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 . 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. This guidance represents OHRP's current thinking on this topic and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word should in OHRP guidance Objectives This presentation will address the following issues: •What events must be promptly reported to the Quorum Review institutional review board •When and how such events must be repor Communicating Unanticipated Adverse Outcomes — Implementation Guidelines — October 2002 Developed and Distributed by KFHP/HP and The Permanente Federation, LLC Communicating With Pati SOP KP-502. Research Compliance Training. 2012. KPSC . IRB Version 2-1 . Dated . 8/27/2015. Required Training. . The training takes approximately 1 hour.. All Research Team Members who contribute to the conduct of research must complete the training, including:. 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. . Melody Lin, Ph.D.. December,12. 2012. Unanticipated problems involving risk to participants or others. Is . unexpected . Is . related or possibly related . to participation in the research, and. Indicates that subjects or others are at a . 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 . . Professor Burton. Fall 2016. November 1, 2016. Second Mid-Term Coming Up. Thursday, November 10. th. Will cover CAPM and APT (as well as . everything else . in class, . powerpoints. , readings). November 1, 2016. Unanticipated inflation – some people are hurt; some people gain. . For example, borrowers are helped by unanticipated inflation while lenders are hurt. . However, even anticipated inflation results in costs for the economy.. 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. 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. 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)(.