PPT-Clinical Investigator Training Course

Issues in Clinical Trial Design for Rare Diseases Jonathan C Goldsmith MD FACP Associate Director Rare Diseases ProgramOffice of New Drugs Center for Drug Evaluation and Research FDA November 7 2016. 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. Career. Henry Khachaturian, Ph.D.. Training Program Policy Officer. Division . of Biomedical Research Workforce . OEP. , OER, . NIH. hk11b@nih.gov. National Institutes of Health. 2. NIH is made up of 27 Institutes and Centers, each with a specific research . . . Trainee:. . . . Name. Trainer:. Mr. . Jean-Paul Eycken. CEO . FormaliS. SA. This ICH . E6(R2) . GCP Investigator Site Training meets . the Minimum Criteria for . 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.. 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 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. 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.