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I R B Information Workbook
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Book Synopsis Institutional Review Board by : Elizabeth A. Bankert
Download or read book Institutional Review Board written by Elizabeth A. Bankert and published by Jones & Bartlett Learning. This book was released on 2006 with total page 568 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive reference covers three separate areas related to IRBs: administration, daily management; and ethical issues. This instructional manual provides IRB members and administrators with the information they need to run an efficient and effective system of protecting human research subjects, while remaining in compliance with federal research regulations. The text includes case studies, sample forms, and sample policy documents. The updated Second Edition includes seven new chapters: IRB Closure of Study Files, Internet Research, Research in Public Schools, Phase I Clinical Trials in Healthy Volunteers, Vulnerability in Research, Balancing the Risks and Potential Benefits,and HIPAA.
Book Synopsis Institutional Review Board Member Handbook by : Robert J. Amdur
Download or read book Institutional Review Board Member Handbook written by Robert J. Amdur and published by Jones & Bartlett Publishers. This book was released on 2010-10-22 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Essential Resource for All IRB Members! Designed to give Institutional Review Board (IRB) members the information they need to protect the rights and welfare of research subjects in a way that is both effective and efficient, the chapters of the Institutional Review Board Member Handbook are short and to the point. Topic-specific chapters list the criteria IRB members should use to determine how to vote on specific kinds of studies and offer practical advice on what IRB members should do before and during full-committee meetings. NEW CHAPTERS in this Edition Include: * Definition of Human Subject Research, Exempt & Expedited Review Categories * IRB Member Conflict of Interest All chapters are completely updated for 2010 practice! This handbook is an excellent accompaniment to Institutional Review Board: Management and Function, Second Edition and the Study Guide that IRB members can access and refer to quickly and easily.
Book Synopsis A Practical Guide to Managing Clinical Trials by : JoAnn Pfeiffer
Download or read book A Practical Guide to Managing Clinical Trials written by JoAnn Pfeiffer and published by CRC Press. This book was released on 2017-05-18 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
Book Synopsis Social Work Research Skills Workbook by : Jacqueline Corcoran
Download or read book Social Work Research Skills Workbook written by Jacqueline Corcoran and published by Oxford University Press. This book was released on 2012-09-06 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: With an abundance of examples and exercises, this practically oriented workbook presents a step-by-step approach to help social work students develop and implement their research projects in human services organizations.
Book Synopsis Student Study Guide With IBM® SPSS® Workbook for Research Methods for the Behavioral Sciences by : Gregory J. Privitera
Download or read book Student Study Guide With IBM® SPSS® Workbook for Research Methods for the Behavioral Sciences written by Gregory J. Privitera and published by SAGE Publications. This book was released on 2019-01-24 with total page 183 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study guide for Gregory J. Privitera’s best-selling Research Methods for the Behavioral Sciences, Third Edition includes a review of chapter learning objectives, chapter summaries, and tips and cautions. To help students practice their skills, the guide offers quizzes and exercises accompanied by answers keys; SPSS in Focus exercises with general instructions complement those in Privitera’s main text.
Download or read book CIP Exam Workbook written by Pramod Lad and published by . This book was released on 2018-09-02 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: PRODUCT DESCRIPTION The Institutional Review Board (IRB) is responsible for the review of a wide variety of clinical research. As the complexity of clinical research has grown over the years, the duties and responsibilities of the IRB have grown increasingly complex. This complex environment demands that the IRB be staffed and managed by professionals. As a part of affirming the professionalism of IRB staff, administrators and directors, the Public Responsibility in Research and Medicine (PRIM&R) provides an important forum for education and affirmation of ethical standards for the performance and management of clinical research. An important component of this program is the certification exam known as the CIP (Certified IRB Professional). This examination, which is offered twice a year, covers a wide range of regulatory topics. This workbook provides one tool for the preparation and study for the CIP examination. The book addresses the key issues in federal regulations outlined in statutes including Title 45 part 46 (Protection of Human Subjects) , Title 21 part 50 ( Protection of Human Subjects), Title 21 part 56 (Institutional review Boards) Title 21 part 54 (Financial Disclosures by Clinical Investigators) . Also addressed are key FDA statutes involved in the regulation of clinical trials Title 21 part 312 (Investigational New Drug Application), Tile 21 part 812 (Investigational Device Exemptions) and Title 21 part 11(Electronic Records and Electronic Signatures). The CIP exam covers material based not only on these regulations but also on guidances issued by OHRP and the FDA. Special attention has been devoted to material covered in these guidances. Also addressed are interactions of the IRB with other committees in the institutional environment. Some of the material also covers ICH guidelines for clinical trial management.The workbook is organized in distinct chapters each of which covers one aspect of the regulations or guidances. The multiple choice questions are deliberately designed to instruct on core materials rather offering linguistically ingenious choices. An answer key is provided. The workbook is therefore designed not only to prepare for the CIP examination but also to educate IRB professionals on matters which arise frequently in IRB administration.
Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis The Immortal Life of Henrietta Lacks by : Rebecca Skloot
Download or read book The Immortal Life of Henrietta Lacks written by Rebecca Skloot and published by Crown. This book was released on 2010-02-02 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: #1 NEW YORK TIMES BESTSELLER • “The story of modern medicine and bioethics—and, indeed, race relations—is refracted beautifully, and movingly.”—Entertainment Weekly NOW A MAJOR MOTION PICTURE FROM HBO® STARRING OPRAH WINFREY AND ROSE BYRNE • ONE OF THE “MOST INFLUENTIAL” (CNN), “DEFINING” (LITHUB), AND “BEST” (THE PHILADELPHIA INQUIRER) BOOKS OF THE DECADE • ONE OF ESSENCE’S 50 MOST IMPACTFUL BLACK BOOKS OF THE PAST 50 YEARS • WINNER OF THE CHICAGO TRIBUNE HEARTLAND PRIZE FOR NONFICTION NAMED ONE OF THE BEST BOOKS OF THE YEAR BY The New York Times Book Review • Entertainment Weekly • O: The Oprah Magazine • NPR • Financial Times • New York • Independent (U.K.) • Times (U.K.) • Publishers Weekly • Library Journal • Kirkus Reviews • Booklist • Globe and Mail Her name was Henrietta Lacks, but scientists know her as HeLa. She was a poor Southern tobacco farmer who worked the same land as her slave ancestors, yet her cells—taken without her knowledge—became one of the most important tools in medicine: The first “immortal” human cells grown in culture, which are still alive today, though she has been dead for more than sixty years. HeLa cells were vital for developing the polio vaccine; uncovered secrets of cancer, viruses, and the atom bomb’s effects; helped lead to important advances like in vitro fertilization, cloning, and gene mapping; and have been bought and sold by the billions. Yet Henrietta Lacks remains virtually unknown, buried in an unmarked grave. Henrietta’s family did not learn of her “immortality” until more than twenty years after her death, when scientists investigating HeLa began using her husband and children in research without informed consent. And though the cells had launched a multimillion-dollar industry that sells human biological materials, her family never saw any of the profits. As Rebecca Skloot so brilliantly shows, the story of the Lacks family—past and present—is inextricably connected to the dark history of experimentation on African Americans, the birth of bioethics, and the legal battles over whether we control the stuff we are made of. Over the decade it took to uncover this story, Rebecca became enmeshed in the lives of the Lacks family—especially Henrietta’s daughter Deborah. Deborah was consumed with questions: Had scientists cloned her mother? Had they killed her to harvest her cells? And if her mother was so important to medicine, why couldn’t her children afford health insurance? Intimate in feeling, astonishing in scope, and impossible to put down, The Immortal Life of Henrietta Lacks captures the beauty and drama of scientific discovery, as well as its human consequences.
Book Synopsis Listening to People by : Annette Lareau
Download or read book Listening to People written by Annette Lareau and published by University of Chicago Press. This book was released on 2021-07-23 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book will help you: Understand the importance of talking to others, including listening to feedback from others while conducting research Recognize that there is not only one right way to sculpt your study Learn how to plan the early stages of a project such as designing the study and choosing whom to study See how to navigate the IRB and how to perform practical matters while collecting data Learn how to plan before an interview and how to construct an interview guide Read real-life interviews with notes showing what probes work well and which are less successful A down-to-earth, practical guide for interview and participant observation and analysis. In-depth interviews and close observation are essential to the work of social scientists, but inserting one’s researcher-self into the lives of others can be daunting, especially early on. Esteemed sociologist Annette Lareau is here to help. Lareau’s clear, insightful, and personal guide is not your average methods text. It promises to reduce researcher anxiety while illuminating the best methods for first-rate research practice. As the title of this book suggests, Lareau considers listening to be the core element of interviewing and observation. A researcher must listen to people as she collects data, listen to feedback as she describes what she is learning, listen to the findings of others as they delve into the existing literature on topics, and listen to herself in order to sift and prioritize some aspects of the study over others. By listening in these different ways, researchers will discover connections, reconsider assumptions, catch mistakes, develop and assess new ideas, weigh priorities, ponder new directions, and undertake numerous adjustments—all of which will make their contributions clearer and more valuable. Accessibly written and full of practical, easy-to-follow guidance, this book will help both novice and experienced researchers to do their very best work. Qualitative research is an inherently uncertain project, but with Lareau’s help, you can alleviate anxiety and focus on success.
