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Wednesday, June 3, 2009
ORD Guidance on Pregnancy in Human Subject Research 06/03/09. The VHA Office of Research and Development (ORD) has received questions from drug companies and investigators about collecting information on pregnant females when they are study subjects, study subjects who have withdrawn from the study, or pregnant partners of male research subjects. The issue of pregnancy and the use of Pregnancy Category C drugs is important. Many prescription and over-the-counter drugs marketed drug for use in clinical care are labeled as Pregnancy Category C by the FDA.* When Category C drugs are administered to women enrolled in research studies, the information collection must be part of the study and the women must remain in the study while the information is collected. VA Office of Research & Development
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