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The PMTA rule defines "adverse experiences" in tobacco product studies, whereas clinical trials use the terminology "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, etc). Thus, the terms adverse event may be used as a "synonym" for adverse experiences in this document. |
The Adverse Events (AE) domain is based on the Events General Observation class. In tobacco product studies, AE is used for representing adverse experiences. The Food and Drug Administration in the premarket tobacco product applications (PMTA) Rule 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-treatment experiences 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.
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Adverse experience terms 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 is obtained. Adverse experiences were collected using free-text. This CRF was designed to allow the applicant to use either AEENRF or AEENRTPT to represent an event that was ongoing.
This SDTM dataset illustrates data collected on the example AE CRF above. This SDTM dataset used AENRTPT. More information can be found in Section 2.8.7.6, Representing References and Relative Timing.
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