PPT-ClinicalTrials.gov Registration & Reporting Requirements

University of Maryland School of Nursing Noon Lecture February 12 2019 Presented by Anthony Keyes MBA PMP Director Aliya Lalji MD Clinical Research Compliance Specialist. difficile LabID Event FacWideIN January 2013 Healthcare Personnel Influenza Vaccination All Inpatient Healthcare Personnel January 2013 Medicare Beneficiary Number All Medicare Patients Reported into NHSN July 2014 CLABSI Adult Pediatric Medical Su 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. 1. ClinicalTrials.gov. Operated by the National Library of Medicine (NLM). Your CTSA organization. . has an institutional account. Individual investigators/employees are given user profiles on that account. 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 . 3: The Librarian’s . Role in Advocating to Clinical Researchers. Increased Requirements for Registration and Results Reporting. Selective publication makes . it difficult to determine the true value of a . [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. 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).