Pregnancy Screen Clause Samples
The Pregnancy Screen clause establishes requirements for determining whether an individual is pregnant, typically as part of a medical, employment, or research process. This clause may specify the timing, method, and responsible party for conducting pregnancy tests, such as requiring a negative test result before participation in a clinical trial or certain job duties. Its core function is to ensure safety and compliance with legal or ethical standards by identifying pregnancies that could affect eligibility or risk.
Pregnancy Screen. Serum pregnancy tests are required for female patients of childbearing potential.
Pregnancy Screen. All WCBP will complete a serum beta-human chorionic gonadotropin (β-hCG) or urine pregnancy test within 4 days before the first dose of study drug and urine or serum pregnancy tests within 4 days of each study drug administration and at the 30-Day Follow-up visit. It is recommended to perform monthly pregnancy tests for 3 months after the last dose of MIRV. Additional testing may be performed in accordance with institutional requirements or local regulation. Pregnancy tests must be negative for the patient to be enrolled and to continue to receive the study drug (Table 2). If a patient becomes pregnant or suspects pregnancy while participating in this study, the Investigator and Sponsor must be informed immediately (Section 8.2.2) and the patient will be withdrawn from study drug. See Section 8.2.2 for more details.
Pregnancy Screen. All WCBP will complete a serum beta-human chorionic gonadotropin (β-hCG) or urine pregnancy test within 4 days before the first dose of study drug and urine or serum pregnancy tests within 4 days prior to Day 1 of each cycle and at the 30-day Follow-Up visit. It is recommended to perform monthly pregnancy tests for 3 months after the last dose of MIRV and for 6 months after the last dose of chemotherapy. Additional testing may be performed in accordance with institutional requirements or local regulation. Pregnancy tests must be negative for the patient to be enrolled and to continue to receive the study drug (Table 2, Table 3, and Table 4). If a patient becomes pregnant or suspects pregnancy while participating in this study, the Investigator and Sponsor must be informed immediately (Section 9.2.2) and the patient will be withdrawn from study drug. See Section 9.2.2 for more details.
Pregnancy Screen. Females of reproductive potential defined as women who have not been postmenopausal for at least 24 consecutive months (i.e., who have had menses within the preceding 24 months), or women who have not undergone surgical sterilization; specifically, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, hysteroscopic sterilization, and/or tubal ligation, must have a negative pregnancy test at Screening, within the 24 hour period prior to Day 1 and at all other time points indicated in Table 3, or as applicable. At Screening a serum beta human chorionic gonadotropin or urine dipstick pregnancy test will be performed. A urine dipstick pregnancy test will be performed at all other time points. All post-menopausal females will have an FSH test at Screening.