The International Council for Harmonisation (ICH) E6(R2) (International Council for Harmonisation (ICH). ICH harmonised guideline: integrated addendum to ICH E6(R1): guideline for good clinical ...practice E6(R2). 2016.
https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
. Accessed 5 Dec 2019) introduced Quality Tolerance Limits (QTLs) to the industry, and in doing so, modernized quality control for clinical trials. QTLs provide measured feedback on clinical trial parameters previously only used by statistical and clinical functions to track trial progress toward endpoints. Elevating these measures as part of the Quality Management System (QMS) provides greater visibility across clinical trial functions and the enterprise as well as to measures that are important indicators of the state of participant protection and reliability of trial results. In support of this new requirement, TransCelerate developed a framework to guide industry sponsors and their agents in implementing QTLs. This QTL Framework is intended to aid industry’s ability to improve the quality of clinical research through the implementation of QTLs in a way that helps protect trial participants and reliability of trial results while meeting Health Authority (HA) expectations. The framework is intended to maximize efficiency and minimize confusion in the implementation of QTLs. The framework includes proposed approaches for implementation of QTLs for a clinical trial as defined in Section 5.0.4 and 5.0.7 of ICH E6(R2) (International Council for Harmonisation (ICH). ICH harmonised guideline: integrated addendum to ICH E6(R1): guideline for good clinical practice E6(R2). 2016.
https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
. Accessed 5 Dec 2019) and considerations for setting thresholds.
Este estudio propone un modelo de gestión de riesgos, basado en la norma ISO 31000:2012 para el área de docencia de pregrado. La gestión integral del riesgo es un componente estratégico esencial que ...permite establecer los puntos de control para evitar incumplimientos de los objetivos de la organización. El modelo propuesto permite apoyar los procesos de acreditación a través de indicadores orientados a mejorar la eficiencia de los procesos docentes. Para esto, el modelo genera matrices de riesgo y establece Indicadores Claves de Riesgo (KRI). La aplicación del modelo se realiza en la Universidad Católica del Norte (UCN) en Chile, la cual cuenta con sedes en Antofagasta y Coquimbo en las que se imparten 35 carreras. Los resultados obtenidos permitieron definir riesgos inherentes y residuales en los procesos docentes y el establecimiento de controles sobre los procesos críticos.
During 1999 and 2001 re-excavations in Križna jama were carried out, which brought crucial results concerning the taxonomical and stratigraphical position of the fossil taphocoenosis, especially of ...cave bears, and on their ethology. Moreover new data on the hydrological structure of the cave as well as on its sedimentology were published. A substantial part of this volume is dedicated to the extant fauna of this cave, which is extraordinary rich in species.
The banking industry is one of the most important industries in developing countries, thus it plays a major role in the financial industry. Moreover, e-banking has simplified financial transactions. ...This study investigates the effect of individual factors on user behaviour and the moderating effect of attitude on the relationship between individual factors and user behaviour based on the Unified Theory of Acceptance and Use of Technology. A model suggests a second-order components research framework that improves current explanations of electronic banking channel services acceptance and sheds light on the role of attitude on the acceptance of electronic banking channel services which is the most important key concern. Data were collected using an online questionnaire with 476 valid responses from academic staff who work at the University of Sulaimani; the model has been tested using the Partial Least Squares-Structural Equation Modeling approach. The results show that individual factors have a positive effect on user behaviour and also show that attitude has a negative effect on the relationship between individual factors and user behaviour as a moderator.
Clinical risk includes any undesirable situation or operational factor that may have negative consequences for patient safety or capable of causing an adverse event (AE). The AE, intentional or ...unintentionally, may be related to the human factor, that is, medical errors (MEs). Therefore, the importance of the health-care risk management is a current and relevant issue on the agenda of many public and private institutions. The objective of the management has been evolving from the identification of AE to the assessment of cost-effective and efficient measures that improve the quality control through monitoring. Consequently, the goal of this paper is to propose a Key Risk Indicator (KRI) that enhances the advancement of the health-care management system. Thus, the application of the Value at Risk (VaR) concept in combination to the Loss Distribution Approach (LDA) is proved to be a proactive tool, within the frame of balanced scorecard (BSC), in health organizations. For this purpose, the historical events recorded in the Algo-OpData
database (Algorithmics Inc., Toronto, ON, Canada, IBM, Armonk, NY, USA) have been used. The analysis highlights the importance of risk in the financials outcomes of the sector. The results of paper show the usefulness of the Clinical-VaR to identify and monitor the risk and sustainability of the implemented controls.
