What is considered child bearing potential?
A woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant. This includes women on oral, injectable, or mechanical contraception; women who are single; women whose husbands have been vasectomized or whose husbands have received or are utilizing mechanical contraceptive devices.
What is childbearing potential age?
However, to define women of childbearing age, or childbearing potential, a standard age range (often ages 16–49) is typically chosen.
What does non child bearing potential mean?
Women who wish to breast feed are not eligible for thestudy” “Females must be of non-childbearing potential. Women of non-childbearing potential are defined as those who have no uterus, ligation of the fallopian tubes, or permanent cessation of ovarian function due to ovarian failure or surgical removal of the ovaries.
Is pregnancy an adverse event in clinical trials?
Although pregnancy itself is not considered an adverse event or a serious adverse event, the pregnant participant or the partner of a male participant should be followed until termination or to term to ensure absence of congenital anomaly or birth defect that may have resulted from maternal exposure or transmission of …
Is pregnancy an AE?
Although Exposure During Pregnancy is not considered an SAE, it may result in an SAE. Even when there is no associated SAE, Exposure During Pregnancy is always reportable.
Why do radiologists ask when your last period was?
The primary aim for asking the LMP is to confirm the status of pregnancy in women of child bearing age capacity. Who asks the woman for her LMP? The radiographer or the attending radiologist are required to ask the woman who is of child bearing capacity whether she is pregnant and the date of her LMP.
What happens if you get an xray and didn’t know you were pregnant?
Remember that the possibility of any harm to you and your unborn child from an x-ray is very small. There are, however, rare situations in which a woman who is unaware of her pregnancy may receive a very large number of abdominal x-rays over a short period. Or she may receive radiation treatment of the lower torso.
Is death an SAE?
A Serious Adverse Event (SAE) is defined by FDA and NCI as any adverse drug event (experience) occurring at any dose that in the opinion of either the investigator or sponsor results in any of the following outcomes: death, a life threatening adverse drug experience, inpatient hospitalization or prolongation of …