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Adverse event terms may be captured either as free text or via a prespecified list of terms.
This is an example of a CRF used to collect all adverse experiences that occurred after informed consent is obtained. Adverse experiences where collected using free-text. This CRF was designed to allow the sponsor to use either AEENRF or AEENRTPT to represent an event that was ongoing.
Include Page CDASH Example.Adverse Events CDASH Example.Adverse Events
This SDTM dataset used AENRTPT. More information can be found in the section Use of Relative Timing Variables (Copy)
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