Writing Clinical Research Protocols PDF Download
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Author | : Evan DeRenzo |
Publisher | : Elsevier |
Total Pages | : 320 |
Release | : 2005-09-08 |
Genre | : Medical |
ISBN | : 0080454208 |
Download Writing Clinical Research Protocols Book in PDF, ePub and Kindle
This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. Writing Clinical Research Protocols includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This is an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol Includes a chapter containing Case Histories Contains information on conducting clinical research within the pharmaceutical industry An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations
Author | : Evan DeRenzo |
Publisher | : Academic Press |
Total Pages | : 368 |
Release | : 2020-06-25 |
Genre | : Medical |
ISBN | : 0123869358 |
Download Ethical Considerations When Preparing a Clinical Research Protocol Book in PDF, ePub and Kindle
Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources about research ethics, along with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more. Walks investigators and trainees through the identification of the ethical aspects of each section of a clinical research protocol Includes case histories that illustrate key points Contains information on conducting clinical research within the pharmaceutical industry Includes internet resources and worldwide web addresses for important research ethics documents and regulations Contains a chapter on Study Design and Methodology that is purposely expanded to explicitly address biostatistical considerations
Author | : Sue Fitzpatrick |
Publisher | : Inst of Clinical Research |
Total Pages | : 48 |
Release | : 2005-12 |
Genre | : Clinical trials |
ISBN | : 1905238045 |
Download The Clinical Trial Protocol Book in PDF, ePub and Kindle
Author | : Colleen Aldous |
Publisher | : Juta |
Total Pages | : 96 |
Release | : 2011-09-01 |
Genre | : Clinical trials |
ISBN | : 9780702188947 |
Download Writing Your First Clinical Research Protocol Book in PDF, ePub and Kindle
Students embarking on their first clinical research protocol are often daunted by the task at hand, particularly by the statistical terminology, concepts and the choice of appropriate statistical tests. The authors understand the difficulties and pitfalls students might encounter and have written an introductory text that will make writing that first protocol 'a breeze'. Beginning with a section entitled 'Whats in it for me', which outlines the benefits of research, the text provides ideas and advice on topics such as finding the research focus, writing the proposal, considering ethical requirements, compiling a budget and writing the executive summary.
Author | : Evan DeRenzo |
Publisher | : Academic Press |
Total Pages | : 320 |
Release | : 2005-08-18 |
Genre | : Medical |
ISBN | : 9780122107511 |
Download Writing Clinical Research Protocols Book in PDF, ePub and Kindle
This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. Writing Clinical Research Protocols includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This is an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol Includes a chapter containing Case Histories Contains information on conducting clinical research within the pharmaceutical industry An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations
Author | : K. Ashish |
Publisher | : O2 Publications |
Total Pages | : 174 |
Release | : 2014-06-01 |
Genre | : |
ISBN | : 9788192853741 |
Download 9 Steps Guide on How to Write a Clinical Trial Protocol? Book in PDF, ePub and Kindle
This book "9 Steps Guide On How To Write A Clinical Trial Protocol" is specially designed for the Clinical Trial investigators, Physicians, Sponsors, healthcare students and other clinical research professionals, who are involved or keen to explore clinical research in future to develop skills to write protocol for clinical studies. The books covers the topics Essential Clinical Trial Documents, Protocol Structure, Type of Research Studies, Trial Design Consideration, Ethical Consideration, Elementary Statistics, Randomization and its type, Blinding, Sample Sizing etc.The book is designed and written in a manner so that a reader can understand overall protocol writing and the essential element involved in it. We hope that the book would guide the readers to understand the overall process of protocol writing and impart essential skills involved in it.
Author | : Evan DeRenzo |
Publisher | : Academic Press |
Total Pages | : 370 |
Release | : 2020-06-12 |
Genre | : Medical |
ISBN | : 0123869544 |
Download Ethical Considerations When Preparing a Clinical Research Protocol Book in PDF, ePub and Kindle
Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources about research ethics, along with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more. Walks investigators and trainees through the identification of the ethical aspects of each section of a clinical research protocol Includes case histories that illustrate key points Contains information on conducting clinical research within the pharmaceutical industry Includes internet resources and worldwide web addresses for important research ethics documents and regulations Contains a chapter on Study Design and Methodology that is purposely expanded to explicitly address biostatistical considerations
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 304 |
Release | : 2015-04-20 |
Genre | : Medical |
ISBN | : 0309316324 |
Download Sharing Clinical Trial Data Book in PDF, ePub and Kindle
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Author | : John I. Gallin |
Publisher | : Elsevier |
Total Pages | : 447 |
Release | : 2011-04-28 |
Genre | : Science |
ISBN | : 0080489567 |
Download Principles and Practice of Clinical Research Book in PDF, ePub and Kindle
The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government
Author | : M. F. Fathalla |
Publisher | : WHOROEM |
Total Pages | : 234 |
Release | : 2004 |
Genre | : Medical |
ISBN | : 9789290213635 |
Download A Practical Guide for Health Researchers Book in PDF, ePub and Kindle
Health researchers, the intended audience of this book, are not limited to scientists pursuing a research career. They include health professionals, administrators, policymakers and non-governmental organizations, among others, who can and should use the scientific method to guide their work for improving the health of individuals and communities. Even if they do not pursue much research themselves, they need to grasp the principles of the scientific method, to understand the value and also the limitations of science, and to be able to assess and evaluate results of research before applying them. This book includes the following chapters: Introduction and overview; ethics in health research; what research to do; planning the research; writing the research protocol; submitting a research proposal; implementing the research project; describing and analysing the research results; communicating research; guidelines on writing a scientific paper; publishing a scientific paper; guidelines on making a scientific presentation; assessing and evaluating research.