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x0000x0000Clinical Investigator Training Coursex0000x0000Clinical Investigator Training Coursex0000x0000Clinical Investigator Training Coursex0000x00008xMCIxD 0 xMCIxD 0 but the diagnosis of so. 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). Shannon Simmons, BA, CIP. March 14, 2014. Process Improvement Team. Vanderbilt Human Research Protections Program. Agenda. Review Investigator Responsibilities. Discuss FDA Warning letters . Q & A. 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. 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. 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). Investigator Safety. Instructor Name. Agency. Session Introduction. Learning Objectives. Upon completion of the session, you will be able to: . Describe security and safety concerns faced by investigative staff and ways they may be reduced.. 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. GCP: . Tips on Clinical Trial Conduct and . Preparing for FDA Inspection . Susan Leibenhaut, M.D.. Office of Scientific Investigations (OSI) . CDER/FDA. February 28, 2019. Good Clinical Practice - GCP. GICA 20 20 In - Person and Webinar Training Title IX – Investigator Training – Part IV (1 Hour In - Person , Webinar , and Videotaped - August 2020 ) AGENDA Title IX Investigator Training GICA 2020In-Person and Webinar TrainingTitle IX Investigator Training Part IV1 Hour In-PersonWebinar and Videotaped -August 2020AGENDATitle IX Investigator Training Part IV ANSI/ASIS INV1-2015 Investi GICA 2020In-Person and Webinar TrainingTitle IX Investigator Training Part IV1 Hour In-PersonWebinar and Videotaped -August 2020AGENDATitle IX Investigator Training Part IV ANSI/ASIS INV1-2015 Investi 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. \"6 minutes ago -

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