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| citi good clinical practice course: Good Clinical Practice Guide Gary L. Chadwick, David G. Forster, Cynthia M. Gates, Jamie Gault, JoAnn Giannone, Diane Paul, Deborah Rosenbaum, Carmen Wantowski, Jaime Arango, Karen Arts, Paul Braunschweiger, Karen Hansen, 2012-09-17 The Good Clinical Practice (GCP) Guide is a logical extension of the CITI Program's web-based Good Clinical Practice (GCP) training, and is based on the CITI Program's recognized content. It is intended to serve as a quick reference guide for GCP using Drugs and Biologics as well as Devices. |
| citi good clinical practice course: Educational Principles and Practice in Veterinary Medicine Katherine Fogelberg, 2024-01-04 Educational Principles and Practice in Veterinary Medicine An in-depth, veterinary-centered reference to the discipline of education Educational Principles and Practice in Veterinary Medicine provides a detailed, comprehensive reference to the discipline of education both broadly and as it relates to veterinary medicine. Written for veterinary faculty members, instructors, and educators in other health professions, the book offers an in-depth examination of knowledge and skills related to veterinary education. It discusses educational theory, how people learn, the structure and function of higher education, and educational technologies, among many other topics of importance. Sections cover educational leadership; professional development for faculty; research methods and study design; administration; outcomes and assessment; accreditation; and the roles of the professional program instructor. Educational Principles and Practice in Veterinary Medicine: Provides a detailed exposition to the discipline of education, encompassing both theory and practice Covers essential topics such as educational theory, the structure and function of higher education, and educational technologies, all tailored to veterinary education Acts as a reference to education-related knowledge and skills, with an emphasis on how these topics relate to veterinary medicine Supports veterinary faculty and instructors interested in taking their knowledge and skills to the next level Educational Principles and Practice in Veterinary Medicine offers veterinary faculty and instructors a complete resource for understanding the field of education and improving their skills and knowledge. |
| citi good clinical practice course: Conducting the DNP Project Denise Korniewicz, PhD, RN, FAAN, 2019-09-15 A “how-to” approach to navigating the strenuous path from DNP plan to completed project You completed your DNP proposal and have approval to proceed: What’s next? How do you move from proposal phase to conduct and complete your project? This text is the first to discuss the practical steps to implement and complete the project and will help DNP students to systematically transition from plan to action. Written by an author with extensive experience helping students with their quality improvement projects, the text educates readers on the core components of conducting the clinical scholarly project. With a focus on working effectively with clinical staff, the book addresses IRB approval; ethics; working with human subjects; project planning; collecting, analyzing, and interpreting clinical data; disseminating findings; and how to complete the project in a timely manner. It discusses interprofessional collaboration, team building, and how to debrief project participants. Examples of successful scholarly projects and recommendations for project improvement offer additional guidance, along with consideration of common problems that many students face and how to resolve them. Objectives and review questions are provided in selected chapters. Key Features: Delivers practical, step-by-step strategies for implementing and completing the DNP project Focuses on finding and effectively communicating with team members Explains how to collect, analyze, and interpret clinical data Describes how to establish protocol for working with patients Offers chapter objectives, review questions, and case studies demonstrating major content components |
| citi good clinical practice course: Research Methods for Child Life Specialists Sarah Daniels, Sherwood Burns-Nader, Jessika Boles, 2021-03-05 In today’s evidence-based healthcare culture, child life specialists must demonstrate knowledge and skill not only in clinical care, but also in planning and evaluating the impact of their interventions—yet few resources exist to provide research skills and support for these practitioners. To adequately evaluate, improve, and innovate patient and family outcomes, it is essential that all providers understand the key inquiry pathways of research. Combining clinical examples and skills with candid advice from seasoned child life specialist researchers, this text scaffolds the concept of inquiry into feasible units of action. From identifying a clinical question to assembling a team, designing a project, collecting and analyzing data, and reporting on results, it guides students, professionals, and administrators in actively exploring and improving healthcare outcomes for patients and their families. Case examples from the authors’ own experiences as clinicians and researchers serve to demonstrate how to seamlessly translate clinical skills into those needed for success in research, ensuring that child life specialists remain active contributors to today’s research evidence on the needs of children and families during healthcare encounters. |
