PPT-SoCRA Review: Investigator Roles and Responsibilities in Clinical Research

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. 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). Review: Investigator Roles and Responsibilities in Clinical Research. John Naim, PhD. Director. Clinical Trials Research Unit. West Virginia University. March 20, 2015. West Virginia Clinical and Translational Science Institute. 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). 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 . 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. 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:. TN-CTSI. Derita Bran, BSN, RN, CCRC. Molly Rolen, BSN, RN, CCRP. Research Reflection series co-sponsored by . TN-CTSI and UTHSC Office of Research Development. 1. Disclaimer. This is a general slide presentation and should not be considered all- inclusive of a researcher’s responsibilities. 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. 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.. 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...