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The PMTA rule defines adverse experiences. In clinical trials, the terminology adverse events is used. Some of the procedures in the collection of adverse experiences in tobacco product studies follow the convention used for collecting adverse events (e.g., coding dictionaries, defintion of severity, etc). Thus, the terms adverse event may be used as a "synoymn" 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 adverse event collection (e.g., collecting pre-treatment events experiences related to trial conduct, not collecting events that are assessed as efficacy endpoints). Events included in the AE domain should 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 event experinece 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 events experineces that occurred after informed consent is obtained. Adverse events 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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