Book Synopsis Health Information - E-Book by : Mervat Abdelhak
Download or read book Health Information - E-Book written by Mervat Abdelhak and published by Elsevier Health Sciences. This book was released on 2014-12-24 with total page 805 pages. Available in PDF, EPUB and Kindle. Book excerpt: Uncover the latest information you need to know when entering the growing health information management job market with Health Information: Management of a Strategic Resource, 5th Edition. Following the AHIMA standards for education for both two-year HIT programs and four-year HIA programs, this new edition boasts dynamic, state-of-the-art coverage of health information management, the deployment of information technology, and the role of the HIM professional in the development of the electronic health record. An easy-to-understand approach and expanded content on data analytics, meaningful use, and public health informatics content, plus a handy companion website, make it even easier for you to learn to manage and use healthcare data. - Did You Know? boxes highlight interesting facts to enhance learning. - Self-assessment quizzes test your learning and retention, with answers available on the companion Evolve website. - Learning features include a chapter outline, key words, common abbreviations, and learning objectives at the beginning of each chapter, and references at the end. - Diverse examples of healthcare deliveries, like long-term care, public health, home health care, and ambulatory care, prepare you to work in a variety of settings. - Interactive student exercises on Evolve, including a study guide and flash cards that can be used on smart phones. - Coverage of health information infrastructure and systems provides the foundational knowledge needed to effectively manage healthcare information. - Applied approach to Health Information Management and Health Informatics gives you problem-solving opportunities to develop proficiency. - EXPANDED! Data analytics, meaningful use, and public health informatics content prepares HIM professionals for new job responsibilities in order to meet today's, and tomorrow's, workforce needs. - EXPANDED! Emphasis on the electronic health care record educates you in methods of data collection, governance, and use. - NEW! Chapter on data access and retention provides examples of the paper health record and its transition to the EHR. - NEW! Focus on future trends, including specialty certifications offered by the AHIMA, the American Medical Informatics Associations (AMIA), and the Health Information Management Systems Society (HIMSS), explains the vast number of job opportunities and expanded career path awaiting you.
Book Synopsis Regulating Human Research by : Sarah Babb
Download or read book Regulating Human Research written by Sarah Babb and published by . This book was released on 2020 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book traces the historic transformation of institutional review boards (IRBs) from academic committees to compliance bureaucracies. Sarah Babb opens the black box of contemporary IRB decision-making, which is increasingly outsourced to specialized private firms.
Author :Molly J. Bradshaw, DNP, APRN, FNP-BC, WHNP-BC Publisher :Springer Publishing Company ISBN 13 :0826174337 Total Pages :346 pages Book Rating :4.8/5 (261 download)
Book Synopsis The DNP Project Workbook by : Molly J. Bradshaw, DNP, APRN, FNP-BC, WHNP-BC
Download or read book The DNP Project Workbook written by Molly J. Bradshaw, DNP, APRN, FNP-BC, WHNP-BC and published by Springer Publishing Company. This book was released on 2020-03-25 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: Note to Readers: Publisher does not guarantee quality or access to any included digital components if book is purchased through a third-party seller. Streamlines the DNP Project into clear, concrete, and manageable steps Authored by nurse educators with an in-depth understanding of the challenges of the DNP Project, this text provides sequential, guided activities designed to jump-start and project students forward through the DNP Project process. By incorporating active learning activities into project development, the workbook delivers a proven method for developing, implementing, evaluating, and sustaining the DNP Project. It fosters critical thinking and innovation, while also providing a means for faculty to measure and document the progress of project milestones. The DNP Project Workbook offers more than 100 activities that address all facets of the DNP Project, including the identification, investigation, and framing of problems; project team assembly; research; methodology; implementation; and dissemination. This resource also includes examples of a variety of DNP Projects to demonstrate the successful integration of all elements. The activities may be completed within the workbook or in online, editable PDFs for easy submission to faculty. Supplemental resources include PowerPoint slides, a DNP Essentials mapping document, and blank activities and templates. Key Features: Provides sequential, guided activities designed to jump-start and project students forward through the DNP Project process Offers more than 100 active learning activities that address all facets of the DNP Project Delivers a proven method for developing, implementing, evaluating, and sustaining DNP Projects Facilitates measurement and documentation of project milestones Features examples of a variety of DNP Projects Includes a robust resources package, including PowerPoint slides, a DNP Essentials mapping document, and editable activity forms
Book Synopsis Qualitative Research from Start to Finish, First Edition by : Robert K. Yin
Download or read book Qualitative Research from Start to Finish, First Edition written by Robert K. Yin and published by Guilford Press. This book was released on 2011-09-26 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: This lively, practical text presents a fresh and comprehensive approach to doing qualitative research. The book offers a unique balance of theory and clear-cut choices for customizing every phase of a qualitative study. A scholarly mix of classic and contemporary studies from multiple disciplines provides compelling, field-based examples of the full range of qualitative approaches. Readers learn about adaptive ways of designing studies, collecting data, analyzing data, and reporting findings. Key aspects of the researcher's craft are addressed, such as fieldwork options, the five phases of data analysis (with and without using computer-based software), and how to incorporate the researcher's “declarative” and “reflective” selves into a final report. Ideal for graduate-level courses, the text includes:* Discussions of ethnography, grounded theory, phenomenology, feminist research, and other approaches.* Instructions for creating a study bank to get a new study started.* End-of-chapter exercises and a semester-long, field-based project.* Quick study boxes, research vignettes, sample studies, and a glossary.* Previews for sections within chapters, and chapter recaps.* Discussion of the place of qualitative research among other social science methods, including mixed methods research.
