PPT-Investigator Responsibilities for Research

Shannon Simmons BA CIP March 14 2014 Process Improvement Team Vanderbilt Human Research Protections Program Agenda Review Investigator Responsibilities Discuss FDA Warning letters Q amp A. 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). 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. 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). Jeffrey M. Cohen, Ph.D. CIP. Chief Executive Officer. HRP Consulting Group. Overview. History. Human Research Protection Program. Investigator Responsibilities. 2. © HRP Consulting Group. History. 3. 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. End of Year Report. Why was the request made:. Bent, Crowley, and Huerfano Counties do not have the expertise or resources to adequately investigate member fraud and settle these cases through repayment agreements or criminal/civil court. . How to Change the Principal Investigator (PI) in IRBNet and the Part I cover sheet 1 of 5 The process to change the PI is similar whether you are preparing a new submission or an amendment request to change the PI. . SYFTET. Göteborgs universitet ska skapa en modern, lättanvänd och . effektiv webbmiljö med fokus på användarnas förväntningar.. 1. ETT UNIVERSITET – EN GEMENSAM WEBB. Innehåll som är intressant för de prioriterade målgrupperna samlas på ett ställe till exempel:. --- 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. Kathleen O’Malley RN, BSN, CCRP. Manager of Education and Training. Jefferson Clinical Research Institute. Kathleen.omalley@jefferson.edu. Stephen . Klasko. , MD, MBA. President and CEO of TJU AND Jefferson Health System. Beth Taraban. Director. TTUHSC Research Integrity Office . Some Definitions. Financial interest. : Anything of monetary value, whether or not the value is readily ascertainable;. Significant financial interest. 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. Office of Grants and Contracts. Presenter: Stephanie Chandler-Thompson. Roles and Responsibilities . The Office of Grants and Contracts is responsible for ensuring proper review of sponsored project proposal submissions and stewardship of awarded...