FOR SPONSOR USE ONLY: /

Initial Pregnancy Report

Instructions on use of form (Delete this box when submitting form)
When to use:
Used to report details of any pregnancy from the time of informed consent experienced by trial participant or by partner of trial participant.
Consent:
The mother must give her consent in order for the pregnancy to be followed up.
Initial Reporting: For all initial reporting of Pregnancy this form must be completed fully or with as much information as possible and send to the NUH R&I within 24 hours of the incident occurring or being known.
Study Title:
R&I Reference Number:
EudraCT Number:
  1. REPORT DETAILS

Centre/Site Name & Address:
Centre/Site ID:
Date of Report / (dd/mm/yyyy)
Report Type: / Notification of pregnancy in female participant
Notification of pregnancy in partner of male participant
Patient Information: / ID No:______ / DOB:(dd/mm/yyyy):______
IMP unblinded? / Yes No
  1. MATERNAL INFORMATION

Mother has consented for Pregnancy monitoring? Yes No
Date of last menstrual period: (dd/mm/yyyy):______/ Expected date of delivery(dd/mm/yyyy): ______
Method of contraception:______/ Contraception used as instructed? Yes No Uncertain
  1. MEDICAL HISTORY
(include information on familial disorders, known risk factors or conditions that may affect the outcome of the pregnancy. If none, mark as N/A)
4. PREVIOUS OBSTETRIC HISTORY (provide details on all previous pregnancies, including termination or stillbirth)
Gestation week / Outcome including any abnormalities
1
2
3
4
5. DRUG INFORMATION (list all therapies taken prior to and during pregnancy)
Name of drug / Daily dose / Route / Date started
(dd/mm/yyyy) / Date stopped
(dd/mm /yyyy) / Indication / Treatment
start
(week of pregnancy) / Treatment
stop
(week of pregnancy)
Insert additional rows if necessary
Insert additional rows if necessary
6. PRENATAL INFORMATION
Have any specific tests, e.g. amniocentesis, ultrasound, maternal serum AFP, been performed during the pregnancy so far?
No Yes Not known
If yes, please specify test date and results:
7. ADDITIONAL INFORMATION
8. INFORMATION SOURCE FOR INITIAL REPORT
Name, address and telephone number and email address of person completing report:
PI name:
PI signature: / Date:
dd/mm/yy
Submit the report to Nottingham University Hospitals NHS Trust Research and Innovation department
by one of the following methods:
  1. Email ()
  2. Fax (0115 8493295)
  3. Hand delivered (R&I, NHSP, C Floor, South Block, QMC)
For queries please telephone 0115 9709049
FOR SPONSOR USE ONLY
Report Received by: / Reference Number:
Name (PRINT and Sign) / Date(dd/mm/yyyy) / Time
Report Checked and Tracked by:
Name (PRINT and Sign) / Date(dd/mm/yyyy) / Time
SAE Reporting
Reported as SAE? / Yes
No / Date reported to Sponsor:
(dd/mm/yyyy) / SAE Reference Number:
Reported as SUSAR? / Yes
No / Date reported to Main REC:
(dd/mm/yyyy)
Date reported to MHRA:
(dd/mm/yyyy) / SUSAR Reference Number:
Comments:

TAFR01905_Pregnancy Reporting Form (CTIMP)_Version 1 Page 1 of 7

Effective Date 22/Jan/2016