ࡱ> []XYZ[ ޼bjbj $ΐΐO 555554iiihia )L])])])8*8*8*Ġf~58*8*8*8*8*55])]).1118*X5])5])18*11b?])ʺNi*p;VĞ<+R?5?8*8*18*8*8*8*8*R.R8*8*8*8*8*8*8*8*8*8*8*8*8*8*8*8* :  Pregnancy Reporting Form Joint R&D Office Fax No 020 7905 2201Initial Report  FORMCHECKBOX  Follow-up Report  FORMCHECKBOX Pregnancy 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.  HYPERLINK "http://www.childrenfirst.nhs.uk/teens/www.ich.ucl.ac.uk" \t "_blank"  INCLUDEPICTURE "http://www.childrenfirst.nhs.uk/images/logos/ich_logo05.gif" \* MERGEFORMATINET  Pregnancy Reporting Form  HYPERLINK "http://www.gosh.nhs.uk" \t "_blank"  INCLUDEPICTURE "http://www.childrenfirst.nhs.uk/images/logos/nhs_logo05.gif" \* MERGEFORMATINET  Please fax this form to the Joint Institute R&D Office on 020 7905 2201 within 24 hours of notification of the event Study detailsStudy title FORMTEXT       CTA/DDX/CTX No FORMTEXT      Joint ICH /GOSH R&D Office Project ID R&D number FORMTEXT      EudraCT number FORMTEXT       1) Patient details (Any information regarding female partners of trial patients should be entered in Other Pregnancy Information section)Patient initials FORMTEXT      Patient study number  FORMTEXT      Gender FORMCHECKBOX  Male FORMCHECKBOX  FemaleDate of Birth  FORMTEXT DD/MM/YYType of Report FORMCHECKBOX  Initial FORMCHECKBOX  Follow-upHeight  FORMTEXT       cmWeight  FORMTEXT       kgHas CI been informed? FORMCHECKBOX  Yes  FORMCHECKBOX  NoWas study unblinded? FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Not Applicable 2) Trial treatment Drug Name BrandDoseUnitFrequencyIs this full dose?RouteStart dateOngoing?End date FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX  Y  FORMCHECKBOX  N FORMTEXT       FORMTEXT DD/MM/YY FORMCHECKBOX  Y  FORMCHECKBOX  N  FORMTEXT DD/MM/YY FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX  Y  FORMCHECKBOX  N FORMTEXT       FORMTEXT DD/MM/YY FORMCHECKBOX  Y  FORMCHECKBOX  N FORMTEXT DD/MM/YY FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX  Y  FORMCHECKBOX  N FORMTEXT       FORMTEXT DD/MM/YY FORMCHECKBOX  Y  FORMCHECKBOX  N FORMTEXT DD/MM/YYMost recent cycle number  FORMTEXT      Date last treatment given before pregnancy confirmation  FORMTEXT DD/MM/YY 3) Concomitant Medications?  FORMCHECKBOX  Y  FORMCHECKBOX  N (Only include drugs given within last 30 days. Continue on separate sheet if necessary. Continued on separate sheet?  FORMCHECKBOX Y  FORMCHECKBOX N Drug Name BrandIndication DoseUnitsFrequencyRouteStart dateOngoing?End date FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT DD/MM/YY FORMCHECKBOX  Y  FORMCHECKBOX  N  FORMTEXT DD/MM/YY FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT DD/MM/YY FORMCHECKBOX  Y  FORMCHECKBOX  N FORMTEXT DD/MM/YY FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT DD/MM/YY FORMCHECKBOX  Y  FORMCHECKBOX  N FORMTEXT DD/MM/YY FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT DD/MM/YY FORMCHECKBOX  Y  FORMCHECKBOX  N FORMTEXT DD/MM/YY 4) Pregnancy Information  Start date of last menses  Date pregnancy confirmed Method of diagnosis Anticipated date of childbirth Mother consented for pregnancy monitoring FORMTEXT DD/MM/YY 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defects (provide details in Other Pregnancy Information section below)Date of above outcome FORMTEXT DD/MM/YYDate of deliveryGestation (weeks)Mode of deliveryGenderWeight (Kg)Antenatal ProblemsPostnatal Problems FORMTEXT DD/MM/YY FORMTEXT       FORMTEXT       FORMCHECKBOX  Male  FORMCHECKBOX  Female FORMTEXT       FORMTEXT       FORMTEXT       Other Pregnancy Information (concurrent conditions, medical history, complications during birth, birth defects etc)  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       Past Pregnancy History  Date of Delivery Gestation (weeks)Mode of DeliveryGenderWeight (Kg)Antenatal ProblemsPostnatal Problems FORMTEXT DD/MM/YY FORMTEXT       FORMTEXT       FORMCHECKBOX  Male  FORMCHECKBOX  Female FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT DD/MM/YY FORMTEXT       FORMTEXT       FORMCHECKBOX  Male  FORMCHECKBOX  Female FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT DD/MM/YY FORMTEXT       FORMTEXT       FORMCHECKBOX  Male  FORMCHECKBOX  Female FORMTEXT       FORMTEXT       FORMTEXT       Signature PI or other participating clinicians only  FORMTEXT      Print name  FORMTEXT      Date of report  FORMTEXT DD/MM/YY For Sponsor / R&D Office use only Date event reported  FORMTEXT DD/MM/YYDate event reviewed  FORMTEXT DD/MM/YY Event No  FORMTEXT       Assessment of expectedness: (Was the event listed in the study protocol, SmPC or Investigator s Brochure?)  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