| citi good clinical practice course: A Guide to the Scientific Career Mohammadali M. Shoja, Anastasia Arynchyna, Marios Loukas, Anthony V. D'Antoni, Sandra M. Buerger, Marion Karl, R. Shane Tubbs, 2020-01-09 A concise, easy-to-read source of essential tips and skills for writing research papers and career management In order to be truly successful in the biomedical professions, one must have excellent communication skills and networking abilities. Of equal importance is the possession of sufficient clinical knowledge, as well as a proficiency in conducting research and writing scientific papers. This unique and important book provides medical students and residents with the most commonly encountered topics in the academic and professional lifestyle, teaching them all of the practical nuances that are often only learned through experience. Written by a team of experienced professionals to help guide younger researchers, A Guide to the Scientific Career: Virtues, Communication, Research and Academic Writing features ten sections composed of seventy-four chapters that cover: qualities of research scientists; career satisfaction and its determinants; publishing in academic medicine; assessing a researcher’s scientific productivity and scholarly impact; manners in academics; communication skills; essence of collaborative research; dealing with manipulative people; writing and scientific misconduct: ethical and legal aspects; plagiarism; research regulations, proposals, grants, and practice; publication and resources; tips on writing every type of paper and report; and much more. An easy-to-read source of essential tips and skills for scientific research Emphasizes good communication skills, sound clinical judgment, knowledge of research methodology, and good writing skills Offers comprehensive guidelines that address every aspect of the medical student/resident academic and professional lifestyle Combines elements of a career-management guide and publication guide in one comprehensive reference source Includes selected personal stories by great researchers, fascinating writers, inspiring mentors, and extraordinary clinicians/scientists A Guide to the Scientific Career: Virtues, Communication, Research and Academic Writing is an excellent interdisciplinary text that will appeal to all medical students and scientists who seek to improve their writing and communication skills in order to make the most of their chosen career. |
| citi good clinical practice course: Principles of Good Clinical Practice Michael J. McGraw, 2010 Part of RPS Pharmacy Business Administration Series, this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights. |
| citi good clinical practice course: Qualitative Research, Second Edition Tim Sensing, 2022-07-05 The second edition of Qualitative Research responds to the growing need in Doctor of Ministry programs for a textbook that guides students in Participatory Action Research, prospectus, and dissertation that reflect the recent trends in the discipline of practical theology. The Standards of Accreditation for the Commission on Accrediting of the Association of Theological Schools states, “The Doctor of Ministry is an advanced, professionally oriented degree that prepares people more deeply for religious leadership in congregations and other settings.” Standard 5.3 states, “The Doctor of Ministry degree has clearly articulated student learning outcomes that are consistent with the school’s mission and resources and address the following four areas: (a) advanced theological integration that helps graduates effectively engage their cultural context with theological acumen and critical thinking; (b) in-depth contextual competency that gives graduates the ability to identify, frame, and respond to crucial ministry issues; (c) leadership capacity that equips graduates to enhance their effectiveness as ministry leaders in their chosen settings; and (d) personal and spiritual maturity that enables graduates to reinvigorate and deepen their vocational calling.” In accordance with the standards, Qualitative Research guides students through appropriate research methods to satisfy the objectives of the degree in order to enhance ministerial leadership for the transformation of communities of practice. |
| citi good clinical practice course: Principles and Practice of Clinical Research John I. Gallin, Frederick P Ognibene, 2011-04-28 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 |
| citi good clinical practice course: A Practical Guide to Managing Clinical Trials JoAnn Pfeiffer, Cris Wells, 2017-05-18 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. |
