PPT-Investigator Responsibilities for Research

Jan Zolkower MSHL CIP CCRP January 13 2012 Review Investigator Responsibilities Discuss recent FDA Warning letters and OHRP Determination letters Review of Advanced Notice of Proposed Rulemaking ANPRM. Jan Zolkower, MSHL, CIP, CCRP. January 13, 2012. Review Investigator Responsibilities. Discuss recent FDA Warning letters and OHRP Determination letters. Review of Advanced Notice of Proposed Rulemaking (ANPRM). Shannon Simmons, BA, CIP. March 14, 2014. Process Improvement Team. Vanderbilt Human Research Protections Program. Agenda. Review Investigator Responsibilities. Discuss FDA Warning letters . Q & A. 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. Ethics and Conflict of Interest—NIH Rules. Title IX Sexual Harassment. New Intellectual Property Assignment Procedures. ETHICS AND CONFLICT OF INTEREST CHANGES AND NEW PHS-NIH RULES. Montana State University. 2011 Revised Regulation. FCOI Webinar for Grantees. Provided by the National Institutes of Health. November 30, 2011. Financial Conflict of Interest (FCOI) 2011 Revised Regulation. WMed HRPP . Investigator Responsibilities for . Clinical Trials Research . Introduction. This comprehensive, educational presentation for Clinical . Trials Research . is a resource tool provided by WMed Homer Stryker M.D. School of Medicine for researchers involved in sponsor- and/or investigator-initiated . Stephen Workman, MPH. September 2016. Thomas Jefferson University. Investigator responsibilities. Sponsor assessment of PI performance . What TJU does well. How PIs can be more impressive to sponsors. Based on ICH . E6. GCP Guidance (. Sections1.24. &. 6) . and 45 . CFR. 46: Protection of Human Subjects . Purpose:. To . provide an overview of Investigator Responsibilities and GCP. to study sites. Overview of Good Clinical Practices (GCP) . Investigator and Study Team Responsibilities. Miles McFann. IRB Administration. Training and Outreach. 2. Good Clinical Practice is the compilation of accepted ethical and scientific standards governing clinical research that ensure the integrity of data obtained and the protection of human research subjects.. Based on ICH . E6. GCP Guidance (. Sections1.24. &. 6) . and 45 . CFR. 46: Protection of Human Subjects . Purpose:. To . provide an overview of Investigator Responsibilities and GCP. to study sites. John Naim, PhD. Director. Clinical Trials Research Unit. West Virginia University. March 20, 2015. West Virginia Clinical and Translational Science Institute. Outline . Historical Perspective. Legal Framework. What Every Investigator. (and his/her research staff). Should Know about. Conducting. Human Research Activities. *. Based on David Lettermen’s Top Ten . PI Responsibility #1. In designing the study, the investigator should take into consideration the three underlying ethical principles for conducting research with human subjects as delineated in the. Derita: . dbran@uthsc.edu. Margaret: . mlynn@uthsc.edu. https://tnctsi.uthsc.edu/training-and-education/seminars-and-workshops/tn-ctsi-certification-exam-preparation-course/. Handout/. Reference sheets:. Presented by the . Research Quality Compliance Network.  . PRESENTERS. Ginger Bair, CCRP – QA/QC Coordinator, Office of Quality Compliance and CTSI. Josh Fessel, MD, PhD . –. . Senior Clinical Advisor, Division of Clinical Innovation, NCATS and NIH.