Pregnancy Testing Clause Samples

Pregnancy Testing. For women of child-bearing potential, a serum β-hCG pregnancy test will be performed during screening and a serum or urine β-hCG pregnancy test will be performed within 48 hours before baseline. Results must be available and confirmed to be negative before the subject is eligible for randomization in the study. Pregnancy testing is to be repeated during the study any time pregnancy is suspected. All subjects of reproductive potential must agree to adequate birth control from the time the screening pregnancy test is performed through 3 months after the final study drug dose. Study drug is to be discontinued for any subject with positive pregnancy test findings; see Section 12.2.6 for details regarding management of any pregnancies during the study. Women of non-child-bearing potential are to have this documented as part of the medical history.

Pregnancy Testing. For women with reproductive potential: serum or urine -HCG (urine test must have a sensitivity of 25-50 mIU/mL). After screening and entry, complete pregnancy testing only when pregnancy is suspected except as noted below.

Pregnancy Testing. All WOCBP will have a SPT at the Screening and at Week 16/Early Termination visits and UPT at Injection visit pre-treatment. If any result is positive prior to treatment, the subject will not be allowed to participate. The results of the UPTs for WOCBP will be evaluated at the trial center. WOCBP must use an effective method of birth control during the course of the trial, such as the oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine coil, intrauterine device, tubal ligation, barrier method used WITH an additional form of contraception (e.g., sponge, spermicide or condom), abstinence, no heterosexual intercourse, or has a vasectomized partner. A female is considered to be of childbearing potential UNLESS she is post-menopausal (no menses for 12 consecutive months) or without a uterus and/or both ovaries. Before enrolling WOCBP in this clinical trial, Investigator must review guidelines about study participation for WOCBP. The topics should generally include: • Informed consent document • Pregnancy prevention information • Risks to unborn child(ren) • Any drug interactions with hormonal contraceptives • Contraceptives in current use • Guidelines for the follow-up of a reported pregnancy Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during participation in this clinical trial and the potential risk factors for an unintentional pregnancy. The subject must sign the informed consent document stating that the above-mentioned risk factors and the consequences were discussed with her.

Pregnancy Testing. A urine pregnancy test will be conducted at Visit 1 and at Visits 6, 10 and 16 (48, 96 and 158 weeks from Visit 2) in all women of childbearing potential. Subjects with a positive pregnancy test should be withdrawn or excluded from entry to the study. If a subject becomes pregnant during the course of the study she must be withdrawn.

Pregnancy Testing. All female subjects of childbearing potential must have a negative pregnancy test (urine or serum) at Screening and within 72 hours of the first dose of study treatment. Subsequent pregnancy tests performed every 4 weeks after first dose of study treatment may be either urine or serum. Positive urine tests are to be confirmed by serum testing.

Pregnancy Testing. Medical services during pregnancy and post-partum;

Pregnancy Testing. Diagnosis and treatment of sexually transmitted diseases;

Pregnancy Testing. A RhoGAM injection for all pregnant women who have a negative RH factor according to the established protocol;

Pregnancy Testing. For females of childbearing potential, a negative serum human chorionic gonadotropin (hCG) pregnancy test must be obtained < 3 days prior to Cycle 1 Day 1 and at the EoT Visit. Test sensitivity for hCG must be ≥ 25 mIU/mL. Pregnancy testing is to be performed as clinically indicated at the discretion of the Investigator during the study.