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The 13-digit and 10-digit formats both work. Please try again.Please try again.Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites. Then you can start reading Kindle books on your smartphone, tablet, or computer - no Kindle device required. In order to navigate out of this carousel please use your heading shortcut key to navigate to the next or previous heading. In order to navigate out of this carousel please use your heading shortcut key to navigate to the next or previous heading.
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Register a free business account Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events.
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Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites. Kate Davis is Business Development Specialist for DCRI Communications Group, Durham, NC, US. To calculate the overall star rating and percentage breakdown by star, we don’t use a simple average. Instead, our system considers things like how recent a review is and if the reviewer bought the item on Amazon. It also analyzes reviews to verify trustworthiness. Please try again later. LindsayM 5.0 out of 5 stars It is written to an audience that is new to research, so everything is explained thoroughly and with historical background for reference and relevance. I would recommend this to anyone wanting to learn more about clinical trials, research, and regulations.I still have it and still refer to it here and there:) I highly recommend this book!!!Fool of pertinent information related to my work.It is fantastic! It is easy to read and gives you a great overview of the research profession and how it evolved. Also has form samples.Promptly deliveredIt is well written and actually enjoyable to read.
I have literally take this book with me to waiting rooms as my choice of leisure reading while I wait. The layout of the book is user friendly too.Full of information and I know it will come in handy for years down the line.Sorry, we failed to record your vote. Please try again. The 13-digit and 10-digit formats both work. Please try again.Please try again.Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites. Then you can start reading Kindle books on your smartphone, tablet, or computer - no Kindle device required. In order to navigate out of this carousel please use your heading shortcut key to navigate to the next or previous heading.
Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context.
This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites. Kate Davis is Business Development Specialist for DCRI Communications Group, Durham, NC, US. To calculate the overall star rating and percentage breakdown by star, we don’t use a simple average. Instead, our system considers things like how recent a review is and if the reviewer bought the item on Amazon. It also analyzes reviews to verify trustworthiness. Please try again later. LindsayM 5.0 out of 5 stars It is written to an audience that is new to research, so everything is explained thoroughly and with historical background for reference and relevance. I would recommend this to anyone wanting to learn more about clinical trials, research, and regulations.I still have it and still refer to it here and there:) I highly recommend this book!!!Fool of pertinent information related to my work.It is fantastic! It is easy to read and gives you a great overview of the research profession and how it evolved. Also has form samples.Promptly deliveredIt is well written and actually enjoyable to read. I have literally take this book with me to waiting rooms as my choice of leisure reading while I wait. The layout of the book is user friendly too.Full of information and I know it will come in handy for years down the line.
Sorry, we failed to record your vote. Please try again In order to navigate out of this carousel please use your heading shortcut key to navigate to the next or previous heading. As advances in information technology make itDesigned for investigators, researchTopics include Good Clinical Practice, informed consent, managementEthical documentsThis graphically appealing andThe roles andThis manual also provides. Would you like to change to the United States site? To download and read them, users must install the VitalSource Bookshelf Software. E-books have DRM protection on them, which means only the person who purchases and downloads the e-book can access it. E-books are non-returnable and non-refundable.This is a dummy description.This is a dummy description.This is a dummy description.This is a dummy description.Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents.
This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites. Kate Davis is Business Development Specialist for DCRI Communications Group, Durham, NC, US. Lessons from a horse named Jim. Published by Wiley-Blackwell: Chichester, UK. 2010. 406 pp, ISBN: 978-1-4051-9515-7. Author information Article notes Copyright and License information Disclaimer Quintiles, Bracknell, Berkshire, UK Dipti Amin, Station House, Market Street, Bracknell, Berkshire, RG12 1HX, UK. Lessons from a horse named Jim’ is the second edition of this practical guide to conducting clinical trials written from the investigator perspective and authored by Margaret Liu and Kate Davis, both with personal experience of conducting trials. It sets out with the intent to provide novice clinical researchers with a manual on how to conduct clinical trials of medicines and devices and the particular points of importance for an investigator. There is much practical advice on how to achieve trial success while ensuring the vital tenets of patient safety and data integrity. Chapters 8 through to 14 are full of practical steps, tips and factors to consider when carrying out an investigational medicinal product or device trial in patients. The last chapter brings in the international perspective on clinical trials with its focus on cross-cultural sensitivities, the impact and importance of genetic variations, on-going initiatives and the advances made in the big infectious diseases that still kill millions worldwide such as malaria, TB, HIV, and where the authors believe future efforts should be directed.
