What is childbearing 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 Pregnancy exclusion?

However, thirty-six states currently have “pregnancy exclusion” laws that require physicians to void the advance directives of pregnant women receiving life-sustaining treatment.

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 it ever appropriate to include a pregnant woman in a clinical trial?

In general, pregnant women are excluded from drug development clinical trials; however, in certain situations, it may be scientifically and ethically appropriate to include pregnant women in a clinical trial. Health and Human Services (HHS) Human Subject Protection regulations, including pregnant women.

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.

How long does the new drug process takes?

There is no typical length of time it takes for a drug to be tested and approved. It might take 10 to 15 years or more to complete all 3 phases of clinical trials before the licensing stage.

What values underlie the statute making a pregnant woman’s healthcare treatment declarations of no effect while pregnant?

The “no effect” means that the law in one’s state does not allow one’s document that directshealthcare to take effect when one is pregnant. The underlying statute is that the unborn baby isnot in a position to make their own decision. Therefore, it is crucial to overrule the parent’swishes and rights.

What is considered an SAE?

A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any dose. Results in death. Is life-threatening. Requires inpatient hospitalization or causes prolongation of existing hospitalization. Results in persistent or significant disability/incapacity.

What is an AE in clinical trials?

5. • An adverse event (also referred to as an adverse. experience) can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporarily associated with the use of a drug, without any judgment about causality or relationship to the drug.