| citi good clinical practice course: Basic Methods Handbook for Clinical Orthopaedic Research Volker Musahl, Jón Karlsson, Michael T. Hirschmann, Olufemi R. Ayeni, Robert G. Marx, Jason L. Koh, Norimasa Nakamura, 2019-02-01 This book is designed to meet the needs of both novice and senior researchers in Orthopaedics by providing the essential, clinically relevant knowledge on research methodology that is sometimes overlooked during training. Readers will find a wealth of easy-to-understand information on all relevant aspects, from protocol design, the fundamentals of statistics, and the use of computer-based tools through to the performance of clinical studies with different levels of evidence, multicenter studies, systematic reviews, meta-analyses, and economic health care studies. A key feature is a series of typical case examples that will facilitate use of the volume as a handbook for most common research approaches and study types. Younger researchers will also appreciate the guidance on preparation of abstracts, poster and paper presentations, grant applications, and publications. The authors are internationally renowned orthopaedic surgeons with extensive research experience and the book is published in collaboration with ISAKOS. |
| citi good clinical practice course: Responsible Conduct of Research Adil E. Shamoo, David B. Resnik, 2009-02-12 Recent scandals and controversies, such as data fabrication in federally funded science, data manipulation and distortion in private industry, and human embryonic stem cell research, illustrate the importance of ethics in science. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today. |
| citi good clinical practice course: Good Clinical Practice Earl W. Hulihan, Mark P. Mathieu, 2020 |
| citi good clinical practice course: Building the Clinical Research Workforce: Challenges, Capacities and Competencies Carolynn Thomas Jones, Barbara E. Bierer, Stephen Sonstein, Hazel Ann Smith, Denise Snyder, 2024-08-05 This is an unprecedented time for clinical research. The number and complexity of clinical research studies have increased significantly in the last decade. Individual participation in clinical research broadened, with an increase in diverse populations, diseases, and geographic settings. The successful execution of these studies, however, has been compromised by an international shortage of clinical research professionals, coupled with an appreciation of the growing number of core competencies necessary for performance. Developed over a decade ago, the Joint Task Force for Clinical Trial Competency (JTF) Framework outlines the knowledge, skills and attitudes that are essential for the safe and effective conduct of a clinical study. This framework has been used to develop professional pathways, trainings, and certification programs and has been extended internationally through translation. |
| citi good clinical practice course: Tearoom Trade Laud Humphreys, 2017-07-12 From the time of its first publication, 'Tearoom Trade' engendered controversy. It was also accorded an unusual amount of praise for a first book on a marginal, intentionally self-effacing population by a previously unknown sociologist. The book was quickly recognized as an important, imaginative, and useful contribution to our understanding of deviant sexual activity. Describing impersonal, anonymous sexual encounters in public restrooms—tearooms in the argot—the book explored the behavior of men whose closet homosexuality was kept from their families and neighbors. By posing as an initiate, the author was able to engage in systematic observation of homosexual acts in public settings, and later to develop a more complete picture of those involved by interviewing them in their homes, again without revealing their unwitting participation in his study. This enlarged edition of 'Tearoom Trade' includes the original text, together with a retrospect, written by Nicholas von Hoffman, Irving Louis Horowitz, Lee Rainwater, Donald P. Warwick, and Myron Glazer. The material added includes a perspective on the social scientist at work and the ethical problems to which that work may give rise, along with debate by the book's initial critics and proponents. Humphreys added a postscript and his views on the opinion expressed in the retrospect. |
| citi good clinical practice course: Clinical Trials Design in Operative and Non Operative Invasive Procedures Kamal M.F. Itani, Domenic J. Reda, 2017-05-16 The aim of this text is to provide the framework for building a clinical trial as it pertains to operative and non operative invasive procedures, how to get it funded and how to conduct such a trial up to publication of results The text provides all details of building a scientifically and ethically valid proposal, including how to build the infrastructure for a clinical trial and how to move it forward through various funding agencies. The text also presents various types of clinical trials, the use of implantable devices and FDA requirements, and adjuncts to clinical trials and interaction with industry Clinical Trials Design in Invasive Operative and Non Operative Procedures will be of interest to all specialists of surgery, anesthesiologists, interventional radiologists, gastroenterologists, cardiologists, and pulmonologists |
| citi good clinical practice course: Institutional Review Board Member Handbook Robert J. Amdur, Elizabeth A. Bankert, 2010-10-22 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. |
