PPT-Tool: Training Presentation: Investigator Responsibilities and Good Clinical Practice

Based on ICH E6 GCP Guidance Sections124 amp 6 and 45 CFR 46 Protection of Human Subjects Purpose To provide an overview of Investigator Responsibilities and GCP to study sites. Training Presentation: Investigator Responsibilities and Good Clinical Practice (GCP). Based on ICH . E6. GCP Guidance (. Sections1.24. &. 6) . and 45 . CFR. 46: Protection of Human Subjects . 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. 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 . Each of us has a specific role . in . the course. Own your . role . – . know your . duties and . deliverables. Each of us will do a . presentation(s). We . expect an excellent presentation from everyone!. Investigator Safety. Instructor Name. Agency. Session Introduction. Learning Objectives. Upon completion of the session, you will be able to: . Describe security and safety concerns faced by investigative staff and ways they may be reduced.. Office of Human Subjects Research Institutional Review Board (IRB) Open House. Frederick W. Luthardt, DBE, MA. Manager, OHSR Compliance Monitoring Program. Suzanna Roettger, MA. Senior Compliance Monitoring Specialist. Version: 1.0/2017. 1. Good clinical Practices. Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected. . 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.. 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. 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. Purpose:. To . provide an overview of the . key roles and responsibilities of investigators and staff engaged in NIDCR-funded research. . Audience/User:. NIDCR. study staff, including PIs, Sub-Is, and Site Study Coordinators. 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.. t. raining. FLO-ELA . Tailored GCP . Training v5.0. What is Good Clinical Practice?. Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.