PPT-Investigator Responsibilities for Research

Jan Zolkower MSHL CIP CCRP January 13 2012 Review Investigator Responsibilities Discuss recent FDA Warning letters and OHRP Determination letters Review of Advanced Notice of Proposed Rulemaking ANPRM. Jan Zolkower, MSHL, CIP, CCRP. January 13, 2012. Review Investigator Responsibilities. Discuss recent FDA Warning letters and OHRP Determination letters. Review of Advanced Notice of Proposed Rulemaking (ANPRM).  . THE BEGINNING. I am happy to answer any questions you may have now or after you get home. Please don’t hesitate to contact me anytime.. Dustin E. Grate, . Lic. #632. Spencer Investigations. 1325 . Ethics and Conflict of Interest—NIH Rules. Title IX Sexual Harassment. New Intellectual Property Assignment Procedures. ETHICS AND CONFLICT OF INTEREST CHANGES AND NEW PHS-NIH RULES. Montana State University. 2011 Revised Regulation. FCOI Webinar for Grantees. Provided by the National Institutes of Health. November 30, 2011. Financial Conflict of Interest (FCOI) 2011 Revised Regulation. Training. NEW MEXICO. . THE UNIVERSITY . of. Office of Research & . Compliance. http://researchcompliance.unm.edu. /. (505) 277-1045. coiresearch@unm.edu. What is a Conflict of Interest. ?. A situation associated with an investigator’s participation in UNM research where it reasonably appears, on an actual or potential basis:. End of Year Report. Why was the request made:. Bent, Crowley, and Huerfano Counties do not have the expertise or resources to adequately investigate member fraud and settle these cases through repayment agreements or criminal/civil court. . Director of the Endocrinology Research Laboratory, Beth Israel Medical Center, New York City 2002-2007 Assistant Professor of Medicine, Albert Einstein College of Medicine, New York City 2007-present EDISON NJ 08837 MTFBIOLOGICSORG A NON-PROFIT ORGANIZATION Equal Opportunity Employer Request for Proposals - 2021 Extramural Research GrantMTF Biologics offers research grants to fund novel --- Based on ICH . E6. GCP Guidance (. Sections1.24. &. 6) . and 45 . CFR. 46: Protection of Human Subjects . Purpose:. To . provide an overview of Investigator Responsibilities and GCP. to study sites. Kathleen O’Malley RN, BSN, CCRP. Manager of Education and Training. Jefferson Clinical Research Institute. Kathleen.omalley@jefferson.edu. Stephen . Klasko. , MD, MBA. President and CEO of TJU AND Jefferson Health System. What Every Investigator. (and his/her research staff). Should Know about. Conducting. Human Research Activities. *. Based on David Lettermen’s Top Ten . PI Responsibility #1. In designing the study, the investigator should take into consideration the three underlying ethical principles for conducting research with human subjects as delineated in the. 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. 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.