| citi good clinical practice course: Nursing Research Janet Houser, Kenneth Oja, 2024-12-17 Nursing Research: Reading, Using, and Creating Evidence, Sixth Edition is a foundational nursing textbook for teaching and learning the basics of creating and using evidence in nursing practice. Written in a conversational tone, the hallmark of this text is its readability and the author's skillfulness in simplifying otherwise complex topics such as evidence-based care, qualitative and quantitative studies, and translation of research to practice. Nurses need to demonstrate proficiency in reading research, determining its use in their practice, and participating in the research process. The Sixth Edition is intuitively organized around the three main competencies - reading, using, and creating evidence - all of which enable the student to translate research into evidence in a practical way. This nursing textbook is intended to teach and support the clinical practice of nursing students, professional nurses returning to school, and practicing nurses that must apply evidence to patient care. |
| citi good clinical practice course: The Comprehensive Guide To Clinical Research Chris Sauber, Dan Sfera, 2019-04-21 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 |
| citi good clinical practice course: Management of Animal Care and Use Programs in Research, Education, and Testing Robert H. Weichbrod, Gail A. (Heidbrink) Thompson, John N. Norton, 2017-09-07 AAP Prose Award Finalist 2018/19 Management of Animal Care and Use Programs in Research, Education, and Testing, Second Edition is the extensively expanded revision of the popular Management of Laboratory Animal Care and Use Programs book published earlier this century. Following in the footsteps of the first edition, this revision serves as a first line management resource, providing for strong advocacy for advancing quality animal welfare and science worldwide, and continues as a valuable seminal reference for those engaged in all types of programs involving animal care and use. The new edition has more than doubled the number of chapters in the original volume to present a more comprehensive overview of the current breadth and depth of the field with applicability to an international audience. Readers are provided with the latest information and resource and reference material from authors who are noted experts in their field. The book: - Emphasizes the importance of developing a collaborative culture of care within an animal care and use program and provides information about how behavioral management through animal training can play an integral role in a veterinary health program - Provides a new section on Environment and Housing, containing chapters that focus on management considerations of housing and enrichment delineated by species - Expands coverage of regulatory oversight and compliance, assessment, and assurance issues and processes, including a greater discussion of globalization and harmonizing cultural and regulatory issues - Includes more in-depth treatment throughout the book of critical topics in program management, physical plant, animal health, and husbandry. Biomedical research using animals requires administrators and managers who are knowledgeable and highly skilled. They must adapt to the complexity of rapidly-changing technologies, balance research goals with a thorough understanding of regulatory requirements and guidelines, and know how to work with a multi-generational, multi-cultural workforce. This book is the ideal resource for these professionals. It also serves as an indispensable resource text for certification exams and credentialing boards for a multitude of professional societies Co-publishers on the second edition are: ACLAM (American College of Laboratory Animal Medicine); ECLAM (European College of Laboratory Animal Medicine); IACLAM (International Colleges of Laboratory Animal Medicine); JCLAM (Japanese College of Laboratory Animal Medicine); KCLAM (Korean College of Laboratory Animal Medicine); CALAS (Canadian Association of Laboratory Animal Medicine); LAMA (Laboratory Animal Management Association); and IAT (Institute of Animal Technology). |
| citi good clinical practice course: Building and Sustaining a Hospital-Based Nursing Research Program Nancy Albert, PhD, CCNS, CCRN, NE-BC, FAHA, FCCM, 2015-11-13 The first resource to present the “nuts and bolts” of creating a successful nursing research program. This text provides a roadmap to develop and nurture a nursing research program in complex hospital environments. Written by experienced clinical researchers who have successfully implemented these techniques in the Cleveland Clinic, the handbook shows nurses how to build and sustain a research program—a fundamental requirement to transform patient care and administrative practices and obtain and sustain American Nurses Credentialing Center Magnet® program recognition. The book demonstrates, step-by-step, how leaders and staff can integrate nursing research into the workflow of complex health care environments. It provides a framework for developing horizontal and vertical structures that promote the creation of new knowledge and for enhancing the scientific foundation of nursing evidence. With a focus on practical applications, the book addresses the structures, systems, processes, and resources required for creating and maintaining a research program along with methods