PPT-Designing efficient processes for TMF Content when outsourcing clinical trials

Designing efficient processes for TMF Content when outsourcing clinical trials Lisa Mulcahy Lisa Mulcahy has a 23year professional career in the Pharmaceutical Research industry Content and Records Management independent consultant. Cynthia M. Otto, DVM, PhD DACVECC. Associate Professor of Critical Care. What is a clinical trial?. A prospective evaluation in which the factor of interest is controlled by the investigator. RANDOMIZATION. . Liz Philpots, head of research, AMRC. Summary. About me & AMRC. About the EU Clinical Trials Regulation – what’s new. Implementation timeline. What does this mean for UK ethicists?. AMRC established 1987. 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. Towards EDCTP2. 22 July 2014. Melbourne, Australia. Ole F. Olesen, Ph.D., HD. Director of North-North Cooperation,. EDCTP, The Netherlands. Justification for EDCTP2. Objectives. C. linical . development of effective, safe, accessible, suitable and affordable medical interventions for poverty related and neglected . 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 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. Module 3: The Basics of Health Care. Oncology Patient Navigator Training: The Fundamentals. Acknowledgements. This work was supported by Cooperative Agreement #1U38DP004972-02 from the Centers for Disease Control and Prevention. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the Centers for Disease Control and Prevention.. Ashley E. Ross MD PhD. Executive Medical Director. Mary Crowley Cancer Research Centers. NASPCC Annual Meeting 2019. Objectives. Define GCP (Good Clinical Practice) and its applications for patients and research.. History, Current Regulations , and Future Considerations by Kalindi Naik Project Submitted to the School of Health Sciences Eastern Michigan University in partial fulfillment of the requirements for Professor Julia . Brown. Leeds Institute of Clinical Trials Research, University of Leeds. Introduction. First clinical trial in 1747, James Lind. Clinical trials are gold standard for the evaluation of new treatments/interventions in health care . By: Caitlin Vinyard. HSC Sponsored Projects Office. What is a Clinical Trial?. Clinical trials . or Clinical Study are defined in concurrence with NIH and Office of Human Protections (HRPO) guidelines. . Helen Hill. Senior Regional Advisor Clinical Trials . hhill. @liv.ac.uk. www.ctrc.org.uk. . Specialist. . units . to . design, conduct, analyse and publish clinical trials and other well-designed studies. . Covered in this presentation. Basic information about clinical trials. Information about finding a clinical trial. Information about participating in or leaving a clinical trial . Vision. Mission. Make Ontario a preferred location for global clinical trials, while maintaining the highest ethical standards.. INTRODUCTION. TYPES. PHASES OF CLINICAL TRIALS. DESIGN OF CLINICAL TRIALS. CONTENTS. Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes..