PPT-Tool: Training Presentation: Clinical Research Responsibilities for NIDCR-Funded Investigators

Purpose To provide an overview of the key roles and responsibilities of investigators and staff engaged in NIDCRfunded research AudienceUser NIDCR study staff including PIs SubIs and Site Study Coordinators. fdagovScienceResearchSpecialTopicsRunningClinicalTrialsGuidancesInformationSh eetsandNoticesdefaulthtm US Department of Health and Human Services Food and Drug Administration June 2010 Procedural brPage 2br Contains Nonbinding Recommendations Informa HASWIRA NOR MOHAMAD HASHIM. PhD . CANDIDATE. LAW AND JUSTICE RESEARCH CENTRE. QUEENSLAND UNIVERSITY OF TECHNOLOGY. GARDENS POINT CAMPUS. BISO-BRDI-CFRS. . INTERNATIONAL SYMPOSIUM 2011. On the Case for International Sharing of Scientific Data: . of the . Clinical Research . Team. Kathleen O’Malley RN, BSN, CCRP. Manager of Education and Training. Jefferson Clinical Research Institute. Kathleen.omalley@jefferson.edu. Learning Objectives:. Name the required and possible members of the research team. IMIGASTRIC. I. nternational study group on . M. inimally . I. nvasive surgery for . G. astri. c . C. ancer. Project Manager: Amilcare Parisi. Department . of General Surgery, . Jinling. Hospital, Medical School, Nanjing University. Nanjing, . Tom McAllister. Office of Procurement and Assistance Management . COR-Integral Member of the Federal Acquisition Work Force. . OFPP Memo--. Revisions to the Federal Acquisition Certification for Contracting Officer’s Representatives (FAC-COR). Tool:. Clinical Monitoring Overview Training Slides. Purpose:. To. let study staff know what to expect during a monitoring visit. Audience/User:. NIDCR. study staff, including PIs, Sub-Is, and Site Study Coordinators. Overview of Good Clinical Practices (GCP) . Investigator and Study Team Responsibilities. Miles McFann. IRB Administration. Training and Outreach. 2. Good Clinical Practice is the compilation of accepted ethical and scientific standards governing clinical research that ensure the integrity of data obtained and the protection of human research subjects.. Tool:. Clinical Monitoring Overview Training Slides. Purpose:. To. let study staff know what to expect during a monitoring visit. Audience/User:. NIDCR. study staff, including PIs, Sub-Is, and Site Study Coordinators. John Naim, PhD. Director. Clinical Trials Research Unit. West Virginia University. March 20, 2015. West Virginia Clinical and Translational Science Institute. Outline . Historical Perspective. Legal Framework. Lauren Sterling. Managing Director, . UCSF-Gladstone . Center for AIDS . Research (NIH P30 AI027763). (No Conflicts of Interest to disclose). CFAR Mission. To support a multidisciplinary, collaborative environment that promotes basic, clinical, behavioral, and translational research in the prevention, detection, and treatment of HIV infection and AIDS. TN-CTSI. Derita Bran, BSN, RN, CCRC. Molly Rolen, BSN, RN, CCRP. Research Reflection series co-sponsored by . TN-CTSI and UTHSC Office of Research Development. 1. Disclaimer. This is a general slide presentation and should not be considered all- inclusive of a researcher’s responsibilities. Investigator of Record – Definition. “The individual at the CRS responsible for ensuring that a clinical trial is conducted in accordance with the protocol, applicable U.S. federal regulations, in-country regulations and any provisions imposed by the reviewing IRB/EC/other regulatory entity. This person is the signatory for the Form FDA 1572 for studies conducted under an IND or the DAIDS Investigator of Record Form for non-IND studies.” (from DAIDS Protocol Registration Manual, p.8). Presented by the . Research Quality Compliance Network.  . PRESENTERS. Ginger Bair, CCRP – QA/QC Coordinator, Office of Quality Compliance and CTSI. Josh Fessel, MD, PhD . –. . Senior Clinical Advisor, Division of Clinical Innovation, NCATS and NIH. Jim McCarthy; Rutz. , . Erich; . W. ade Shrader; . E. rich Rutz; . Tom . Novacheck; . Kerr . Graham; . Davids, Jon R. .; . Kay, . Robert; Tim Theologis; Unni Narayanan; Anja . Van . Campenhout. ; Laura Brower; Paul Gross.