplemental page CTT21 A section g1i if more space is required
Page completed by_________________________________________
Date form completed
d d
m m y
y
y
PLEASE FAX SAE REPORTS TO THE SPONSOR <<0113 392 6397>> within 24 hours of becoming aware of the SAE. THE
SPONSOR WILL REPRT ALL SUSARS TO THE MHRA. Fax follow up information for SUSARs to the Sponsor as soon as
possible.
SAE Report CTT21 V5.0 131021
y
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Serious Adverse Event (SAE) Report
Centre Number
Patient initials
Trial Number
Patient ID
h) Relevant Diagnostic Tests
h1)
Are there any test / laboratory findings to record?
Diagnostic test name
Yes (please give details)
Date
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
Test units
Continue on SAE supplemental page CTT21 A section h1i if more space is required
Trial treatment name
i) Causality and Expectedness
i1)
Is the SAE suspected to be
related to the study
treatments?
Yes
Tick if using
Expectedness
Expected
Unexpected (= SUSAR)
Expected
Unexpected (= SUSAR)
Expected
Unexpected (= SUSAR)
No (go to i2)
i2)
If no, what is the most
likely cause?
Concomitant medications (Report on the CONCOMITANT MEDICATIONS SUPPLEMENTAL
PAGE)
Tick if using
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 current approved SPC / IB appropriate to the trial
Name _________________________________
Address
______________________________
Position _______________________________
Signature______________________________
i3)
______________________________
Tel. No.
______________________________
Date
______________________________
All suspected SUSARS must be reviewed by the CHIEF INVESTIGATOR.
Chief Investigator signature to confirm formal review of this event as a SUSAR
Sign
Date
All suspected SUSARs should 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.
Sponsor note: Section i to be updated with disease name and all trial drug names at the beginning of the trial.
Page completed by_________________________________________
Date form completed
d d
m m y
y
y
PLEASE FAX SAE REPORTS TO THE SPONSOR <<0113 392 6397>> within 24 hours of becoming aware of the SAE. THE
SPONSOR WILL REPRT ALL SUSARS TO THE MHRA. Fax follow up information for SUSARs to the Sponsor as soon as
possible.
SAE Report CTT21 V5.0 131021
y