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Slide 1 Knowledge Update Clinical documentation: from preclinical studies to drug registration Split, 12 September 2008 Slide 2 Overview of drug development Company Drug…
Slide 1 Tool: Sponsor Responsibilities Based on ICH E6 GCP Guidance (Section 5) Purpose:To provide an overview of Sponsor Responsibilities to study sites Audience/User:NIDCR…
Slide 1 Analysis Issues in Assessing Efficacy in Randomized Clinical Trials “Intention to Treat” and Compliance Elizabeth Garrett-Mayer Oncology Biostatistics April 26,…
Slide 1 Statistical Aspects of Correlative Studies Slightly modified version based on talk by: Meredith M. Regan, ScD Dept. Biostatistics and Computational Biology Dana-Farber…
Slide 1 HSP progress in Taiwan 2009 Benjamin I. Kuo, MD, DrPH, CIP Secretariat, Joint Institutional Review Board Slide 2 Laws and regulations applied to researches in Taiwan…
Slide 1 Ethics Committees Caterina Moniz Vaz Slide 2 (Bio)ethic Comittee Possible definitions: an interdisciplinary group of people, constituted by health professionals and…