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Events represented in the EM domain will be consistent with scientific and regulatory requirements. It is the applicant's responsibility to define an event and the appropriate collection period for events. This definition may vary based on product characterization and reporting of product safety. In consultation with regulatory authorities, applicants may extend or limit the scope of event collection. 

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-729
Records are specific to an individual tobacco product device. The entries may be related to 1 or many subjects, depending upon the type of tobacco product device and scope of its use. Applicants will ensure that appropriate regulatory guidelines for reporting  tobacco product device events are followed. If a coding dictionary is used, NSVs may need to be added to represent the various coding level variables defined in the dictionary. Event terms may be captured either as free text or via a prespecified list of terms.    

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