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Comment: Changed "clinical trial" to "clinical study" (TOBA-160)
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The PMTA rule defines adverse experiences. while in clinical trialsstudies, the terminology adverse events is used. 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, defintion of severity, etc). Thus, the terms adverse event may be used as a "synoymn" for adverse experiences in this document.         

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