Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

Example

This is an example of a CRF used to collect all adverse experineces experiences that occurred after informed consent is obtained. Adverse events experiences were collected using free-text. This CRF was designed to allow the applicant to use either AEENRF or AEENRTPT to represent an event that was ongoing. 

Include Page
CDASH Example.Adverse Experiences
CDASH Example.Adverse Experiences
 

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

Include Page
SDTM Example.Adverse Events
SDTM Example.Adverse Events

...