My particular favourite was the first chapter with the historical background which was enjoyable reading in itself, whilst for those new to clinical trials it helps put a perspective on the necessity for heavy regulation and governance in this domain. The extensive appendices provide a valuable resource for key reference documents and templates for use in clinical trials. The authors do make it clear that this is a book primarily about interventional clinical trials of drugs and devices with a brief reference to non-interventional trials. There is excellent use of boxed information providing summaries of topics discussed, anecdotes and examples to illustrate points made in the text, historical snippets such as the origin of randomization, examples of trials demonstrating a particular design or endpoint, to emphasize key points, as well as content summary boxes at the start of chapters. One that particularly appealed to me is the use of quotes at the beginning of chapters. All these different additions help to animate what could otherwise make for rather dry reading. It is clear from the examples provided, such as the optimum way to ask subjects about adverse events without biasing the response and other references to the practicalities of study conduct, that the authors have been involved in conducting trials hands-on and have a clear understanding of the responsibilities of investigators although neither is a clinician. It was pleasing to see that safety reporting is given appropriate importance with a chapter dedicated to describing what needs to be reported to whom, when and why. Chapter 11 provides good practical tips on keeping patients motivated and maximizing retention on studies although I can't help wondering how many investigators have the time and resources to do all this realistically, especially without a Clinical Research Co-ordinator. This book is written in easy to read, simple language that eases assimilation of the information.
The layout is friendly to the eye and enhances information absorption. It is however, US-centric in its description of processes, procedures and requirements from a regulatory and ethics perspective. There are extensive references to the US Code of Federal Regulations throughout with some general references to global standards such as ICH GCP. Whilst this is understandable given that the USA is a major research arena and the single biggest market for medicines, more references to regulations and ethical requirements in Europe would have enhanced the utility of this book outside the USA. Nonetheless, although this book may have been written for primarily a US readership, it is a useful text for understanding the principles and the practical elements of clinical trial conduct, and a useful manual for anyone wishing to conduct clinical trials anywhere in the world. Competing Interests DA is the Senior Vice President and Chief Compliance Officer at Quintiles Transnational and declares this in the interest of transparency. Articles from British Journal of Clinical Pharmacology are provided here courtesy of British Pharmacological Society. Some features of WorldCat will not be available.By continuing to use the site, you are agreeing to OCLC’s placement of cookies on your device. Find out more here. Numerous and frequently-updated resource results are available from this WorldCat.org search. OCLC’s WebJunction has pulled together information and resources to assist library staff as they consider how to handle coronavirus issues in their communities.However, formatting rules can vary widely between applications and fields of interest or study. The specific requirements or preferences of your reviewing publisher, classroom teacher, institution or organization should be applied. Please enter recipient e-mail address(es). Please re-enter recipient e-mail address(es). Please enter your name. Please enter the subject. Please enter the message.
Author: Margaret B Liu; Kate Davis; Duke Clinical Research Institute. Publisher: Chichester, West Sussex, UK; Hoboken, NJ: Wiley-Blackwell, 2010.Please select Ok if you would like to proceed with this request anyway. All rights reserved. You can easily create a free account. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites. Kate Davis is Business Development Specialist for DCRI Communications Group, Durham, NC, US. The roles and responsibilities of institutional review boards and recent developments regarding subject privacy concerns and regulations are well covered.
Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents.This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents.This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context.
Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents.This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.Condition: New. New copy - Usually dispatched within 4 working days. This second edition details new laws and regulations in protecting children participating in clinical trials and how a new focus on privacy of individual health information in the United States has changed how medical records are handled.All Rights Reserved. Det innebar att du inte kan kopiera och anvanda filen hur som helst, utan den ar knuten till dig som kopare. For att kunna lasa boken behover du ett Adobe-medlemsskap, ett Adobe ID. Att skaffa ett Adobe ID ar gratis och tar bara nagon minut. Du registrerar ditt Adobe ID i var app forsta gangen du laddar ned en Adobe DRM-krypterad bok i appen.Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context.
This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites. Jag forstar. This brand new edition details new laws and regulations in protecting children participating in clinical trials and how a new focus on privacy of individual health information in the United States has changed how medical records are handled.Add more references Sven Ove Hansson - 2006 - Theoretical Medicine and Bioethics 27 (2):149-167. Informed Consent in Emergency Research: A Contradiction in Terms. Malcolm G. Booth - 2007 - Science and Engineering Ethics 13 (3):351-359. The Protection of Patients' Rights in Clinical Trials. Marek Czarkowski - 2006 - Science and Engineering Ethics 12 (1):131-138. Using Empirical Data to Inform the Ethical Evaluation of Placebo Controlled Trials. Jeremy Sugarman - 2004 - Science and Engineering Ethics 10 (1):29-35. The Breast Cancer Research Scandal: Addressing the Issues. Charles Weijer - unknown Characterizing the Population in Clinical Trials: Barriers, Comparability, and Implications for Review. Charles Weijer - unknown The Research Misconception. Maurie Markman - 2004 - International Journal of Applied Philosophy 18 (2):241-252. If you want NextDay, we can save the other items for later. Order by, and we can deliver your NextDay items by.
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