Continuous education is mandatory for all urologists, and undertaking cooperative research is a very effective means for this. We describe the experience and possibilities for continuing education ...for urologists in the Kurdistan region of Iraq. We hope to provide a framework for stimulating urological education and research in other countries where urologists face the same obstacles.
Data were obtained from the perspective of two academics who co-operate with urologists from Iraq, and from the perspective of two officials from the Ministry of Higher education of the Kurdistan Regional Government who are responsible for stimulating continuous education.
Based on a co-operative and supportive attitude of both Government and Academics, urologists in the Kurdistan region of Iraq have brought the standards of education and cooperative research to an internationally competitive level.
The authors hope that the examples given here can stimulate urologists from Arab countries to fully engage in new urological developments, despite the obstacles that they perceive.
E-government systems world are employed all over the world in an attempt to utilize information and communications technology (ICT) to improve government services provided to a range of stakeholders. ...In employing these systems, governments aim to become more accessible, effective, efficient, and accountable to their citizens. To improve the quality of service delivery to the public, government institutions have to cooperate and manage the shared resources and information flows. The aim of this paper is to analyse one of the established e-government stage models, such as the United Kingdom, and to identify possible opportunities to adopt them for use in the regional governments of developing countries. The study revealed that the analysed model cannot be adopted for use in the Kurdistan Region of Iraq (KRI) due to various critical issues relating to ICT infrastructure, e-readiness, legal framework, cultural attitude, education level, political process, and others.
This article examines vocabulary for taste and flavor in two neighboring but unrelated languages (Lao and Kri) spoken in Laos, southeast Asia. There are very close similarities in underlying semantic ...distinctions made in the taste/flavor domain in these two languages, not just in the set of basic tastes distinguished (sweet, salty, bitter, sour, umami or glutamate), but in a series of further basic terms for flavors, specifying texture and other sensations in the mouth apart from pure taste (e.g. starchy, dry in the mouth, minty, tingly, spicy). After presenting sets of taste/flavor vocabulary in the two languages and showing their high degree of convergence, the article discusses some methodological and theoretical issues that arise from the observation of close convergence in semantic structure across languages, in particular the issue of how much inter-speaker variation is possible not only across apparently highly convergent systems, but also within languages. The final section raises possible causes for the close convergence of semantic structure in the two languages. The conclusion is that the likely cause of this convergence is historical social contact between speech communities in the area, although the precise mode of influence (e.g. direction of transmission) is unknown.
This paper proposes a new index of Key Risk Indicators (KRI) as an effective framework for the measurement, management, and supervision of operational risks. In doing so, this paper collects thirty ...core KRI`s with unified definitions for the January 2007 - June 2010 period from six large Korean advanced measurement approach (AMA) banks. The core KRI`s are selected in such a way to account for the operational risk types categorized by Basel II and the number of assigned core KRI`s to each operational risk type is intended to mimic the observed pattern of the actual operational losses experienced by large banks during the 2004- 2009 period. The historical banking industry operational risk index (ORI) suggests a downward trend since the Lehman Brothers bankruptcy, and particularly during the first half of 2009, reflecting in part, banks` tighter implementations of operational risk management to survive through a crisis, and thereof economic recession, and in part, tighter monitoring by the supervisors as part of micro-prudential surveillance during a crisis. The empirical results indicate that 35 percent of the variation of 6-month-ahead actual loss events is explained by the current banking industry ORI suggesting its potential usefulness as an early warning system for the state of operational risks. Further, the results suggest that the individual banks` operational risks are closely related to the characteristics of their portfolios.
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