PPT-CLINICAL RESEARCH STUDY TEAM

CLINICAL TRIAL STUDY TEAM A Clinical Trial study team is a research team that test a new medical treatment or a new way of using an existing treatment to see if it will be a better way to prevent and screen for diagnose or treat a disease. Why are we doing this?. . Reporting Period . Q1 13/14 – 01/07/2012 . to . 30/06/2013. Through . the NIHR (National Institute for Health Research) th. e . Government wishes to see a dramatic and sustained improvement in . Challenges . of . FDA-Regulated . Research. Pat Ward & Diane Wilson. UMMS Regulatory Affairs. With special thanks to Kara Morgenstern, HSLO. Human Subject Research at UM. All – Governed by University policy. Darlene Kitterman, MBA, Director, . Investigator Support & Integration Services (ISIS), Oregon Clinical & Translational Research Institute (OCTRI). Audience. This course is intended for “department administrative staff”—including clinical research coordinators, department administrators, division managers, department fiscal managers, department effort coordinators, etc.. of the . Clinical Research . Team. Kathleen O’Malley RN, BSN, CCRP. Manager of Education and Training. Jefferson Clinical Research Institute. Kathleen.omalley@jefferson.edu. Learning Objectives:. Name the required and possible members of the research team. PEARLS December 9, 2016. Panelists. Saadia Khizer, MBBS, MPH, CCRC, . Lead Research Coordinator, Scottish Rite (saadia.khizer@choa.org). Jaclyn M. Smith, MBA, CCRP. , Research Manager, Aflac (Jaclyn.smith@choa.org). Lea H. Becker, MT(ASCP); . Elaine Dube, CCRP; Weitao . Wang, Kaitlyn . Brill, . Robert . O’Connor, MD. University for Virginia Health System, Department of Emergency Medicine. Introduction. Problems. wabat@southern-med.com. PLATINUM DIVERSITY STUDY. National Co-PI. The first U.S. national study prospectively evaluating the clinical outcomes of 1,500 women and minorities undergoing coronary artery stenting. Enrollment completed. Fully funded by Industry. Marianne Kearney. Director of Research Operations Neurological Clinical Research Institute. Massachusetts General Hospital. Goals of successful collaboration in multicenter clinical trials. Efficient implementation of the trial across multiple clinical sites. Prepared by Christine Hunter, BSN Baylor College of Medicine . and . Karen Williams, CCRP. Northwestern University. 1. What is research? . Research is defined by the Department of Health and Human Services as a . The Pros and Cons. Natalie Diaz, MD. Pacific Neuroscience Institute - Torrance. WHAT IS CLINICAL RESEARCH. Research asks and tests a question about a condition with goal to gain more knowledge or find betters ways to diagnose, prevent and treat it. . Act as the main line of communication between the team membersand will beresponsible for project start up activities and coordination between regulatory authorities, ethics committees and sponsor. As -differences from Basic Research-. Tetsuo Ashizawa, M.D.. NIH definition of clinical research. Research with human subjects that is:. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. It includes:. November 9-10, 2017. San Diego, CA . Heather M. Quinlan-Baron, . Grants Manager, Endocrinology . February 26, 2018. What is . The Society of Clinical Research Associates (SOCRA) is a non-profit, charitable and educational membership organization committed to providing education, certification, and networking opportunities to all persons involved in clinical research activities. SOCRA, the premier educational organization for oncology site coordinators, has now emerged as a leading educational organization for clinical researchers in all therapeutic areas, supporting industry, government and academia.. Agenda. Reducing Administrative Burden - Administrative Fees. Billing Coverage Analysis. Research Billing Review. DocuSign – . eConsent. . Advarra Electronic Data Capture. Subject Injury language in the ICF.