Book Synopsis Action Research Essentials by : Dorothy Valcarcel Craig
Download or read book Action Research Essentials written by Dorothy Valcarcel Craig and published by John Wiley & Sons. This book was released on 2009-03-03 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: Action Research Essentials is a practical guide born of the author's own experience working with students in the social sciences and education, providing a step-by-step outline of how to "do" action research--backed by the most extensive theory and research coverage on the market today. The author guides future researcher/practitioners through the action research process via numerous concrete illustrations and a wealth of on-line resources; positioning it as a fundamental component of practice, A key and unique strength of the book is its outreach to a much larger breadth of students than usually found in action research books. This book will illustrate all the steps in action research using examples from education, social work, psychology, sociology, nursing, medicine, and counseling. The structure of the book is intended as the sole textbook for a course devoted to naturalistic inquiry, practitioner research, or beginning qualitative methods, or can complement a general research course.
Book Synopsis Project Management for Researchers by : Shiri Noy
Download or read book Project Management for Researchers written by Shiri Noy and published by University of Michigan Press. This book was released on 2024-11-25 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: A step-by-step guide to developing a research organization system that works for you
Book Synopsis The Sourcebook for Clinical Research by : Natasha Martien
Download or read book The Sourcebook for Clinical Research written by Natasha Martien and published by Academic Press. This book was released on 2018-08-01 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website, so that study teams will be compliant and will find all the necessary tools within this book. Additionally, the authors developed Display Posters for Adverse Events Plus Reporting and Medicare Coverage Analysis that can be purchased separately here: https://www.elsevier.com/books-and-journals/book-companion/9780128162422/order-display-posters. Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic. - Makes vital trial conduct information easy to understand and instructs on how to practically apply current Federal regulations and Good Clinical Practice (ICH GCP) - Offers extensive guidance that is crucial for guaranteeing compliance to clinical research regulations during each step of the clinical research process - Provides up-to-date and extensive coverage of beginning to advanced topics, and, step-by-step actions to take during exceptional circumstances, including compassionate use, emergency use, human subjects protections for vulnerable populations, and federal audits - Furnishes a detailed clinical research Glossary, and a comprehensive Appendix containing ready-to-use forms, templates, and checklists for clinical trial personnel to download and begin using immediately. - Written for the fast-paced clinic environment with action steps and forms in the book to respond to a research subject's needs urgently and compliantly
Book Synopsis The Comprehensive Guide To Clinical Research by : Chris Sauber
Download or read book The Comprehensive Guide To Clinical Research written by Chris Sauber and published by Independently Published. This book was released on 2019-04-21 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: Condensing the most important topics in all of clinical research in an easy to understand presentation. The 20 percent of what you need to know in order to be 80 percent proficient!The authors who have operated various levels of businesses in the clinical research industry since 2005 believe that more practical information pertaining to clinical research needs to be accessible to individuals who are new to the industry or are curious about entering the rewarding world of clinical trials.This book reads in an easy to understand style and is based on proven methods the authors have developed to train their own employees and students of their various clinical research academies throughout the years. Picking this up and absorbing the information will allow anyone to gain much better insight into the complicated dynamics of clinical research. This practical roadmap is all you will need to get started on your clinical trial journey!In this book you will learn about:Regulations and the history as well as evolution of GCP.Clinical Research Site OperationsMonitoring Dynamics and Typical Monitoring VistsCRO ActivitiesSponsor Level DynamicsIndustry VendorsCommon Career Opportunities and Employment Roadmaps
