PPT-Development of a study protocol in osteopathic clinical res

a Kaiser A 1 Heard J 2 Resch KL 3 Schwerla F 4 1 Osteopathic practice Germany 2 Postgraduate School of Osteopathic Clinical Research A T Still University USA . AMWA Northern California Chapter . 04 Oct 2014. 10/4/2014. 1. Topics. Relevant definitions, background. Protocol audiences. Purposes of protocols. Protocol components. Per ICH . E6 . Additional (synopsis, glossary, appendices). in . Geriatrics. Michael F. . Oliverio. , D.O., C-FP, C-NMM-OMM. References. Foundations of Osteopathic Medicine 2nd Ed. p.230-231, 327-337 . Foundations of Osteopathic Medicine 3rd Ed. p.873-882. “Them Old Bones” The Osteopathic Approach to the Older Population. “The Immersion”. Lawrence M. Witmer, PhD. Professor of Anatomy. Dept of Biomedical Sciences. Heritage College . of Osteopathic . Medicine, Ohio . University. Athens, Ohio 45701. witmerL@ohio.edu. Frances Richmond . Director International Center for Clinical Trials. And you are…. The principal investigator of a company-sponsored trial?. The principal investigator of an investigator-sponsored trial?. CONFIDENTIAL Page 8 of RTCy ruxolitinib 33Acute graft-versus-host disease treatment 33Dose regimen and modification 34Drug supplies 35Other study treatments 35Concomitant medications 35Permitte protocol. Outline . Identify the session objective. Discuss the content of a clinical trial protocol. Discuss the content of observational study. Conclusion . Study objective. Participants will learn about the essential elements of a clinical trial protocol. Week 3- Proposing and Conducting a Clinical Trial. J. Kaitlin Morrison, PhD. Director of UNC Lineberger Sponsored Clinical Research. Assistant Professor of Medicine- Hematology . Kaitlin_Morrison@med.unc.edu. . and . LeeAnna. Bowman-Carpio . CTSI Grants Submission Unit (GSU). Clinical and Translational Science Institute. Practical Approaches to NIH’s New Human Subjects and Clinical Trials Updates. www.ctsi.ucla.edu . Derita: . dbran@uthsc.edu. Margaret: . mlynn@uthsc.edu. https://tnctsi.uthsc.edu/training-and-education/seminars-and-workshops/tn-ctsi-certification-exam-preparation-course/. Handout/Reference sheets:. . HVTN satellite. 21. st. July 2019. HIV Vaccine efficacy studies . and the MOSAICO clinical trial. Disclosure. I have . the following conflicts of interest to declare: . I am an employee of Janssen Vaccines & Prevention B.V., a pharmaceutical company of Johnson & Johnson. 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. Conducting a Clinical Trial. Wendy M Kohrt, PhD. Nancy Anschutz Chair in Women’s Health Research. Distinguished Professor of Medicine, Division of Geriatric Medicine. University of Colorado – Anschutz Medical Campus. SESSION 8. Handout/Reference sheets:. Study Start-up. NIH guideline-study-start-up document. Study start-up Tips. SOP reference sheet from Session 9. Webinars:. Research 101, session 4. Research 102, session 4. SESSION 8. Handout/Reference sheets:. Study Start-up. NIH guideline-study-start-up document. Study start-up Tips. SOP reference sheet from Session 9. Webinars:. Research 101, session 4. Research 102, session 4.