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. 2020 Nov 3;59(1):26–30. doi: 10.5414/CP203788

Table 1. Measures implemented in early-development clinical trials to mitigate the risk of unintended pregnancies.

Topic Responses
Methods routinely used to avoid unintended drug exposure during pregnancy in clinical trials (44 respondents) Adequate contraceptive methods in in/exclusion criteria: 43
In female trial participants, pregnancy test at screening: 39
In female trial participants, pregnancy test before first dose: 37
In female trial participants, documentation of last menstrual period (LMP) at screening: 18
In female trial participants, documentation of LMP before first dose: 5
Routine compliance checks whether subjects used contraceptive methods, how and when they used contraceptive methods (42 respondents) Yes: 23
No: 19
Procedures in place on what to do if contraceptive methods failed (42 respondents) Yes: 25
No: 17
Training physicians in instructing trial participants on how to use the contraceptive methods as specified in the clinical trial protocol (42 respondents) Yes: 26
No: 16