for its evaluation. The handbook describes foundational principles that apply to hospitals of all sizes (including ambulatory centers and hospitals without extensive resources), and provides concrete guidance in adapting structures and processes to fit the needs of hospitals with varied nursing staff size and program goals. Replete with a wealth of ideas and strategies, it provides detailed templates that will assist novice and more experienced researchers, guidelines for committees to support nursing research within a hospital, and discusses the “who,” “what,” “why” of systems that enhance workflow. Chapters offer experiential stories written by nurses who describe the “real world” experiences of implementing clinical research in their practice. Tables and figures further illuminate information. Key Features: Written by experienced researchers who have implemented the techniques used in this book Provides a framework adaptable for use with hospitals of all sizes Includes guidelines for committees/councils to support nursing research within the organization Discusses processes and systems that enhance collaboration and workflow Offers stories from the field by nurses about “lessons learned” from their research experiences |
| citi good clinical practice course: Residency Interview Handbook Chu Qin Phua, 2019-04-23 This book is a 'How to' book that can help medical doctors in career navigation into specialist training in Singapore.With the introduction of the Residency program comes a different set of application process, selection criteria and interview format. This book provides invaluable insight into the current Residency training structure and will help equip readers with strategies to prepare their CVs, giving them an edge over others in the Residency interview.Existing information on Residency Interview or the Selection Process is scattered. There is a huge deficiency in the current market on the subject of interview preparation as well as detailed choice of specialties based on the local climate. This book provides a step-by-step, practical, easy to understand guide to help readers select their medical specialties, prepare their CVs and excel in interviews. |
| citi good clinical practice course: An African Research Ethics Reader , 2024-06-11 Cultural research ethics is in a nascent phase within the field of research ethics as a whole and requires more attention and in-depth articulation. With specific case studies, this vital volume provides unique perspectives on topics such as social autonomy vis-a-vis interests of individuals. This volume assembles needed resources and case studies in cultural research ethics practices, providing insight into current developments and future research directions. It is a valuable contribution to cultural research ethics given the dearth of published literature available in this emerging field. It is designed with two broad audiences in mind: (1) African researchers and research organizations that want homegrown guidance about research ethics, and (2) research ethicists worldwide who can use it to learn about cultural research ethics especially with respect to Africa. |
| citi good clinical practice course: The Belmont Report United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978 |
| citi good clinical practice course: Practice-Based Research R. Trent Codd, III, 2018-05-01 Practice-Based Research shows mental-health practitioners how to establish viable and productive research programs in routine clinical settings. Chapters written by experts in practice-based research use real-world examples to help clinicians work through some of the most common barriers to research output in these settings, including lack of access to institutional review boards, lack of organizational support, and limited access to financial resources. Specialized chapters also provide information on research methods and step-by-step suggestions tailored to a variety of practice settings. This is an essential volume for clinicians interested in establishing successful, long-lasting practice-based research programs. |
| citi good clinical practice course: Public Health Service Policy on Humane Care and Use of Laboratory Animals National Institutes of Health (U.S.). Office for Protection from Research Risks, 1986 |
| citi good clinical practice course: Clinical Dermatology Trials 101 Adnan Nasir, 2014-11-12 Clinical Dermatology Trials 101 provides dermatologists with a handbook that allows them to become familiar with all aspects of clinical trials. Everything from obtaining the necessary tools and equipment, complying with local, federal, and international guidelines and regulations, and hiring and training staff for the safe and up-to-date conduct of dermatology clinical trials is covered. Written by leading experts in the field, Clinical Dermatology Trials 101 is the only clinical trial how-to available for dermatologists. With skin disease affecting nearly seventy percent of the population over a lifetime, and the rate of development of new drugs and devices for dermatologic use increasing at an exponential rate, there is a tremendous need for training and developing dermatology clinical research facilities to expedite the translation of basic and applied research, from bench to bedside. This is useful for practicing dermatologists, academic dermatologists, dermatology residents, clinical research fellows, dermatology fellows, research scientists, industry dermatologists, and medical students. |
