PPT-FDA’s Clinical Investigator Course

Preparing an IND Application CBER Breakout Session Donald W Fink Jr PhD Division of Cellular and Gene Therapies Office of Tissue and Advanced Therapies Center for Biologics Evaluation and Research. 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. Educational Material. Returning . Plain Language Summary . Results. Overview of . P. lain . L. anguage Summary . “Translates” the technical results of clinical trials into easy-to-understand language. 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. Frances Richmond . Director International Center for Clinical Trials. And you are…. The principal investigator of a company-sponsored trial?. The principal investigator of an investigator-sponsored trial?. 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.. Director of Research Operations. Neurological Clinical Research Institute (NCRI). Massachusetts General Hospital (MGH). Dixie Ecklund, RN, MSN, MBA, CCRC. Director of Operations. Clinical Trials Statistical & Data Management Center. x0000x0000Clinical Investigator Training Coursex0000x0000Clinical Investigator Training Coursex0000x0000Clinical Investigator Training Coursex0000x00008x/MCIxD 0 x/MCIxD 0 --- but the diagnosis of so n and Research or CBER conducting clinical research are also referred to as Good Clinical Practices or regulations for nonclinical laboratories compliance regulations during inspections sure that EDISON NJ 08837 MTFBIOLOGICSORG A NON-PROFIT ORGANIZATION Equal Opportunity Employer Request for Proposals - 2021 Clinical Research GrantMTF Biologics offers research grants to fund novel r 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. for Strengthening . the . Investigator Site . Community”. Once you’ve logged into WebEx, . please select one of the following . audio options. :. Call Using Computer. I Will Call In. DO NOT SELECT . 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.