This course will offer best practices when conducting trials using FDA approved and non-approved devices. It will cover the IDE application process and the obligations of the sponsor-investigator once the IDE application is filed with the FDA. Speakers include Erika Segear Johnson, PhD RAC (Duke) and Amy Franklin, BS (UNC).
Stuart A. Aaronson, MD, Professor and Founding Chair Emeritus, Department of Oncological Sciences, Icahn School of Medicine at Mount Sinai
Rachel Bleich, CBMC
This course will offer best practices when conducting clinical trials using FDA approved and non-approved drugs or substances (including botanicals and biologics). It will cover the IND process and the regulatory obligations of the sponsor- investigator once an IND is filed with the FDA.
Karin Leiderman, PhD, Assistant Professor, Department of Applied Mathematics, University of California, Merced
Anna Marie Pyle, Ph.D. Yale University
Office hours for patient-reported outcomes (PRO) research Q&A and impromptu demonstrations of PRO-Core systems. No RSVP required!
Top 10 Writing Mistakes
Theresa Raphael-Grimm, PhD, CNS. Theresa has over 30 years if experience as a clinician and educator. As a seasoned psychotherapist and through her efforts with the UNC Comprehensive Cancer Support Center, she has worked closely with cancer patients and their families to help them navigate the emotional distress that often accompanies cancer diagnosis and treatment. She holds a masters and doctoral degree from the University of Pennsylvania and teaches in UNC's Schools of Nursing and Medicine. She is the author of the 2015 book: The Art of Communication in Nursing and Healthcare: An Interdisciplinary Approach.
Identification & Management of Late Effects of Cancer Treatment