PPT-Responsibilities of the Principal Investigator

Anne Roussell RN adapted from MAGI Complion Presentation by Velma Marzinotto RN April 2018 1 References ICH E6 R2 Good Clini c al P r ac t i c es G. Hopefully everyone has settled into new ro utines and rhythms as we transition into autumn Pl ease join us in welcoming our newest Eagle staff members Jacqueline Damon G8 Science Humanities Jennifer Jones G6 Science Humanities Melina Dyer Mathemat Over the p ast two months I have had the opportunity to meet staff students and parents to accelerate my acclimation process D uring this time it has been fantastic to see Shahala through the eyes of those who learn and work here each and every day 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 . 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). Jeffrey M. Cohen, Ph.D. CIP. Chief Executive Officer. HRP Consulting Group. Overview. History. Human Research Protection Program. Investigator Responsibilities. 2. © HRP Consulting Group. History. 3. 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. 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. 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. . 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.. PROJECT SUMMARY (See instructions): RELEVANCE (See instructions): Project/Performance Site Primary Location Organizational Name: DUNS: Street 1: Street 2: City: County: State: Province: Country: Zip/P x0000x0000Clinical Investigator Training Coursex0000x0000Clinical Investigator Training Coursex0000x0000Clinical Investigator Training Coursex0000x00008x/MCIxD 0 x/MCIxD 0 --- but the diagnosis of so 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.