writing clinical research protocols ethical considerations

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Writing Clinical Research Protocols

Author : Evan DeRenzo
ISBN : 0080454208
Genre : Medical
File Size : 79. 15 MB
Format : PDF, Mobi
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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

Ethical And Regulatory Aspects Of Clinical Research

Author : Ezekiel J. Emanuel
ISBN : UOM:39015058788673
Genre : Medical
File Size : 63. 12 MB
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"Many of the chapters easily deserve to be required reading... Most of the readings that have been chosen for the book can lay claim to being classics. They represent sophisticated thinking on various topics." -- Bulletin of the World Health Organization "This book provides excellent matieral on a broad variety of ethical topics in clinical research." -- Quality Assurance Journal All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process.

9 Steps Guide On How To Write A Clinical Trial Protocol

Author : K. Ashish
ISBN : 8192853748
Genre :
File Size : 74. 71 MB
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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.

Clinical Research In Occupational Therapy

Author : Martin Rice
ISBN : 9781133710172
Genre : Medical
File Size : 46. 3 MB
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Thoroughly updated, the 5th edition of CLINICAL RESEARCH IN OCCUPATIONAL THERAPY enables the graduate student and clinical researcher to design and carry out a research study from the formulation of a research hypothesis to collecting data utilizing user friendly step-by-step procedures. An introductory chapter on the history of medical research aquaints the student with the relationship between research and clinical practice. Step-by-step procedures and examples are used throughout to guide the student through the process of selecting a topic, reviewing literature, designing research protocols, selecting outcome measures, implementing research, and writing the results. Descriptive and inferential statistics are explained in a step-by-step procedure, and examples of qualitative and quantitative research are included so as to provide the student with tools to conduct their own research and evaluate current research data. A section on writing questionnaires and surveys helps students construct reliable and valid instruments, and information on scientific writing and thesis preparation is presented. Additionally, ethical considerations for informed consent are addressed, with examples of consent forms included. Important Notice: Media content referenced within the product description or the product text may not be available in the ebook version.

Reviewing Clinical Trials

Author : Chinese University of Hong Kong
ISBN : 9881904110
Genre : Clinical trials
File Size : 81. 41 MB
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The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet (http://www.ClinicalTrialMagnifier.com) and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide.

A Guide To Clinical Drug Research

Author : A. Cohen
ISBN : 0792361725
Genre : Medical
File Size : 89. 55 MB
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Following the success of the first edition, published in 1995, this fully rewritten A Guide to Clinical Drug Research - Second Edition has been adapted to the most recent guidelines and developments in the field. It continues to provide a wealth of practical advice, ranging from the conception of an idea, planning a study and writing a protocol, through to the conduct of a study, data collection and analysis, and publication. It tells investigators what information they should expect sponsoring companies to provide, particularly when there is only limited information available about a new drug. It also explains what the company can expect of investigators, including the requirements of `good clinical practice'. Unlike other currently available texts on clinical trials and pharmaceutical medicine, A Guide to Clinical Drug Research concentrates on the needs of the practising clinician and research team. It is not restricted to drug investigation, and is relevant to all those involved in clinical research in a variety of settings. Audience: Required reading for clinical researchers and others involved as investigators in a drug project, often sponsored by a pharmacuetical company, plus agents of the sponsoring companies themselves.

Principles Of Research Methodology

Author : Phyllis G. Supino
ISBN : 9781461433606
Genre : Medical
File Size : 76. 25 MB
Format : PDF, ePub
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Principles of Research Methodology: A Guide for Clinical Investigators is the definitive, comprehensive guide to understanding and performing clinical research. Designed for medical students, physicians, basic scientists involved in translational research, and other health professionals, this indispensable reference also addresses the unique challenges and demands of clinical research and offers clear guidance in becoming a more successful member of a medical research team and critical reader of the medical research literature. The book covers the entire research process, beginning with the conception of the research problem to publication of findings. Principles of Research Methodology: A Guide for Clinical Investigators comprehensively and concisely presents concepts in a manner that is relevant and engaging to read. The text combines theory and practical application to familiarize the reader with the logic of research design and hypothesis construction, the importance of research planning, the ethical basis of human subjects research, the basics of writing a clinical research protocol and scientific paper, the logic and techniques of data generation and management, and the fundamentals and implications of various sampling techniques and alternative statistical methodologies. Organized in thirteen easy to read chapters, the text emphasizes the importance of clearly-defined research questions and well-constructed hypothesis (reinforced throughout the various chapters) for informing methods and in guiding data interpretation. Written by prominent medical scientists and methodologists who have extensive personal experience in biomedical investigation and in teaching key aspects of research methodology to medical students, physicians and other health professionals, the authors expertly integrate theory with examples and employ language that is clear and useful for a general medical audience. A major contribution to the methodology literature, Principles of Research Methodology: A Guide for Clinical Investigators is an authoritative resource for all individuals who perform research, plan to perform it, or wish to understand it better.

Principles And Practice Of Clinical Research

Author : John I. Gallin
ISBN : 9780123821683
Genre : Medical
File Size : 51. 57 MB
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The third 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

Clinical Research What It Is And How It Works

Author : Lori A. Nesbitt
ISBN : 0763731366
Genre : Health & Fitness
File Size : 70. 57 MB
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Clinical Research will provide you with a fundamental, yet comprehensive, understanding of all phases of the clinical research process. It is ideal for those new to the field seeking a basic understanding of the entire clinical research process, as well as students of the health care professions who may conduct clinical research in their future careers.

Rheumatology

Author : Marc C. Hochberg
ISBN : 9780702063039
Genre : Medical
File Size : 47. 80 MB
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Stay current in the ever-changing discipline of rheumatology with clear, reliable guidance from Hochberg’s Rheumatology, one of the most respected and trusted sources in the field. Designed to meet the needs of the practicing clinician, this medical reference book provides extensive, authoritative coverage of rheumatic diseases from basic scientific principles to practical points of clinical management in a lucid, logical, user-friendly manner. Track disease progression and treat patients more effectively with the information on genetic findings, imaging outcomes, cell and biologic therapies, rheumatoid arthritis, and SLE. Incorporate recent findings about pathogenesis of disease; imaging outcomes for specific diseases like RA, osteoarthritis, and spondyloarthropathies; cell and biologic therapies; and other timely topics. Remain up to date on the latest information in rheumatology through 13 brand-new chapters covering biomedical and translation science, disease and outcome assessment, new imaging modalities, early emerging disease, clinical therapeutics, patient management, and rehabilitation. Take advantage of expanded coverage of small molecule treatment, biologics, biomarkers, epigenetics, biosimilars, and cell-based therapies. Focus on the core knowledge needed for successful results with each chapter co-authored by an internationally-renowned specialist in the field. Easily find the information you need thanks to a consistent, user-friendly format with templated content and large-scale images.

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