Assessing an ASCO Decision Aid for Improving the Accuracy and Attribution of Serious Adverse Event Reporting From Investigators to Sponsors

Mileham, KF; Schenkel, C; Chuk, MK; Buchmeier, A; Perez, RP; Hurley, P; Levit, LA; Garrett-Mayer, E; Davis, C; Bruinooge, SS; Vose, J

Schenkel, C (reprint author), Amer Soc Clin Oncol, 2318 Mill Rd, Alexandria, VA 22314 USA.

JOURNAL OF ONCOLOGY PRACTICE, 2019; 15 (12): 658

Abstract

PURPOSE Investigators often send reports to sponsors that incorrectly categorize adverse event (AE)s as serious or attribute AEs to investigational dr......

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