Monitoring Study
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Author | : Robert A. Gitzen |
Publisher | : Cambridge University Press |
Total Pages | : 779 |
Release | : 2012-06-07 |
Genre | : Nature |
ISBN | : 1139510193 |
To provide useful and meaningful information, long-term ecological programs need to implement solid and efficient statistical approaches for collecting and analyzing data. This volume provides rigorous guidance on quantitative issues in monitoring, with contributions from world experts in the field. These experts have extensive experience in teaching fundamental and advanced ideas and methods to natural resource managers, scientists and students. The chapters present a range of tools and approaches, including detailed coverage of variance component estimation and quantitative selection among alternative designs; spatially balanced sampling; sampling strategies integrating design- and model-based approaches; and advanced analytical approaches such as hierarchical and structural equation modelling. Making these tools more accessible to ecologists and other monitoring practitioners across numerous disciplines, this is a valuable resource for any professional whose work deals with ecological monitoring. Supplementary example software code is available online at www.cambridge.org/9780521191548.
Author | : William F. Salminen |
Publisher | : Academic Press |
Total Pages | : 263 |
Release | : 2012-12-31 |
Genre | : Technology & Engineering |
ISBN | : 0123978319 |
Nonclinical Study Contracting and Monitoring: A Practical Guide offers a systematic and straightforward handbook for obtaining high quality preclinical Good Laboratory Practice (GLP) studies. This book is full of real-world examples, processes, procedures, useful templates, checklists and sample reports to provide readers with a better understanding of exactly what happens during all stages of a GLP study and the critical aspects of GLP study design and conduct. Designed for both the novice and experienced scientist, this book covers the GLP regulations and how they impact preclinical studies, the differences between GLP, non-GLP and peer-reviewed studies, preclinical GLP study design, laboratory selection, contracts and business ethics, how to obtain test material for the study, animal sourcing and release for study, preparation of a draft report and much more. By illustrating the overall big picture and tying it together with the individual steps, this book is an essential resource to help scientists ensure a high quality GLP study that passes both scientific and regulatory scrutiny. - Includes both the "big picture" look at complex processes, such as contracting toxicology and safety studies with CROs, as well as a detailed account of each individual step - Contains several real world examples of problems in preclinical studies to provide you with an idea of the types of challenges that are routinely encountered and how this book can help you avoid these issues - Provides monitoring checklists through the book that will help you comply with each GLP requirement and maintain compliance throughout the entire process - Both entry level and experienced scientists involved in nonclinical toxicology study monitoring will benefit from the ideas, examples, discussions and strategies presented throughout this book
Author | : David L. DeMets |
Publisher | : Springer Science & Business Media |
Total Pages | : 389 |
Release | : 2006-06-22 |
Genre | : Medical |
ISBN | : 0387301070 |
From the authors of "Fundamentals of Clinical Trials" which has sold over 15,000 copies world wide since its publication in 1998. No competition yet as the text does not focus on how to do clinical trials but on very specific situations that can be encountered during the process.
Author | : Karen E. Woodin |
Publisher | : CenterWatch |
Total Pages | : 448 |
Release | : 2003-01-01 |
Genre | : Medical |
ISBN | : 9781930624375 |
Author | : Alexis Le Pichon |
Publisher | : Springer Science & Business Media |
Total Pages | : 739 |
Release | : 2010-01-19 |
Genre | : Science |
ISBN | : 1402095082 |
The use of infrasound to monitor the atmosphere has, like infrasound itself, gone largely unheard of through the years. But it has many applications, and it is about time that a book is being devoted to this fascinating subject. Our own involvement with infrasound occurred as graduate students of Prof. William Donn, who had established an infrasound array at the Lamont-Doherty Geological Observatory (now the Lamont-Doherty Earth Observatory) of Columbia University. It was a natural outgrowth of another major activity at Lamont, using seismic waves to explore the Earth’s interior. Both the atmosphere and the solid Earth feature velocity (seismic or acoustic) gradients in the vertical which act to refract the respective waves. The refraction in turn allows one to calculate the respective background structure in these mediums, indirectly exploring locations that are hard to observe otherwise. Monitoring these signals also allows one to discover various phenomena, both natural and man-made (some of which have military applications).
Author | : Susan S. Ellenberg |
Publisher | : John Wiley & Sons |
Total Pages | : 208 |
Release | : 2003-01-17 |
Genre | : Mathematics |
ISBN | : 0470854154 |
There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities. * Provides a practical overview of data monitoring in clinical trials. * Describes the purpose, responsibilities and operation of data monitoring committees. * Provides directly applicable advice for those managing and conducting clinical trials, and those serving on data monitoring committees. * Gives insight into clinical data monitoring to those sitting on regulatory and ethical committees. * Discusses issues pertinent to those working in clinical trials in both the US and Europe. The practical guidance provided by this book will be of use to professionals working in and/or managing clinical trials, in academic, government and industry settings, particularly medical statisticians, clinicians, trial co-ordinators, and those working in regulatory affairs and bioethics.
Author | : Weichung Joe Shih |
Publisher | : CRC Press |
Total Pages | : 405 |
Release | : 2021-10-25 |
Genre | : Medical |
ISBN | : 1000462757 |
Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes five new chapters. Developed from the authors’ courses taught to public health and medical students, residents, and fellows during the past 20 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. The book begins with ethical and safety principles, core trial design concepts, the principles and methods of sample size and power calculation, and analysis of covariance and stratified analysis. It then focuses on sequential designs and methods for two-stage Phase II cancer trials to Phase III group sequential trials, covering monitoring safety, futility, and efficacy. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, phase 2/3 seamless design and trials with predictive biomarkers, exploit multiple testing procedures, and explain the concept of estimand, intercurrent events, and different missing data processes, and describe how to analyze incomplete data by proper multiple imputations. This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students and practitioners a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of trials. The book’s balanced set of homework assignments and in-class exercises are appropriate for students and researchers in (bio)statistics, epidemiology, medicine, pharmacy, and public health.
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 313 |
Release | : 2003-02-06 |
Genre | : Medical |
ISBN | : 0309084881 |
When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, the national spotlight focused on the procedures used to ensure research participants' safety and their capacity to safeguard the well-being of those who volunteer for research studies. Responsible Research outlines a three-pronged approach to ensure the protection of every participant through the establishment of effective Human Research Participant Protection Programs (HRPPPs). The approach includes: Improved research review processes, Recognition and integration of research participants' contributions to the system, and Vigilant maintenance of HRPPP performance. Issues addressed in the book include the need for in-depth, complimentary reviews of science, ethics, and conflict of interest reviews; desired qualifications for investigators and reviewers; the process of informed consent; federal and institutional oversight; and the role of accreditation. Recommendations for areas of key interest include suggestions for legislative approaches, compensation for research-related injury, and the refocusing of the mission of institutional review boards. Responsible Research will be important to anyone interested in the issues that are relevant to the practice of using human subjects as research participants, but especially so to policy makers, research administrators, investigators, and research sponsorsâ€"but also including volunteers who may agree to serve as research participants.
Author | : |
Publisher | : |
Total Pages | : 284 |
Release | : 1977 |
Genre | : College students |
ISBN | : |
Author | : United States. Congress. House. Committee on Science and Technology. Subcommittee on Science, Research, and Technology |
Publisher | : |
Total Pages | : 302 |
Release | : 1984 |
Genre | : Legislative oversight |
ISBN | : |