PPT-Centralizing the Clinical Trial Registration and Results Reporting Process in Academic

Tony Durkee PhD Coordinator for Clinical Trial Reporting Compliance amp Data Office CDO Research Support Office RSO Karolinska Institutet KI Email tonydurkeekise 6172021 Tony Durkee. Anh Ninh, College of William and Mary. Outline. Introduction. The Inventory Positioning Problem. Description of the problem. Unique features. Basic of inventory management. Site Selection Problem. 2. The Balance from . A Medical Communicator’s Perspective. 6th Asia-Pacific . Pharma. Congress. July 11-13, 2016 Kuala Lumpur, Malaysia. Dr.Namrata. Singh. Director - Medical Services. Turcaoz. Health Care Solutions. CONTENTS. REGISTRATION. . THE FLOW . 04. ACADEMIC SESSION CREATION. 05. DAY/TIME ASSIGNMENTS . 06. REGISTRATION AUTHORIZATION . 07. REGISTRATION HOLDS . 08. MAX/EXCESSIVE HOURS. 09. MyUI. NEW USER REGISTRATION NEW USER REGISTRATION Completing New User Registration activates your profile! Users only need to complete this process once. Let’s get started… NEW USER REGISTRATION Under GLOBAL SIGN IN, Click “CalATERS Global” 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 MSME Registration or SSI Registration is mandatory for small business entities. It will help them in availing subsidies, incentives, concessional rate loans and other registration benefits offered by the government. The eligibility criteria to obtain the Online MSME Registration certificate differs on the basis of the investment in plant and machinery. Best Practices and Enhanced Standards for Research. “International norms, standards, and guidelines … are required to govern, manage and improve the quality of research; address inefficiencies…; promote transparency (related to planned, ongoing, . Unblinding. and Termination. Within-trial . decisions . are decisions that need to be made once a . clinical trial.  has already . started, . for example, if there is an . unexpected . problem. . These . T. he . trial sponsor . compiles . a detailed clinical study report (CSR. ) after each clinical trial. . This report follows . a format laid down by the regulatory . authorities.. The CSR can be hundreds of pages long.. “Putting it All Together. ”. 1. Why the changes to NIH-funded studies involving human subjects?. No policies existed to make sure that the public had access to results from unpublished NIH-funded research . Clinical trials . are required in the development of . new . medicines and improved treatments . for . patients. . The . information that clinical trials generate on the efficacy and safety of . treatments . For . Clinical Researchers. Objectives:. Provide an overview of protocol registration mandates for clinical researchers. Introduce ClinicalTrials.gov and the Protocol Registration and Results System (PRS). Karen-Sue Carlson, MD, PhD. Associate Professor of Medicine. Division of Hematology and Oncology. Section Head and Medical Director of Acute Care. Medical College of Wisconsin. Milwaukee, WI. What are clinical trials?. PERFUSE Medical Research &. Clinical Trial Course. Clara Fitzgerald, MPH. The Importance of Clinical Trial Protocols. The Clinical Trial Protocol is the complete written description of, and scientific rational for clinical research studies.