PPT-Decentralized Trials: Regulatory and Implementation Issues

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C Karen Jeans PhD CCRN CIP VHA Office of Research and Development ORD 2023 IRB and Research amp Development RampD Committee Chairs Workshop February 79 2023 Objectives

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Decentralized Trials: Regulatory and Implementation Issues: Transcript

C Karen Jeans PhD CCRN CIP VHA Office of Research and Development ORD 2023 IRB and Research amp Development RampD Committee Chairs Workshop February 79 2023 Objectives Define the term decentralized trials. (Centralized / Decentralized / . Eclectic. ). Member. Cho . Hyeon-il. / Go dong-sub / Oh . jae-heung. Table of Contents. Decentralized, Centralized. , Eclectic’s meaning. Decentralized . countries. most. pertinent aspects in a computer science perspective. Hugues Bersini . Jérémie Dubois-Lacoste. IRIDIA/ULB. Intro: My . three. . favourite. aspects. Distributed. – . Decentralized. – No . Anne Shere Wallwork, Senior Counselor for Strategic Policy, Office of Terrorist Financing and Financial Crimes. U.S. Department of the Treasury. Unclassified. The overall classification of this briefing is:. Data . Communications. Implementation . Team (DCIT. ). DCIT . #31 . PLENARY. DCL Trials Update. 3/13/2014. Matt Maki. DCL Trials Lead. DTAP Build 7.1 Schedule Update. Build 7.1 Limited Climb Via SID Compliance:. Mr. Ornstein. Willow Canyon High School. AP World History. Answer. How is Centralized Power different from De-Centralized Power?. Decentralized Power. Power is spread out. Many weaker leaders vs. one strong ruler or party. Susan S. . Ellenberg. , Ph.D.. University of Pennsylvania. SCT/ICTMC Joint Meeting. Liverpool, UK. May 8, 2017. CLINICAL TRIALS TIMELINE. 1948: First randomized clinical trials of modern era. 1962: Amendments to U.S. Food, Drug and Cosmetic Act requiring demonstration of efficacy as well as safety. Chris . Greacen. Palang. Thai. MEE-Net Workshop. 18 January 2012. Bangkok. Outline. What is decentralized electricity?. Centralized vs. decentralized. Practical policies for decentralized electricity. Back to the future? . Jeremy Grimshaw. Senior Scientist and . professor . Canada . Research Chair in Health Knowledge Transfer and Uptake. @. GrimshawJeremy. jgrimshaw@ohri.ca. 9. TH. MAY 2017. Foundational paper. by. Tabian Ambang. 2018. PNG Update . 14. th. of June 2018. Introduction. National Health Plan (NHP) is a key policy document for the health sector in PNG (. NDoH. , 2011).. NHP explains . PNG government’s policy directions for the health sector in PNG and priority areas for planning and service . HIV Cure Research Training Curriculum. Regulatory Issues Module by:. Damon Deming, Ph.D.. FDA Division of Antiviral Products. Nov 2014 . The HIV CURE training curriculum is a collaborative project aimed at making HIV cure research science accessible to the community and the HIV research field. . and Options for Regulators. Institute of Medicine Workshop . International Regulatory Harmonization Amid Globalization of Biomedical Research and Medical Product Development. Washington DC, February 13-14, 2013. CLINICAL TRIALS IN THE TWENTY-FIRST CENTURY: ONGOING CHALLENGES AND EMERGING ISSUES Susan S. Ellenberg , Ph.D. University of Pennsylvania SCT/ICTMC Joint Meeting Liverpool, UK May 8, 2017 CLINICAL TRIALS TIMELINE Susan S. . Ellenberg. , Ph.D.. University of Pennsylvania. SCT/ICTMC Joint Meeting. Liverpool, UK. May 8, 2017. CLINICAL TRIALS TIMELINE. 1948: First randomized clinical trials of modern era. 1962: Amendments to U.S. Food, Drug and Cosmetic Act requiring demonstration of efficacy as well as safety. Virginia A. Caine, M.D.. Associate Professor of Medicine. Division of Infectious Diseases. Indiana University School of Medicine. Director, Marion County Public Health Department. Indianapolis, Indiana.

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