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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. This SDTM dataset used MHENRTPT. More information can be found in  the section Use of Relative Timing Variables (Copy)

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This SDTM dataset illustrates data collected on the example AE CRF above,  AEs were coded using MedDRA, and the sponsor’s procedures include the possibility of modifying the reported term to aid in coding. The CRF was structured so that seriousness category variables (e.g., AESDTH, AESHOSP) were checked only when AESER is answered “Y.” In this study, the study reference period started at the start of product exposure. Three AEs were reported for this subject. This SDTM dataset used AEENRF to represent Ongoing events. More information can be found in  SDTMIG Section 4.4.7, Use of Relative Timing Variables. The expected variables (e,g,, AELLT, AELLTCD, AEPT, AEPTCD, AEHLT, AEHLTCD, AEHLGT, AEHLCTCD, AEBDSYCD, AESOC, AESOCCD) were not included to save space.  

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