?:definition
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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]
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