scholarly journals Data Quality Objectives for Regulatory Requirements for Dangerous Waste Sampling and Analysis

1999 ◽  
Author(s):  
C.H. MULKEY
Keyword(s):  
Data Quality ◽  
Regulatory Requirements

scholarly journals Clinical researchers’ lived experiences with data quality monitoring in clinical trials: a qualitative study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Lauren Houston ◽  
Ping Yu ◽  
Allison Martin ◽  
Yasmine Probst
Keyword(s):  
Clinical Trials ◽  
Data Quality ◽  
Good Clinical Practice ◽  
Phenomenological Approach ◽  
Education And Training ◽  
Quality Monitoring ◽  
Data Monitoring ◽  
Regulatory Requirements ◽  
Industry Standards ◽  
And Training

Abstract Background Fundamental to the success of clinical research that involves human participants is the quality of the data that is generated. To ensure data quality, clinical trials must comply with the Good Clinical Practice guideline which recommends data monitoring. To date, the guideline is broad, requires technology for enforcement, follows strict industry standards, mostly designed for drug-registration trials and based on informal consensus. It is also unknown what challenges clinical trials and researchers face in implementing data monitoring procedures. Thus, this study aimed to describe researcher experiences with data quality monitoring in clinical trials. Methods We conducted semi-structured telephone interviews following a guided-phenomenological approach. Participants were recruited from the Australian and New Zealand Clinical Trials Registry and were researchers affiliated with a listed clinical study. Each transcript was analysed with inductive thematic analysis before thematic categorisation of themes from all transcripts. Primary, secondary and subthemes were categorised according to the emerging relationships. Results Data saturation were reached after interviewing seven participants. Five primary themes, two secondary themes and 21 subthemes in relation to data quality monitoring emerged from the data. The five primary themes included: education and training, ways of working, working with technology, working with data, and working within regulatory requirements. The primary theme ‘education and training’ influenced the other four primary themes. While ‘working with technology’ influenced the ‘way of working’. All other themes had reciprocal relationships. There was no relationship reported between ‘working within regulatory requirements’ and ‘working with technology’. The researchers experienced challenges in meeting regulatory requirements, using technology and fostering working relationships for data quality monitoring. Conclusion Clinical trials implemented a variety of data quality monitoring procedures tailored to their situation and study context. Standardised frameworks that are accessible to all types of clinical trials are needed with an emphasis on education and training.

Letter to the Editor: The Continuing Challenge of Evaluating RSD Impairment and Disability

1998 ◽  
Vol 3 (5) ◽  
pp. 8-10
Author(s):  
Robert L. Knobler ◽  
Charles N. Brooks ◽  
Leon H. Ensalada ◽  
James B. Talmage ◽  
Christopher R. Brigham
Keyword(s):  
Disability Evaluation ◽  
Body Part ◽  
Loss Of Function ◽  
Regulatory Requirements ◽  
Major Cardiac Event ◽  
Clinical Scenarios ◽  
Impairment Score ◽  
Occupational Activities ◽  
The Difference

Abstract The author of the two-part article about evaluating reflex sympathetic dystrophy (RSD) responds to criticisms that a percentage impairment score may not adequately reflect the disability of an individual with RSD. The author highlights the importance of recognizing the difference between impairment and disability in the AMA Guides to the Evaluation of Permanent Impairment (AMA Guides): impairment is the loss, loss of use, or derangement of any body part, system, or function; disability is a decrease in or the loss or absence of the capacity to meet personal, social, or occupational demands or to meet statutory or regulatory requirements because of an impairment. The disparity between impairment and disability can be encountered in diverse clinical scenarios. For example, a person's ability to resume occupational activities following a major cardiac event depends on medical, social, and psychological factors, but nonmedical factors appear to present the greatest impediment and many persons do not resume work despite significant improvements in functional capacity. A key requirement according to the AMA Guides is objective documentation, and the author agrees that when physicians consider the disability evaluation of people, more issues than those relating to the percentage loss of function should be considered. More study of the relationships among impairment, disability, and quality of life in patients with RSD are required.

A Review of Failure Handling Mechanisms for Data Quality Measures

2012 ◽  
Author(s):  
Nurul A. Emran ◽  
Noraswaliza Abdullah ◽  
Nuzaimah Mustafa
Keyword(s):  
Data Quality ◽  
Quality Measures ◽  
Failure Handling

The Role of Technological Change in the Long-run Global Economy Forecasting

2013 ◽  
pp. 97-116 ◽  
Author(s):  
A. Apokin
Keyword(s):  
Technological Change ◽  
Data Quality ◽  
Long Range ◽  
Global Economy ◽  
World Economy ◽  
Qualitative Approaches ◽  
Long Run ◽  
The World ◽  
National Economies

The author compares several quantitative and qualitative approaches to forecasting to find appropriate methods to incorporate technological change in long-range forecasts of the world economy. A?number of long-run forecasts (with horizons over 10 years) for the world economy and national economies is reviewed to outline advantages and drawbacks for different ways to account for technological change. Various approaches based on their sensitivity to data quality and robustness to model misspecifications are compared and recommendations are offered on the choice of appropriate technique in long-run forecasts of the world economy in the presence of technological change.

Regulatory and sustainability initiatives lead to improved polyaminopolyamide epichlorohydrin (PAE) wet-strength resins and paper products

TAPPI Journal ◽  
2018 ◽  
Vol 17 (09) ◽  
pp. 519-532 ◽  
Author(s):  
Mark Crisp ◽  
Richard Riehle
Keyword(s):  
Health And Safety ◽  
Cost Effective ◽  
Worker Safety ◽  
Regulatory Requirements ◽  
Wet Strength ◽  
The Past ◽  
Consumer Safety ◽  
Federal Institute ◽  
Sustainability Initiatives ◽  
The Impact

Polyaminopolyamide-epichlorohydrin (PAE) resins are the predominant commercial products used to manufacture wet-strengthened paper products for grades requiring wet-strength permanence. Since their development in the late 1950s, the first generation (G1) resins have proven to be one of the most cost-effective technologies available to provide wet strength to paper. Throughout the past three decades, regulatory directives and sustainability initiatives from various organizations have driven the development of cleaner and safer PAE resins and paper products. Early efforts in this area focused on improving worker safety and reducing the impact of PAE resins on the environment. These efforts led to the development of resins containing significantly reduced levels of 1,3-dichloro-2-propanol (1,3-DCP) and 3-monochloropropane-1,2-diol (3-MCPD), potentially carcinogenic byproducts formed during the manufacturing process of PAE resins. As the levels of these byproducts decreased, the environmental, health, and safety (EH&S) profile of PAE resins and paper products improved. Recent initiatives from major retailers are focusing on product ingredient transparency and quality, thus encouraging the development of safer product formulations while maintaining performance. PAE resin research over the past 20 years has been directed toward regulatory requirements to improve consumer safety and minimize exposure to potentially carcinogenic materials found in various paper products. One of the best known regulatory requirements is the recommendations of the German Federal Institute for Risk Assessment (BfR), which defines the levels of 1,3-DCP and 3-MCPD that can be extracted by water from various food contact grades of paper. These criteria led to the development of third generation (G3) products that contain very low levels of 1,3-DCP (typically <10 parts per million in the as-received/delivered resin). This paper outlines the PAE resin chemical contributors to adsorbable organic halogens and 3-MCPD in paper and provides recommendations for the use of each PAE resin product generation (G1, G1.5, G2, G2.5, and G3).

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