| citi good clinical practice course: Biomedical Engineering Design Joseph Tranquillo, Jay Goldberg, Robert Allen, 2022-02-19 Biomedical Engineering Design presents the design processes and practices used in academic and industry medical device design projects. The first two chapters are an overview of the design process, project management and working on technical teams. Further chapters follow the general order of a design sequence in biomedical engineering, from problem identification to validation and verification testing. The first seven chapters, or parts of them, can be used for first-year and sophomore design classes. The next six chapters are primarily for upper-level students and include in-depth discussions of detailed design, testing, standards, regulatory requirements and ethics. The last two chapters summarize the various activities that industry engineers might be involved in to commercialize a medical device. - Covers subject matter rarely addressed in other BME design texts, such as packaging design, testing in living systems and sterilization methods - Provides instructive examples of how technical, marketing, regulatory, legal, and ethical requirements inform the design process - Includes numerous examples from both industry and academic design projects that highlight different ways to navigate the stages of design as well as document and communicate design decisions - Provides comprehensive coverage of the design process, including methods for identifying unmet needs, applying Design for 'X', and incorporating standards and design controls - Discusses topics that prepare students for careers in medical device design or other related medical fields |
| citi good clinical practice course: U.S. Department of Veterans Affairs Research Programs United States. Congress. House. Committee on Veterans' Affairs. Subcommittee on Health, 2008 |
| citi good clinical practice course: A Clinical Trials Manual From The Duke Clinical Research Institute Margaret Liu, Kate Davis, 2011-08-24 The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity. —Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical nuts and bolts approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices. 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. |
| citi good clinical practice course: Fostering Integrity in Research National Academies of Sciences, Engineering, and Medicine, Policy and Global Affairs, Committee on Science, Engineering, Medicine, and Public Policy, Committee on Responsible Science, 2018-01-13 The integrity of knowledge that emerges from research is based on individual and collective adherence to core values of objectivity, honesty, openness, fairness, accountability, and stewardship. Integrity in science means that the organizations in which research is conducted encourage those involved to exemplify these values in every step of the research process. Understanding the dynamics that support †or distort †practices that uphold the integrity of research by all participants ensures that the research enterprise advances knowledge. The 1992 report Responsible Science: Ensuring the Integrity of the Research Process evaluated issues related to scientific responsibility and the conduct of research. It provided a valuable service in describing and analyzing a very complicated set of issues, and has served as a crucial basis for thinking about research integrity for more than two decades. However, as experience has accumulated with various forms of research misconduct, detrimental research practices, and other forms of misconduct, as subsequent empirical research has revealed more about the nature of scientific misconduct, and because technological and social changes have altered the environment in which science is conducted, it is clear that the framework established more than two decades ago needs to be updated. Responsible Science served as a valuable benchmark to set the context for this most recent analysis and to help guide the committee's thought process. Fostering Integrity in Research identifies best practices in research and recommends practical options for discouraging and addressing research misconduct and detrimental research practices. |
| citi good clinical practice course: Scholarship Reconsidered Ernest L. Boyer, Drew Moser, Todd C. Ream, John M. Braxton, 2015-10-06 Shifting faculty roles in a changing landscape Ernest L. Boyer's landmark book Scholarship Reconsidered: Priorities of the Professoriate challenged the publish-or-perish status quo that dominated the academic landscape for generations. His powerful and enduring argument for a new approach to faculty roles and rewards continues to play a significant part of the national conversation on scholarship in the academy. Though steeped in tradition, the role of faculty in the academic world has shifted significantly in recent decades. The rise of the non-tenure-track class of professors is well documented. If the historic rule of promotion and tenure is waning, what role can scholarship play in a fragmented, unbundled academy? Boyer offers a still much-needed approach. He calls for a broadened view of scholarship, audaciously refocusing its gaze from the tenure file and to a wider community. This expanded edition offers, in addition to the original text, a critical introduction that explores the impact of Boyer's views, a call to action for applying Boyer's message to the changing nature of faculty work, and a discussion guide to help readers start a new conversation about how Scholarship Reconsidered applies today. |
