Reproductive risk, contraception, and pregnancy monitoring

The manuals converge on a clear core expectation, pregnancy risk is actively screened for, contraception is confirmed, and pregnancy is treated as a safety event that must be reported promptly. Across the extracts, pregnancy testing is built into screening and later visits, participants of childbearing potential are checked for eligibility, and pregnancy or suspected exposure leads to withdrawal or discontinuation of study treatment. Several manuals also link this to follow-up, including documentation of pregnancy outcomes and reporting to the sponsor or within protocol timelines. They also agree that reproductive counselling is part of the role, not a one-off formality. The manuals recommend explaining contraception requirements, maintaining them through the relevant treatment or post-dose windows, and addressing sex-specific precautions such as condom use for men, sperm donation restrictions, and highly effective contraception for women of childbearing potential. Some sources also extend this to breastfeeding exposure and local regulatory requirements. The main differences are in emphasis and timing. Some manuals specify serum and urine pregnancy testing, while others mention urine testing only. Reporting timelines vary, from immediate reporting, to within 24 hours, to reporting within protocol timelines. A few sources explicitly mention exclusion of pregnant or nursing participants, or pregnancy and breastfeeding as exclusion criteria, while others focus more on ongoing monitoring, exposure-in-utero procedures, or post-dose contraception windows.