Keyword: serious events

Management and Reporting of Adverse Events (AE), Serious Adverse Events (SAE), Unanticipated Adverse Device Effects (UADE), and Unanticipated Problems (UaP) Standard Practice Guideline

Study-specific, local, and federal guidelines for AEs, SAEs, UADEs, and Unanticipated Problems to maintain regulatory congruence and integrity in research practice

Keyword: serious events

Management and Reporting of Adverse Events (AE), Serious Adverse Events (SAE), Unanticipated Adverse Device Effects (UADE), and Unanticipated Problems (UaP) Standard Practice Guideline

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