| citi good clinical practice course: Section 1557 of the Affordable Care Act American Dental Association, 2017-05-24 Section 1557 is the nondiscrimination provision of the Affordable Care Act (ACA). This brief guide explains Section 1557 in more detail and what your practice needs to do to meet the requirements of this federal law. Includes sample notices of nondiscrimination, as well as taglines translated for the top 15 languages by state. |
| citi good clinical practice course: Handbook for Clinical Research Flora Hammond, MD, James F. Malec, Todd Nick, Ralph Buschbacher, MD, 2014-08-26 With over 80 information-packed chapters, Handbook for Clinical Research delivers the practical insights and expert tips necessary for successful research design, analysis, and implementation. Using clear language and an accessible bullet point format, the authors present the knowledge and expertise developed over time and traditionally shared from mentor to mentee and colleague to colleague. Organized for quick access to key topics and replete with practical examples, the book describes a variety of research designs and statistical methods and explains how to choose the best design for a particular project. Research implementation, including regulatory issues and grant writing, is also covered. The book opens with a section on the basics of research design, discussing the many ways in which studies can be organized, executed, and evaluated. The second section is devoted to statistics and explains how to choose the correct statistical approach and reviews the varieties of data types, descriptive and inferential statistics, methods for demonstrating associations, hypothesis testing and prediction, specialized methods, and considerations in epidemiological studies and measure construction. The third section covers implementation, including how to develop a grant application step by step, the project budget, and the nuts and bolts of the timely and successful completion of a research project and documentation of findings: procedural manuals and case report forms collecting, managing and securing data operational structure and ongoing monitoring and evaluation and ethical and regulatory concerns in research with human subjects. With a concise presentation of the essentials for successful research, the Handbook for Clinical Research is a valuable addition to the library of any student, research professional, or clinician interested in expanding the knowledge base of his or her field. Key Features: Delivers the essential elements, practical insights, and trade secrets for ensuring successful research design, analysis, and implementation Presents the nuts and bolts of statistical analysis Organized for quick access to a wealth of information Replete with practical examples of successful research designs Û from single case designs to meta-analysis - and how to achieve them Addresses research implementation including regulatory issues and grant writing |
| citi good clinical practice course: Prostate Cancer Adam P. Dicker, Adam P. Dicker, MD, PhD, William Kevin Kelly, DO, Nicholas G. Zaorsky, MD, Edouard J. Trabulsi, MD, Charles R Thomas, 2014-12-17 This book admirably covers prostate cancer. It is written in an easily digestible manner for non-experts and emphasizes the importance of a team approach to treatment of patients with this disease.--Doody's Reviews With an emphasis on multidisciplinary collaboration and decision-making, this practical resource reflects the extraordinary advances in the treatment of prostate cancer during the past five years. Approximately thirty international, leading-edge investigators describe the most current evidence-based approaches to prostate cancer treatment. The book provides a comprehensive view of the entire spectrum of prostate cancer management from initial screening through novel and experimental treatments that have the potential for a major impact on practice. The book first reviews fundamental issues including epidemiology, screening, risk reduction, diagnosis and pathologic characterization, staging, and imaging. This includes strategies for improving the accuracy of PSA screening and an update on controversies surrounding the ISUP Modified Gleason Score. The book covers novel molecular and genotype profiling in prostate cancer, including morphometric and systems pathology. Detailed information is provided on radiographic imaging for diagnosis and staging. The treatment sections of the book correspond to the staging of disease. The treatment of localized disease addresses the range of multidisciplinary management options including a discussion of prostate cancer's impact on the quality of life. A detailed review of multimodal therapies (medical, surgical, and radiologic) addresses the treatment of