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Title:  “New and Improved:  The Data and Safety Monitoring Committee”Objectives: Participants will:

1. Describe the role, scope and responsibilities of the DSMC
2. Describe the categories of risk assessment of protocols reviewed by the DSMC
3. Describe a process improvement project implemented by the DSMC at Massey Cancer Center

About the Speaker:   

A native of Canada, Dr. Mark G. Malkin, MD, FRCPC, FAAN, graduated from the Faculty of Medicine at the University of Toronto in 1979.  Following training in Internal Medicine and residency in Neurology, both at University of Toronto affiliated hospitals, Dr. Malkin completed a Neuro-Oncology fellowship at Memorial Sloan-Kettering Cancer Center in New York in 1988.  Dr. Malkin began his career as a faculty member in the Department of Neurology at Memorial Sloan-Kettering and Weill Cornell University Medical College, rising to the rank of Associate Clinical Member at Memorial and Associate Professor of Clinical Neurology at Cornell.  In 2004, he moved to Froedtert and the Medical College of Wisconsin in Milwaukee where he became Director of the Neuro-Oncology Program in 2007, and Professor of Neurology and Neurosurgery. In 2013, thanks to the generosity of the Reynolds Foundation, the opportunity arose to create a Division of Neuro-Oncology in the Department of Neurology at Virginia Commonwealth University (VCU) School of Medicine, and a Neuro-Oncology Program at the NCI-designated Massey Cancer Center.  Dr. Malkin is Professor of Neurology and Neurosurgery at VCU School of Medicine, William G. Reynolds, Jr. Chair in Neuro-Oncology, Member of the Developmental Therapeutics Program at Massey, and Director of the Neuro-Oncology Program at VCU and Massey.  In July 2014, Dr. Malkin was appointed to the Chair of the Data and Safety Monitoring Committee at Massey. Dr. Malkin is board certified in Neurology through the Royal College of Physicians of Canada (1984), and in Neuro-Oncology through the United Council of Neurological Subspecialties (2011).   Dr. Malkin’s research interests include clinical trials for brain tumor patients, advanced brain tumor imaging, the epidemiology of primary brain tumors, and quality of life studies in brain tumor patients.   During the course of his career, he has been the institutional Principal Investigator on 23 clinical trials.

Dr. Malkin has been a member of the Radiation Therapy Oncology Group (RTOG) since 2004 (now NRG), and participates in those meetings on a regular basis.  He is a member of the Translational Science Brain Cancer Subcommittee/Low-Grade Glioma Working Group, the Neurosurgical Subcommittee and the Brain Tumor Core Committee of the NRG.

CE:  1.0 CEU will be offered for this presentation for SOCRA members whom will receive a certificate of attendance.

Please share this announcement with your colleagues. SOCRA members and non‐members welcome!

Central Virginia SOCRA Chapter Co-chairs

Shirley Helm, MS, CCRP                           Patti Feldt, AAS, CCRP

804-628-2942                                             804-628-1902 

shirley.helm@vcuhealth.org                       pafeldt@vcu.edu