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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 were collect 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  SDTMIG Section 4.4.7, Use of Relative Timing Variables. 

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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 applicant’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 study treatmentproduct exposure. Three AEs were reported for this subject. This SDTM dataset used AEENRF to represent Ongoing events. . More information can be found in  SDTMIG ongoing events. Expected variables (e.g., AELLT, AELLTCD, AEPT, AEPTCD, AEHLT, AEHLTCD, AEHLGT, AEHLCTCD, AEBDSYCD, AESOC, AESOCCD) are not included to save space.  

The applicant also collected information about whether the event was associated with a device. These subjects did not have any device-related issues. See Section 3.3.3.4, Tobacco Product Events and Malfunctions, for an example of device-related eventsSection 4.4.7, Use of Relative Timing Variables.