PPT-ClinicalTrials.gov – How to Register Your Trial

1 ClinicalTrialsgov Operated by the National Library of Medicine NLM Your CTSA organization has an institutional account Individual investigatorsemployees are given user profiles on that account. 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. Tulane University. How Does it Affect Me?. What Do I Need to Know? . Tulane . University. . Office . of Research . Compliance. October 21, 2016. http://. www2.tulane.edu/asvpr/research-compliance.cfm. February 24, 2015. c. linicaltrials.gov. Notice of Proposed Rule Making (NPRM). November 19, 2014 - HHS published a NPRM for Clinical Trials Registration and Results Submission to clarify existing requirements for registering and submitting results and to implement the statutory requirement for expansion of the registry and results data bank.. Module 1: Clinical Trials and Requirements for Registration and Results Reporting. What is a Clinical Study?. A research study using human subjects to evaluate the effect of interventions or exposures on biomedical or health-related outcomes. [Presenter Name and contact Info]. 1. Purpose of Template Presentation. This presentation was compiled by a team from several CTSA institutions. The presentation can be modified as necessary for your individual institution. You may choose to use the presentation in its entirety or utilize individual sections as needed. . What Do I Need to Know? . Presenter Name and contact Info. Be aware that…. Any PowerPoint presentation can only be an introduction to a topic. . This subject is complex – this will point you to many other resources – and our office is happy to assist you further. . 1. ClinicalTrials.gov. Operated by the National Library of Medicine (NLM). Each . institution has an institutional account. Individual investigators/employees are given user profiles on that account. 1. ClinicalTrials.gov. Operated by the National Library of Medicine (NLM). UC Davis. has an institutional account. Individual investigators/research staff are given user access on that account. Each study gets only one record, regardless of number of sites. National network of libraries of medicine. Middle . atlantic. region. But first: housekeeping. ClinicalTrials.gov: New HHS and NIH Trial Reporting Requirements. with Becky Williams from NIH . (recorded May . 1. ClinicalTrials.gov. Operated by the National Library of Medicine (NLM). UC Davis. has an institutional account. Individual investigators/research staff are given user access on that account. Each study gets only one record, regardless of number of sites. Everything You Ever Wanted to Know About ClinicalTrials.gov (Slides for presentation only.) Deborah A. Zarin, M.D. Director, ClinicalTrials.gov May 2010 1 Background 2 What’s All The Fuss About? Suppression of research results impedes the scientific process of Medical Librarians. Network of the National Library of Medicine. Southeastern Atlantic Region. Liz Waltman / . ewaltman@hshsl.umaryland.edu. . Network of the National Library of Medicine. Trainings. Public Pressure to Enforce Final Rule. TranspariMED. /UAEM. Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study. Devito. NJ, Bacon S, . Goldacre. 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).