PPT-Unanticipated Problems

15 th FERCAP International Conference 24 Nov 15 Nagasaki Japan Bussara Sukpanichnant CIP USAMDAFRIMS 1 Why I need to know about Unanticipated Problems Unanticipated Problem Involving Risks . J Henderson M T Popat I P Latto and A C Pearce 1 Anaesthetic Department Gartnavel General Hospital 1053 Great Western Road Glasgow G12 0YN UK 2 Nuf64257eld Department of Anaesthetics John Radcliffe Hospital Headington Oxford OX3 9 DU UK 3 Anaestheti Sonofabitch Charlie said wiping the metal detector on his shirt It was supposed to be waterproof but it had cost him almost 300 bucks not a small sum for an old man who had to make do with his crappy Social Security allotment and who paid for his he Which Form 4 to Use?. Reason for Reporting Unanticipated Problems. “to assure the protection of the rights and welfare of the human subjects”. UTHSC IRB Submission Forms. 4a: Reportable local adverse events. , Unanticipated . Problems, and Protocol Deviations. Kathleen O’Malley RN, BSN, CCRP. Manager of Education and Training. Jefferson Clinical Research Institute. Kathleen.omalley@jefferson.edu. 1. Learning Objectives: Adverse Events. An IRB . infoshort. for . IRB Members. October 2013. Unanticipated . Problems Involving Risks to Subjects or . Others . (UPIRSO) . versus . Serious Adverse Events (SAEs). GOALS. AAHRPP site-visit observation . Plant Tours In addition, unanticipated production needs may necessitate the cancellation of a tour. TMMC requests that all groups booking tours understand and accept the possibility of tour cancellati Madison County School System. July 1, 2012-present. About Madison County. Rural, agricultural, blue-collar community. 155 out of 180 in terms of property wealth, a low wealth district. 67% free and reduced lunch. Anticipated and. Unanticipated Changes. Understanding Macroeconomics. —. Our Game Plan. Anticipated changes . are fully expected . by . economic participants. . Decision makers have time to adjust to . 15. th. FERCAP International Conference. 24 Nov 15. Nagasaki, Japan . Bussara Sukpanichnant, CIP. USAMD-AFRIMS. 1. Why I need to know about Unanticipated Problems?. Unanticipated Problem Involving Risks . Anticipated and. Unanticipated Changes. Understanding Macroeconomics. -- Our Game Plan. Anticipated changes . are fully expected . by . economic participants. . Decision makers have time to adjust to . Lesson Objective: 4.01a. Students will know how to solve word problems using slope. Slope Word Problems. In 2005, Joe planted a tree that was 3 feet tall. In 2010, the tree was 13 feet tall. Assuming the growth of the tree is linear. Office of Research Oversight Reporting: Who, What, When, and Why February, 2012 CASE #1- A Serious Adverse Event The Background: A PI became aware of a local unanticipated serious adverse event on January 1, 2012. It was not reported to the IRB by the PI until January 25, 2012, as part of a continuing review submission. Human Research Protection Program (HRPP). HRPP COMPLIANCE AND QUALITY TEAM . Yale University. . Federal regulations (45 CFR 46 & 21 CFR 56) require institutions to establish written procedures for ensuring prompt reporting of any unanticipated problems involving risks to subjects or others (UPIRSOs) to the IRB, appropriate institutional officials, and the federal department or agency head.. UVM Research Protections Office. Unanticipated Problems (UAPs). The IRB is responsible per federal guidelines to review any unanticipated problems involving risks to subjects or others occurring in approved research (FDA: 21 CFR 56.108 (b)(1) & DHHS: 45 CFR 46.103(b)(5)(.