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Outstanding Issues
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The SDTM AE domain includes clinical data describing "any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment" (ICH E2A). In consultation with regulatory authorities, sponsors may extend or limit the scope of adverse event collection (e.g., collecting pre-treatment events related to trial conduct, not collecting events that are assessed as efficacy endpoints). Events included in the AE domain should be consistent with protocol requirements. Adverse event terms may be captured either as free text or via a prespecified list of terms.
The PMTA rule defines adverse experiences in tobacco product studies, whereas clinical trials use the term "adverse events". Some of the procedures in the collection of adverse experiences in tobacco product studies follow the conventions used for collecting adverse events (e.g., coding dictionaries, definition of severity). Thus, the term "adverse event" may be used as a synonym for "adverse experiences" in this document. |
In tobacco product studies, the Adverse Events (AE) domain is used for representing adverse experiences. The FDA's PMTA rule defines adverse experience as The Food and Drug Administration in the premarket tobacco product applications (PMTAs) defines “adverse experience” as any unfavorable physical or psychological effect in a person that is temporally associated with the use of or exposure to a tobacco product, whether or not the person uses the tobacco product, and whether or not the effect is considered to be related to the use of or exposure to the tobacco product. In consultation with regulatory authorities, applicants may extend or limit the scope of collection (e.g., collecting pre-exposure experiences related to trial conduct, not collecting events that are assessed as study endpoints). 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. .Adverse event terms In consultation with regulatory authorities, applicants may extend or limit the scope of event collection. Adverse events may be captured either as free text or via a prespecified list of terms.
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This is an example of a CRF used to collect all adverse experiences that occurred after informed consent |
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was obtained. Adverse experiences were collected using free |
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text. |
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The CRF was designed to allow the |
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applicant to use either AEENRF or AEENRTPT to represent an event that was ongoing.
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This SDTM dataset illustrates data collected on the example AE CRF |
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. This SDTM dataset used AENRTPT. |
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For more information, see Section 2.8.7.6, Representing References and Relative Timing.
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