¶ … Quality Standards
Data Quality Standards
This paper examines the different ways of assessing the quality of clinical trial data submitted for regulatory purposes compared to data submitted for academic publication.
Researchers and pharmaceutical firms do clinical trials for the purposes of collecting data and sharing with industry, scholars and regulators to help make policies and decisions about the efficacy/safety of illness, disease or preventative drugs being studied. To make sure that researchers are adhering to protocol and best practices in their investigations, sponsors of such studies often monitor these trials in one way or the other (Quality Management in Clinical Trials, n.d). The main objectives of monitoring are to guarantee patient safety and the integrity of the collected data. Monitoring could entail spontaneous visits during the study so as to check on the progress.
One of the most important documents in clinical trials is the CSR (Clinical Study Report). This document contains a summary of all important information related to the study. The CSR contains: researcher information, the research design, sample case report forms, statistical analyses, tables, publications and other data related to the issue being investigated. The CSR is presented to regulators...
Quality Improvement in Healthcare Nearly all healthcare organizations today are aware of the Quality Improvement (QI) movement and seek to actively instill their businesses with such elements. In fact, the past few decades have shown the QI movement to be the main approach for healthcare organizations to measure performance and engage in lasting changes (Colton, 2000). The foundations of QI reside with its origins which come from multiple arenas: "in systems
Quality Management Different Systems, Philosophies and Approaches to Excellence Quality Management: Different Systems, Philosophies and Approaches to Excellence As is known within the field, operations management is an area of management specifically concerned with the overseeing, designing, and redesigning of business operations in the production of good and services. In order for operations to move smoothly within a business, management must ensure that day-to-day business moves forward in a manner that not only utilizes
One of the best examples of the use of statistical quality control in clerical operations is found in Aldens' Mail Order House in Chicago. Statistical quality control was begun at Aldens' early in 1945 by the installation of sample inspection and the control chart in one of the order-picking departments (Mercer, 2003). Within two months, the error ratio in this department fell from 3% to less than 1% while
Data Warehousing: A Strategic Weapon of an Organization. Within Chapter One, an introduction to the study will be provided. Initially, the overall aims of the research proposal will be discussed. This will be followed by a presentation of the overall objectives of the study will be delineated. After this, the significance of the research will be discussed, including a justification and rationale for the investigation. The aims of the study are to
However, there are certain aspects regarding quality that the company can improve. The objective of Costco is to improve quality of products and services while reducing their price. This is a difficult objective to reach, given the fact that high quality is usually attributed to higher prices. Therefore, Costco understands that it must work on technological aspects in order to improve the quality of its process and maintaining its cost
Quality in the Clinical Microbiology Laboratory The objective of this study is to define quality in the microbiology clinical laboratory including its major components. Toward's this end, this study will examine what constitutes quality in the laboratory setting and will list and discuss the activities in the laboratory that are designed to assure quality from collection of specimen to reporting. Quality management in the clinical microbiology field was initiated in the decade
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