SDTM Example.Nicotine Exposure Double-Dummy design

In this study, subjects were randomized to either nicotine replacement patches or ENDS devices using e-nicotine liquid cartridges. In order to maintain the blind, subjects used both the nicotine replacement patches and the ENDS devices. Subjects were requested not to smoke, but the number of regular cigarettes used were collected. Subject were seen every day for 15 days. The nicotine patch was applied, at rotating sites, and the nicotine cartridge was replaced every day. The cartridge was weighed when dispensed and upon return. On days, 1, 5, and 10. subjects remained in the clinic for 4 hours for collection of biomarkers. On these days, a new ENDS nicotine cartridge was inserted and 10 puffs were taken over 10 minutes, and not used for the remaining collection period. A new cartridge was inserted at the end of the 4 hour collection period.  A nicotine replacement patch was applied prior to using the ENDS device on these days.     

The SU domain was used to represent the number of cigarettes used, but is not shown.  

In this study, the weight of the contents in the cartridge was tracked. A Product Accountability (DA) domain was submitted to represent dispensed and returned weights of each cartridge. Only a few rows are shown. The produt accountability information was not provided for the nicotine replaement patches.    

EC was used to represent the collected exposure data since a double dummy design was used. The EX domain was used to represent the subject's exposure to the actual product containing nicotine. The sponsor represented each cartridge and patch used. The dose was represented as "1" to indicate one cartidge or patch. The actual date and specific time of usage of the cartridge was recorded on days 1, 5, and 10, while only the date of usage was reccorded on other days.