PDF-Reporting Unapproved Deviations in PHRC

Rev 9242014 Title Approved Research Department Human Research Affairs Policy Type xF0FE Partners System wide xF0A8 Partners System wide Template xF0A8 Partners HealthCare xF0A. If there is a deviation from the approved protocol an initial report should be made to the Director within no more than one week 7 calendar days of the Principal Investigator learning of the incident The report can be made via eProtocol on a Protoco Essential tools for large deviations analysis weak convergence of probability measures Section 3 and relative entropy Section 4 Weak convergence especially useful in the Dupuis and Ellis 1997 approach see lectures Table 1 Notation a topological spa Thurs. Fri. Sat. Sun. Mon. Tues. Wed. 9am:. Employee weekly submission reminder. 5pm. : . Employee. weekly time reporting deadline. 5pm: . 1. st. Unreported time notification to employees . 10am: . , 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. Some Review and Some New Ideas. Remember the concepts of variance and the standard deviation…. Variance is the square of the standard deviation. Standard deviation (s) - the square root of the sum of the squared deviations from the mean divided by the number of cases. . Gary Boyd. Deviations in worship of the church. Building the foundation….. We are constantly bombarded with information…sometimes we must make decisions with this information.. What is the basis of our decision making?. RISK FACTORS. HISTORY. WHAT IS BEING DONE. FAA. DOD. IMPACT. WHO PAYS. COUNTERFEIT PARTS. . What is a counterfeit part?. Some examples:. Type of Unapproved part. Deliberately misrepresented as FAA approved. Kevin McLeod & Chris Horton. OCE, Region 12 Houston. 1. Introduction. Brief discussion of history and scope. Review of compliance documents. Investigation process. 2. Clean Air Act. 1977 Clean Air Act. Annette Maxwell and Erica Solis. Office of Compliance and Enforcement . May 5, 2015. Brief discussion of history and scope. Review of compliance documents. Investigation process. Introduction. 1977 Clean Air Act. What do I do now?. Identifying and Reporting . Adverse Events and Protocol Deviations. Elizabeth Mathis, CCRP. 18 February 2014. Overview and Objectives. http://www.hhs.gov/ohrp/policy/advevntguid.html. Human Research Protection Program (HRPP). HRPP COMPLIANCE AND QUALITY team . Yale University. Agenda. Who is the . HRPP Compliance and Quality Team. Deviations . Best Practices to prevent deviations. Frequently Asked Questions Regarding the Department of Health and Human Services146 Announcement on the Unapproved Drugs InitiativeQ What action is the Department taking todayA Through a Notice publis 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. Jeri Barney, JD, MS, CIP, Senior Compliance Manager. Jess Randall, MA, CIP, Compliance manager. Human Research Protection Program (HRPP). Research Quality Assurance & Compliance (RQA&C). Yale University.