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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