PDF-Investigator Initiated Research:Risks, Responsibilities, and RewardsIn

Lori T Gilmartin BUMC GCRC RSA Support Research Consultant A Growing ConcernA Growing Concern PhRMArecently reported that spending on IIR had increased by 20 IIR spending is rising faster than on. Investigator-Initiated . v. Sponsor-Initiated Clinical Trials – What are the special contract and administration issues to be aware of?  . NCURA Western Regional Conference April 5, 2011 – Denver, CO. 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 . 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. 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. Stephen Workman, MPH. September 2016. Thomas Jefferson University. Investigator responsibilities. Sponsor assessment of PI performance . What TJU does well. How PIs can be more impressive to sponsors. 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. 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. . x0000x0000Clinical Investigator Training Coursex0000x0000Clinical Investigator Training Coursex0000x0000Clinical Investigator Training Coursex0000x00008x/MCIxD 0 x/MCIxD 0 --- but the diagnosis of so Derita: . dbran@uthsc.edu. Margaret: . mlynn@uthsc.edu. https://tnctsi.uthsc.edu/training-and-education/seminars-and-workshops/tn-ctsi-certification-exam-preparation-course/. Handout/. Reference sheets:. Purpose:. To . provide an overview of the . key roles and responsibilities of investigators and staff engaged in NIDCR-funded research. . Audience/User:. NIDCR. study staff, including PIs, Sub-Is, and Site Study Coordinators.