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. difficile LabID Event FacWideIN January 2013 Healthcare Personnel Influenza Vaccination All Inpatient Healthcare Personnel January 2013 Medicare Beneficiary Number All Medicare Patients Reported into NHSN July 2014 CLABSI Adult Pediatric Medical Su 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 The Bacillus thuringiensis Bt rice line which has a construct similar to the GM Shanyou 63 line was detected in some vermicelli products by identification of the junction region sequence between rice Act1 promoter and the Cry1Ac gene and that betwee RA focus 37 It’s The Law Past, Present and Future? By Kurt R. Karst In June 2006, the Food and Drug Administration (FDA) announced the publication of the agency’s final Compliance Policy 1 Unapproved Animal Drugs Initiative RDLA, . February 26, 2014. Michael J. Werner. Overarching Principles. The situation usually arises because someone is very sick and wants access to an unapproved product outside of a . clinical trial. 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?. into the World of Interactive Dashboards and . Visualizations. State Reporting. Cortni Haralson. . Manager, Texas State Reporting. Analytics and Institutional . . Reporting. Outline. Introduction. Lisa Mably. lisa.a.mably.civ@mail.mil. 2. Agenda. Sustainment Reporting. Sustainment Reporting Overview. Contractor Cost Data. Future CSDR Co-Plan. Technical Data Reporting (TDR). Description. TDR Examples. 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. 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. Module 2: Descriptive Statistics. Statistics is all about data. Without data to talk about or to analyze or to question, statistics would not exist. There is a story to be uncovered behind all data—a story that has characters, plots, and problems. The questions or problems addressed by the data and their story can be disappointing, exciting, or just plain ordinary. This module is about stories that begin with data..