PPT-COVID-19 Clinical Trials Review

Committee Committee Overview amp Process for Investigators Updated as of May 18 2020 COVID19 Clinical Trials Review Committee Membership Charge Criteria for Evaluation Process Overview. 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. Protocol=study plan which details what researchers will do in the study. It describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. . 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. 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. 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 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. . This webinar is being recorded and will be posted to the CTTI website. All participants are muted upon entry. Questions can be entered in the chat box during the webinar . Questions will be . addressed after . This webinar is being recorded and will be posted to the CTTI website. All participants are muted upon entry. Questions can be entered in the chat box during the webinar. Questions will be answered to the best of our ability after the call via CTTI’s best practices document. Compensation in clinical trials can mean two distinct things:. w. hen . participants receive monetary or . other benefits.  for their participation in the clinical trial; . or. w. hen participants . 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. .