" /> Clinical Trial Pregnancy Report Documentation - CISMeF





Preferred Label : Clinical Trial Pregnancy Report Documentation;

NCIt related terms : Pregnancy Report; Preg Rept;

Alternative definition : CareLex: Documentation that presents and summarizes the relevant data related to a pregnancy and outcome as experienced by a female subject in a clinical trial, or by the partner of a male subject in a clinical trial. Reports may include but are not limited to specific regulatory forms and supporting data, reporter correspondence, associated note-to-files, source documentation, case logs, case unblinding form, narratives, and/or safety database case printouts. [Adapted from TMF-RM]; CDISC: Documentation pertaining to a pregnancy and its outcome as experienced by the female subject, or by the partner of the male subject during the clinical trial.;

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07/05/2025


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