JOINT RESEARCH MANAGEMENT OFFICE
PREGNANCY REPORTING FORM
(BH/QM sponsored trial)
Once you have become aware of a Participant or spouse pregnancy, please complete, scan &
email/fax this signed form to the GCP Team: 020 7882 7276 (or to the trial co-ordinator’s fax
number if multi site project) WITHIN 24 hours of learning of the pregnancy. Please ensure you
reviewed and acknowledgment of recipe from the JRMO, print it and file it in your TMF along with
the original.
Report type:
Initial

Follow up

If the project is multi-site, the section below should be completed by the Main site Trial
coordinator prior to sending the template to the sites
Full title of the study:
Name of sponsor:
Sponsor R&D Number:
MREC Number:
Chief Investigator:
BH

EudraCT Number:
QMUL

Is this a double blind study?
Name:
Email address:
Yes
Name of ALL IMPs and/or
medical devices
If Yes are the code break procedures in place with pharmacy? Yes
No
IMP 1:
IMP 3:
IMP 2:
IMP 4:
This section should be completed by the SITE:
Subject identification code:
Subject or partner :
If partner date of consent ( for pregnancy and
outcome follow up:
DOB: (Day/Month/Year)
( ___
/___/____)
Patient’s Age:
Principal Investigator:
Name:
Email address:
Trial Co-ordinator local site:
Name of reporting host
institution:
Date of site becoming aware of
the event
Phone No:
No
Patient/initials (first,
last):
_________
Sex:
M 
Name:
Email address:
Trust/ Institution name:
Site number:
F 
Phone No:
Phone No:
___/___/____
1. MATERNAL INFORMATION
Date of Birth
Date of last menstrual period
Expected Date of Delivery
Method of contraception:
Contraception used as
instructed?
Yes
No
Uncertain
2. MEDICAL HISTORY (include information on familial disorders, known risk factors or conditions that
may affect the outcome of the pregnancy.)
3. PREVIOUS OBSTETRIC HISTORY (provide details on all previous pregnancies, including
termination or stillbirth
Pregnancy reporting and outcome form 1.2
Page 1 of 4
Gestation week
Outcome including any abnormalities
1.
2.
3.
4.
4. DRUG INFORMATION (list all therapies taken prior to and during pregnancy)
Name of
Daily
Route
Date Started
Indi Date
Treatment
drug
Dose
cati Stopped Start
on
(week of
pregnancy
Treatment
Stop
(week of
pregnancy)
5. PRENATAL INFORMATION
Have any specific tests, e.g.
amniocentesis, ultrasound,
maternal serum AFP, been
performed during the pregnancy
so far
Yes
No
Not
known
If yes, please specify:
Test:
Test Date:
Result:
6. PREGNANCY OUTCOME
Please ensure to collect and report this information to the
sponsor within one week of outcome OR within 24 hours if an
adverse outcome is learnt
(b) Delivery Yes No
(a) Miscarriage Yes No
If Yes:
If Yes
Termination of
pregnancy
Planned
Spontaneous
Normal
Forceps/Ventouse
Caesarean
If yes please specify
elective or emergency
Maternal complications or problems related to birth:
Please specify the reason and any
abnormalities (if known):
Date of miscarriage:
Date of Delivery:
Gestational age at miscarriage:
7. MATERNAL PREGNANCY ASSOCIATED EVENTS
If the mother experiences an SAE during the pregnancy, please indicate here and complete an SAE
form and submit to JRMO immediately.
8. CHILD OUTCOME
Congenital
Yes/Nol
If any congenital abnormalities, please specify
Stillbirth
If yes specify date
Admission to neonatal intensive
care unit
If YES reason for admission to
the unit
Neonatal death
Sex:
Head circumference:
cm
Weight¨
kg
Yes/No
Yes/No
Apgar
Scores:
Height:
cm
Pregnancy reporting and outcome form 1.2
1 min
5 mins
10 mins
Page 2 of 4
9. CHILD OUTCOME FOLLOW UP
This form should adapted per study to include child follow-up in applicable trials (see protocol)
10. ASSESSMENT OF SERIOUSNESS (OF PREGNANCY OUTCOME)
Life-threatening
Mother died
Stillbirth/neonate died
Date of death
Date of death
Involved prolonged inpatient
hospitalisation
Results in persistent or significant
disability/incapacity
Other seriousness criteria:
Congenital
Other
anomaly/birth
significant
defect
medical
Events:
11. ASSESSMENT OF CAUSALITY(OF PREGNANCY OUTCOME)
Please indicate the relationship between pregnancy outcome
Is the SAE likely to be a
IMP X likely or possibly Related

Unrelated

reaction to one of the IMPs
with in the trial?
12. ADDITIONAL INFORMATION:
Person completing the form
If not the PI specify Name:
Phone No:
Email address:
Signature:
Date:
Investigator’s Name (PLEASE Print) :
Investigator’s Signature
Date:
For Multi-site trials only
Date form RECEIVED by CI’s team
from external site: ( ___ /___/____)
Date reviewed by sponsor
obstetrician ( ___ /___/____)
For R&D Office use only
Date form RECEIVED by R&D team:
( ___ /___/____)
For SUSAR only:
CI Reviewed by:
Date:
Reviewed by:
Date:
Reviewed by:
Date reviewed:
Date reported to the MHRA:
Pregnancy reporting and outcome form 1.2
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Pregnancy reporting and outcome form 1.2
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