localized advanced disease, and coverage of advanced metastatic prostate cancer reviews current management options including a range of promising novel and experimental agents. The book also discusses counseling the high-risk patient. Several chapters incorporate models of care delivery, patient navigation for multidisciplinary care, genomic and risk assessment, and comparative effects of research in treatment decision-making. The book is designed as a management text for all health care professionals who provide care for prostate cancer patients as well as patients, families, and advocates. Extensive references offer opportunities for additional study. Key Features: Delineates a practical, concise approach to multidisciplinary management of prostate cancer Provides a wide range of perspectives and expertise Written and edited by an international, multidisciplinary team of prostate cancer specialists Focuses on such key issues as special populations, screening controversies, patient counseling, and quality of life Includes discussion of important emerging topics such as gene profiling and targeted therapies and comparative effectiveness data |
| citi good clinical practice course: Good Practice of Clinical Drug Trials Alain Spriet, Thérèse Dupin-Spriet, 2005 This new edition of `Good Practice' is a totally revised and expanded version of this work. It takes into account the new quality guidelines, in particular those listed in the European Union Directive, the application texts and the recommendations of the International Conference on Harmonisation (ICH). It is a practical manual to help you conduct your clinical trials. Many new or revised concepts have been included, in particular: - Rationale for each rule presented - Safety of data in clinical trials - Protection of personal data - Conflicts of interest - Measures to be taken in case of suspected fraud |
| citi good clinical practice course: Principles and Practice of Ophthalmology E-Book Daniel M. Albert, Joan W. Miller, Dimitri T. Azar, Barbara A. Blodi, 2008-02-27 Inside the 3rd edition of this esteemed masterwork, hundreds of the most distinguished authorities from around the world provide today's best answers to every question that arises in your practice. They deliver in-depth guidance on new diagnostic approaches, operative technique, and treatment option, as well as cogent explanations of every new scientific concept and its clinical importance. With its new streamlined, more user-friendly, full-color format, this 3rd edition makes reference much faster, easier, and more versatile. More than ever, it's the source you need to efficiently and confidently overcome any clinical challenge you may face. Comprehensive, authoritative, and richly illustrated coverage of every scientific and clinical principle in ophthalmology ensures that you will always be able to find the guidance you need to diagnose and manage your patients' ocular problems and meet today's standards of care. Updates include completely new sections on Refractive Surgery and Ethics and Professionalism... an updated and expanded Geneitcs section... an updated Retina section featuring OCT imaging and new drug therapies for macular degeneration... and many other important new developments that affect your patient care. A streamlined format and a new, more user-friendly full-color design - with many at-a-glance summary tables, algorithms, boxes, diagrams, and thousands of phenomenal color illustrations - allows you to locate the assistance you need more rapidly than ever. |
| citi good clinical practice course: Women and Health Research Institute of Medicine, Committee on Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies, 1994-02-01 In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues. Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies. Leading experts present general principles for the ethical conduct of research on womenâ€principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research. Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research. The book addresses present-day challenges to equity in four areas: Scientificâ€Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics. Social and Ethicalâ€The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants. Legalâ€Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases. Riskâ€The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed. This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals. |
| citi good clinical practice course: Class Paul Fussell, 1992 This book describes the living-room artifacts, clothing styles, and intellectual proclivities of American classes from top to bottom. |
| citi good clinical practice course: Code of Ethics for Nurses with Interpretive Statements American Nurses Association, 2001 Pamphlet is a succinct statement of the ethical obligations and duties of individuals who enter the nursing profession, the profession's nonnegotiable ethical standard, and an expression of nursing's own understanding of its commitment to society. Provides a framework for nurses to use in ethical analysis and decision-making. |
| citi good clinical practice course: Handbook for Good Clinical Research Practice (GCP) World Health Organization, 2005 |
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