What is considered child bearing potential?

What is considered child bearing potential?

Women of childbearing potential (WOCBP) is defined as any woman or adolescent who has begun menstruation. A post-menopausal woman is defined as a woman who is over the age of 45 and has not had a menstrual period for at least 12 months.

What is the child bearing?

Definition of childbearing : of or relating to the process of conceiving, being pregnant with, and giving birth to children women of childbearing age. Other Words from childbearing Synonyms Learn More About childbearing.

What does non childbearing potential mean?

“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.

What is the NIH Revitalization Act?

The NIH Revitalization Act of 1993, PL 103-43, signed into law on June 10, 1993, directed the NIH to establish guidelines for inclusion of women and minorities in clinical research.

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 …

What does child bearing hips mean?

In the simplest terms, childbearing hips refers to a woman’s pelvic structure. This expression is often used to describe women who have larger or wider hips. Pelvic shapes aren’t one size fits all. Rather, they can vary considerably in shape and size from woman to woman.

Is pregnancy a SAE?

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.

Is pregnancy an AE?

Which group must approve recruitment and retention materials for any federally funded research prior to utilization in a clinical study?

IRB review
As a general rule, any recruitment materials that will be seen by research subjects require IRB review and approval.

What is the main source of federal funds for biomedical research?

Federal sources remain the largest contributor to academic biomedical research expenditures, accounting for 65% of expenditures, followed by institutional funds (18% of expenditures). The distribution of NIH funding among the most heavily funded institutions has remained almost unchanged from 1994 to 2007.

Who is the patient in a pregnancy exposure report?

Pregnancy exposure registries are not designed to provide direct benefit and should not represent any risk to either the pregnant woman or the fetus; therefore, the decision to participate in the registry rests solely with the pregnant woman (see subpart B of 45 CFR part 46).