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Example

This is an example of a CRF used to collect all adverse events that occurred after informed consent is obtained. Adverse events were 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. 

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CDASH Example.Adverse Events
CDASH Example.Adverse Events
 

This SDTM dataset illustrates data collected on the example AE CRF above. This SDTM dataset used AENRTPT. More information can be found in the section  Section 2.8.7.6 Representing References and Relative Timing.

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SDTM Example.Adverse Events
SDTM Example.Adverse Events

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