NCI GUIDELINES FOR INVESTIGATORS - National Cancer …
NCI Guidelines: Adverse Event Reporting Requirements February 29, 2012 Page 5 2 Tools for AE Reporting: 2.1 Basic Terminology: 2.1.1 Adverse Event (AE or Adverse Experience): Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and
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