PPT-NIH’S Redefinition of Clinical Trials and Using the New Human Subjects Form

Chris Sylvester MA Senior Grant Administrator AO Grants and Contracts 6174142879 christophersylvesterbmcorg A research study in which one or more human subjects are prospectively assigned . June 26, 2014. .. ClinicalTrials.gov and FDAAA for NIH Grantees. David Curren. Special Assistant to the Office Director. Officer of Policy for Extramural Research Administration . Objectives for This Section. 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. . How Do Changing NIH Policies Impact Me?. LCOM Informational Sessions. Nov. 14, 16 2017. Jeralyn Haraldsen, PhD. Grant Proposal Manager . Office of the Vice President for Research. Introductions:. Research Protections Office. Preview of coming changes. Form pre-implementation preview - April 27, 2017. 1. Disclaimer. This resource is:. A representation of the data items collected in the new PHS Human Subjects and Clinical Trials Information form. 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. Manager. Tufts CTSI. Welcome and Introduction. Tufts CTSI’s Mission & . Purpose. Stimulate and expedite innovative clinical and translational research, with the goal of improving the public’s health. Cynthia Monahan, MBA, . CIP. CRC . IRB Director. Karla . Damus. , PhD, MSPH, MN, RN, FAAN. Clinical Research Regulatory and Education Manager Administrator, BMC/BUMC ClinicalTrials.gov . NIH Policies. “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 No policies existed to make sure that the public had access to results from unpublished NIH-funded research . Subjects. Freda E. Yoder. Division of Education and Development. Office for Human Research Protections (OHRP). Department of Health and Human Services (HHS). Ann M Hardy, Dr.P.H.. NIH Extramural Human Research Protection Officer. Great Plains . IDeA. -CTR Network. February 12, 2018. Bethany DeCarolis, CRA, Assistant Director. Sponsored Programs Administration. Agenda. “FORMS-E. ” application requirement. Selecting . the correct funding opportunity. 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 . JHU-TUFTS Trial Innovation Center (TIC). JAMA October 4, 2016 Volume 316. Number 13, 1353. NIH Stewardship & “…the new era.”. Fundamental Policy Changes. ICs are developing clinical-trial specific FOAs with new requirements for clinical trials.