Download Pregnancy Reporting Form

JOINT R&D OFFICE
Pregnancy
Reporting Form
Fax No 020 7905 2201
Pregnancy
Initial Report
Follow-up Report
REPORTING FORM
Initial Reporting: For all initial reporting of Pregnancy this form must be completed fully or with as much information as possible (hard copy or
fax) and sent to the Joint R&D Office within 24 hours of the incident occurring or being known.
Follow-up Information: For subsequent follow-up reporting of a pregnancy, a new pregnancy reporting form should be completed with just
administration details and all new or missing information only filled in and forwarded to the Joint R&D Office as soon as possible. All pregnancies
must be followed up until after birth.
Please complete details of any pregnancy from the time of informed consent.
Please use in connection with SOP 05 for investigators.
Please fax this form to the Joint R&D Office GOSH/ICH on 020 7905 2201 within 24 hours of notification of the event.
GOSH/ICH/08/F45/03
Pregnancy Reporting Form
1 of 5
Pregnancy Reporting Form
Please fax this form to the Joint Institute R&D Office on 020 7905 2201 within 24 hours of notification of the event
Study details
Study title
Joint ICH /GOSH R&D Office Project ID
R&D number
CTA/DDX/CTX 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
DD/MM/YY
Gender
Male
Female
Date of Birth
Type of Report
Initial
Follow-up
Height
Has CI been informed?
Yes
No
Was study unblinded?
cm
kg
Weight
Yes
No
Not Applicable
2) Trial treatment
Drug Name
Brand
Most recent cycle number
GOSH/ICH/08/F45/02
Pregnancy Reporting Form
2 of 5
Dose
Unit
Frequency
Is this full
dose?
Route
Start date
Ongoing?
End date
Y
N
DD/MM/YY
Y
N
DD/MM/YY
Y
N
DD/MM/YY
Y
N
DD/MM/YY
Y
N
DD/MM/YY
Y
N
DD/MM/YY
Date last treatment given before
pregnancy confirmation
DD/MM/YY
3) Concomitant Medications?
Drug Name
Brand
Y
(Only include drugs given within last 30 days. Continue on
separate sheet if necessary.
N
Indication
Dose
Units
Frequency
Route
Start date
Continued on separate sheet?
Ongoing?
Y
N
End date
DD/MM/YY
Y
N
DD/MM/YY
DD/MM/YY
Y
N
DD/MM/YY
DD/MM/YY
Y
N
DD/MM/YY
DD/MM/YY
Y
N
DD/MM/YY
4) Pregnancy Information
Start date of last menses
Date pregnancy confirmed
DD/MM/YY
DD/MM/YY
Method of
diagnosis
Anticipated date of childbirth
Mother consented for pregnancy
monitoring
DD/MM/YY
Y
N
Pregnancy Outcome
Not Known at this date
Still birth
Induced abortion
Neonatal death
Uneventful (normal/healthy baby)
Birth defects (provide details in Other Pregnancy Information section below)
Date of above outcome
Date of delivery
DD/MM/YY
GOSH/ICH/08/F45/02
Pregnancy Reporting Form
3 of 5
Spontaneous abortion
DD/MM/YY
Gestation
(weeks)
Mode of delivery
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
Date of Delivery
Gestation
(weeks)
Mode of Delivery
Gender
DD/MM/YY
Male
Female
DD/MM/YY
Male
Female
DD/MM/YY
Male
Female
Signature
PI or other participating
clinicians only
GOSH/ICH/08/F45/02
Pregnancy Reporting Form
4 of 5
Print name
Weight
(Kg)
Antenatal Problems
Date of report
Postnatal
Problems
DD/MM/YY
For Sponsor / R&D Office use only
Date event reported
DD/MM/YY
Date event reviewed
DD/MM/YY
Assessment of expectedness: (Was the event listed in the study protocol, SmPC or Investigator’s Brochure?)
Event considered as
SAE
SAR
SUSAR
Event No
Expected
Unexpected
If event is a SUSAR, Submission deadline (expedited
reporting):
DD/MM/YY
Date event was recorded on data
base
DD/MM/YY
Date report was acknowledged to reporter by Sponsor
DD/MM/YY
If SUSAR, date reported to MHRA
DD/MM/YY
If SUSAR, date reported to Main REC/GTAC
DD/MM/YY
Reported to all other PIs
Yes
No
N/A
Comments:
Signature
Print name
Date of review
DD/MM/YY
GOSH/ICH/08/F45/02
Pregnancy Reporting Form
5 of 5