Adverse event reporting is a critically-important responsibility of study coordinators and investigators. This course discusses Adverse Events (AEs), Serious Adverse Events (SAEs) and Medical Events of Interest (MEOI's) and explains how they should be documented in the case report forms for the CLEAR III study. Additional topics covered included intensity grading, causality and the functions of the safety team.
Neurocrit Care. 2018 Jan 2
The Incidence of Catheter Tract Hemorrhage and Catheter Placement Accuracy in the CLEAR III Trial
Müller A, Mould WA, Freeman WD2, McBee N, Lane K, Dlugash R, Thompson R, Nekoovaght-Tak S, Madan V1, Ali H, Stadnik A, Awad I, Hanley D, Ziai WC; CLEAR investigators.
Int J Stroke. 2018 Jan;13(1):11-23
Fibrinolytic for treatment of intraventricular hemorrhage: A meta-analysis and systematic review
Baker AD, Rivera Perla KM, Yu Z, Dlugash R, Avadhani R, Mould WA, Ziai W, Thompson RE, Staykov D, Hanley DF
Neurology. 2017 Oct 10;89(15):1553-1560
CSF inflammatory response after intraventricular hemorrhage
Fam MD, Zeineddine HA, Eliyas JK, Stadnik A, Jesselson M, McBee N, Lane K, Cao Y, Wu M, Zhang L, Thompson RE, John S, Ziai W, Hanley DF, Awad IA; CLEAR III Trial Investigators
J Magn Reson Imaging. 2017 Aug 9
Quantitative susceptibility mapping as a monitoring biomarker in cerebral cavernous malformations with recent hemorrhage
Zeineddine HA, Girard R, Cao Y, Hobson N, Fam MD, Stadnik A, Tan H, Shen J, Chaudagar K, Shenkar R, Thompson RE, McBee N, Hanley D, Carroll T, Christoforidis GA, Awad IA