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. Sponsor Responsibilities . Based on ICH . E6. GCP Guidance (Section. 5). Purpose:. To . provide an overview of Sponsor Responsibilities . to study sites. Audience/User:. NIDCR. study staff, including PIs, Sub-Is, and Site . Challenges . of . FDA-Regulated . Research. Pat Ward & Diane Wilson. UMMS Regulatory Affairs. With special thanks to Kara Morgenstern, HSLO. Human Subject Research at UM. All – Governed by University policy. 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. . . Trainee:. . . . Name. Trainer:. Mr. . Jean-Paul Eycken. CEO . FormaliS. SA. This ICH . E6(R2) . GCP Investigator Site Training meets . the Minimum Criteria for . 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. GCP: . Tips on Clinical Trial Conduct and . Preparing for FDA Inspection . Susan Leibenhaut, M.D.. Office of Scientific Investigations (OSI) . CDER/FDA. February 28, 2019. Good Clinical Practice - GCP. 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.. x0000x0000Clinical Investigator Training Coursex0000x0000Clinical Investigator Training Coursex0000x0000Clinical Investigator Training Coursex0000x00008x/MCIxD 0 x/MCIxD 0 --- but the diagnosis of so 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:. 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.