scholarly journals Data quality objectives for regulatory requirements for hazardous and radioactive air emissions sampling and analysis

1995 ◽  
Author(s):  
C.H. Mulkey ◽  
K.D. Markillie
Keyword(s):  
Data Quality ◽  
Air Emissions ◽  
Regulatory Requirements

Data Quality Objectives Supporting Radiological Air Emissions Monitoring for the PNNL Richland Campus

2017 ◽  
Author(s):  
Sandra F. Snyder ◽  
Donna Grace L. Moleta ◽  
Kirsten M. Meier ◽  
John M. Barnett
Keyword(s):  
Data Quality ◽  
Air Emissions

scholarly journals Data Quality Objectives Supporting Radiological Air Emissions Monitoring for the PNNL Site

2012 ◽  
Author(s):  
J. Matthew Barnett ◽  
Kirsten M. Meier ◽  
Sandra F. Snyder ◽  
Brad G. Fritz ◽  
Theodore M. Poston ◽  
...  
Keyword(s):  
Data Quality ◽  
Air Emissions

scholarly journals Data Quality Objectives Supporting Radiological Air Emissions Monitoring for the Marine Sciences Laboratory, Sequim Site

2012 ◽  
Author(s):  
J. Matthew Barnett ◽  
Kirsten M. Meier ◽  
Sandra F. Snyder ◽  
Ernest J. Antonio ◽  
Brad G. Fritz ◽  
...  
Keyword(s):  
Data Quality ◽  
Air Emissions

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.

scholarly journals Data Quality Objectives Supporting Radiological Air Emissions Monitoring for the PNNL Site

2010 ◽  
Author(s):  
J. Matthew Barnett ◽  
Kirsten M. Meier ◽  
Sandra F. Snyder ◽  
Brad G. Fritz ◽  
Ted M. Poston ◽  
...  
Keyword(s):  
Data Quality ◽  
Air Emissions

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.

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