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[Please delete: Please check that this template is the most recent by looking it up on: www.ucl.ac.uk/jro]
JOINT RESEARCH OFFICE (JRO)
Pregnancy
Reporting Form
email sae@ucl.ac.uk
For UCL Sponsored CTIMPs
OR
Fax No 020 3108 2312
Sponsor Protocol No:
(please insert)
Initial Report
Name of CI:
Follow-up Report
Name of Site:
FOR THE ATTENTION OF:
Sponsor Regulatory advisor (SRA), Compliance Oversight advisor (COA) or
Pharmacovigilance Manager
Please complete
Name of Person sending report:
Job title of Person sending report:
Email of Person sending report:
Contact Phone number of Person sending report:
THIS IS AN URGENT REPORT THAT REQUIRES IMMEDIATE ATTENTION
DATE RECEIVED BY SRA, COA or PHARMACOVIGILANCE MANAGER
Pregnancy Reporting Form
v2.0, 11/11/13
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Pregnancy Reporting Form
Study details
Study title
JRO ID No
EudraCT number
1) Patient details (Any information regarding female partners of trial patients should be entered in Other Pregnancy Information section)
Patient initials
Patient study number
Gender
Male
Female
Date of Birth
Type of Report
First
Follow-up
Height
Has CI/PI been
informed?
Yes
No
Was IMP
unblinded?
d
d
m
m
m
y
.
Weight
cm
y
Yes
kg
No
2) Trial treatment
Drug Name
Brand
Most recent cycle number:
Dose
Unit
Frequency
Is this full
dose?
Start date
End date
Route
Ongoing?
d
d
m
m
m
y
y
d
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
d
m
m
m
Date last treatment given before pregnancy confirmation:
Pregnancy Reporting Form v2.0 11/11/13
d
d
m
m
m
y
y
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y
y
3) Concomitant medications?
Drug
Name
Brand
Indication
Y
N
Dose
(Only include drugs given within the last 30 days.
Continue on separate sheet if necessary)
Units
Frequency
d
m
m
m
Y
N
End date
Start date
Route
d
Pregnancy Reporting Form v2.0 11/11/13
Continued on a
separate sheet:
Ongoing?
y
d
y
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
Y
N
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d
m
m
m
y
y
4) Pregnancy Information
Start date of last menses
d
d
m
m
m
y
y
Date pregnancy confirmed
d
d
m
m
m
y
Method of diagnosis
Anticipated date of childbirth
y
d
d
m
m
m
y
y
Mother consented for
pregnancy monitoring
Y
N
Pregnancy Outcome
Not known at this date
Still birth
Induced abortion
Neonatal death
Uneventful (normal/healthy baby)
Spontaneous abortion
Birth defects (provide details in Other Pregnancy Information section
below)
Date of Above Outcome:
d
Date of delivery
d
d
m
m
m
y
y
Gestation
(weeks)
d
m
m
m
Mode of Delivery
y
y
Weight
(kg)
Gender
Male
Female
Antenatal Problems
Postnatal Problems
.
Other Pregnancy Information (concurrent conditions, medical history, complications during birth, birth defects etc)
Past Pregnancy History
Pregnancy Reporting Form v2.0 11/11/13
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Date of delivery
d
d
m
m
m
y
y
Gestation
(weeks)
Mode of Delivery
Signature
PI or other delegated clinicians only
Pregnancy Reporting Form v2.0 11/11/13
Weight
(kg)
Gender
Male
Female
.
Male
Female
.
Male
Female
.
Male
Female
.
Male
Female
.
Male
Female
.
Male
Female
.
Print name
Postnatal Problems
Antenatal Problems
Date of report
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d
d
m
m
m
y
y
Office use only
Date reported to JRO
Date Pregnancy reviewed
d
Is the pregnancy
associated with an
SUSAR?
Form checked by
(signature)
d
*Y
m
m
N
*Link the
two reports
m
y
y
Date reported to MHRA
d
Event No
d
d
m
m
m
y
y
d
m
m
m
y
y
Date event discussed with the Safety
Committee
Date reported to Main REC
d
d
m
m
m
y
d
y
d
m
Print name
Date
d
d
m
m
m
Comments:
Pregnancy Reporting Form v2.0 11/11/13
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y
y
m
m
y
y