PPT-Responsibilities of the Principal Investigator

Anne Roussell RN adapted from MAGI Complion Presentation by Velma Marzinotto RN April 2018 1 References ICH E6 R2 Good Clini c al P r ac t i c es G. 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. 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). ABS). Principal Directors:. Fu Hu and Yun-han Chu. Co-Principal Investigators. Yu-tzung Chang, . Min-hua. Huang, . Kai-ping. Huang, …. 2017.03.17. 1. History of the ABS. 1976 Professor Fu Hu establishes Study Group on Political Systems and Change. 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. 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. 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.. PROJECT SUMMARY (See instructions): RELEVANCE (See instructions): Project/Performance Site Primary Location Organizational Name: DUNS: Street 1: Street 2: City: County: State: Province: Country: Zip/P 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. 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:. 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...