Download or read book Principles of Research Methodology written by Phyllis G. Supino and published by Springer Science & Business Media. This book was released on 2012-06-22 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Oxford Handbook of Clinical and Laboratory Investigation written by Drew Provan and published by Oxford University Press. This book was released on 2018 with total page 1007 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook provides an authoritative guide to investigation and diagnosis. It describes key symptoms and signs, alongside appropriate tests, and highlights pitfalls in interpreting results. It also describes a clear, rational method of investigation in order to aid quick and efficient diagnosis, and prevent over-investigation of patients.

Download or read book Oxford Handbook of Clinical and Laboratory Investigation written by Drew Provan and published by OUP Oxford. This book was released on 2010-07-15 with total page 829 pages. Available in PDF, EPUB and Kindle. Book excerpt: Modern medicine is highly complex and investigations are a key part of the diagnostic process. With major advances in technology there are thousands of clinical and laboratory tests available. This book provides a patient-oriented approach to investigation. The first chapter describes key symptoms and signs along with tests that may be of value in reaching a diagnosis. The remainder of the book is specialty-centred and provides a comprehensive review of all available tests within a given subject. The aim is of the book is to provide a more rational method of investigation and prevent over-investigation which is expensive for the hospital and unpleasant for the patient. It emphasises which tests are of value, when tests are not likely to be helpful, along with pitfalls in the interpretation of results. This new edition has been updated throughout to incorporate current investigations and management of disease. Chapters on rheumatology, radiology, and renal medicine have been extensively revised. With contributions from active clinicians who are engaged in medical practice, the book will be of value to senior medical students facing finals examinations, and junior doctors who are responsible for ordering tests on their patients.

Download or read book FDA Investigations Operations Manual written by Food and Drug Administration and published by . This book was released on 2003 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.

Download or read book Clinical Trials Audit Preparation written by Vera Mihajlovic-Madzarevic and published by John Wiley & Sons. This book was released on 2010-09-29 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development

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.

Download or read book Principles and Practice of Clinical Research written by John I. Gallin and published by Elsevier. This book was released on 2011-04-28 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book A Clinical Trials Manual From The Duke Clinical Research Institute written by Margaret Liu and published by John Wiley & Sons. This book was released on 2011-08-24 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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.

Download or read book Handbook for Clinical Investigators written by Christopher Kirkpatrick and published by CRC Press. This book was released on 2002-09-11 with total page 85 pages. Available in PDF, EPUB and Kindle. Book excerpt: This text is aimed at potential clinical investigators usually physicians, especialy those thinking about doing clinical trials to evaluate new drugs - mostly sponsored by pharmaceutical companies.

Download or read book Dose Finding Designs for Early Phase Cancer Clinical Trials written by Takashi Daimon and published by Springer. This book was released on 2019-05-21 with total page 146 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive introduction to statistical methods for designing early phase dose-finding clinical trials. It will serve as a textbook or handbook for graduate students and practitioners in biostatistics and clinical investigators who are involved in designing, conducting, monitoring, and analyzing dose-finding trials. The book will also provide an overview of advanced topics and discussions in this field for the benefit of researchers in biostatistics and statistical science. Beginning with backgrounds and fundamental notions on dose finding in early phase clinical trials, the book then provides traditional and recent dose-finding designs of phase I trials for, e.g., cytotoxic agents in oncology, to evaluate toxicity outcome. Included are rule-based and model-based designs, such as 3 + 3 designs, accelerated titration designs, toxicity probability interval designs, continual reassessment method and related designs, and escalation overdose control designs. This book also covers more complex and updated dose-finding designs of phase I-II and I/II trials for cytotoxic agents, and cytostatic agents, focusing on both toxicity and efficacy outcomes, such as designs with covariates and drug combinations, maximum tolerated dose-schedule finding designs, and so on.

Download or read book Fundamentals of Clinical Trials written by Lawrence M. Friedman and published by Springer Science & Business Media. This book was released on 1998 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.

Download or read book Principles and Practice of Clinical Trials written by Steven Piantadosi and published by Springer Nature. This book was released on 2022-07-19 with total page 2573 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

Download or read book Oxford Handbook of Clinical and Healthcare Research written by Sumantra Ray and published by Oxford University Press. This book was released on 2016 with total page 603 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is a definitive, up-to-date, and succinct text covering the legislative requirements, scientific foundations, and clinical good practice necessary for clinical, academic, and healthcare research.

Download or read book The CRC s Guide to Coordinating Clinical Research written by Karen E. Woodin and published by CenterWatch. This book was released on 2004 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guidebook is filled with valuable information on the role and responsibilities of a clinical research coordinator (CRC) and explains the research process from the site and CRC perspective. Topics covered include: identifying the regulations governing clinical research; describing the drug development process; discussing good clinical practices and how to apply them in clinical trials and organizing a clinical practice.

Download or read book Clinical Handbook of Mindfulness written by Fabrizio Didonna and published by Springer Science & Business Media. This book was released on 2008-12-04 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the last two decades, Eastern psychology has provided fertile ground for therapists, as a cornerstone, a component, or an adjunct of their work. In particular, research studies are identifying the Buddhist practice of mindfulness—a non-judgmental self-observation that promotes personal awareness—as a basis for effective interventions for a variety of disorders. The Clinical Handbook of Mindfulness is a clearly written, theory-to-practice guide to this powerful therapeutic approach (and related concepts in meditation, acceptance, and compassion) and its potential for treating a range of frequently encountered psychological problems. Key features of the Handbook: A neurobiological review of how mindfulness works. Strategies for engaging patients in practicing mindfulness. Tools and techniques for assessing mindfulness. Interventions for high-profile conditions, including depression, anxiety, trauma Special chapters on using mindfulness in oncology and chronic pain. Interventions specific to children and elders, Unique applications to inpatient settings. Issues in professional training. Appendix of exercises. The Clinical Handbook of Mindfulness includes the contributions of some of the most important authors and researchers in the field of mindfulness-based interventions. It will have wide appeal among clinicians, researchers, and scholars in mental health, and its potential for application makes it an excellent reference for students and trainees.

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

Download or read book Scientific Due Diligence written by Nathan Martinsberg and published by Createspace Independent Publishing Platform. This book was released on 2018-05-03 with total page 182 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many a blockbuster drug began in the mind of a single entrepreneur. From start-ups to spin-offs, there are no lack of options for a company or venture capitalist to license or invest into. But how can you know that this is the correct investment? The correct option to choose? The one which will lead to financial success and a nice end-of-year bonus? This is where scientific due diligence comes in, the independent, realistic and critical review of a potential technology. From early development data through to clinical study results, patents to competitor analysis, the due diligence process is essential for any investment decision. We have developed this handbook to guide investors and due diligence investigators through the minefield of scientific due diligence in the pharmaceutical world. It covers best-practice approaches, traps to avoid, and the most important areas to focus your limited time on. Investing in pharma? Then this is the book for you. --- Book contents --- The book has been divided into sections which cover the entire due diligence process. The first section covers the basics of due diligence: - Chapter 1 introduces due diligence investigations, including the attributes of good due diligence investigators, the basic rules to follow, and commonly-seen licensing approaches. - Chapter 2 covers the initial steps of assessment, including the preliminary screening for potential licenses and the secondary screen to identify true opportunities. - Chapter 3 shows the preparation for the on-site scientific due diligence investigation, including typical organisational tasks and team set-up. Next, the specific requirements for each area of expertise are covered in more depth: - Chapter 4 covers the investigation from the regulatory affairs perspective, including factors such as approval risk, regulatory planning, and useful special pathways. - Chapter 5 deals with quality, the assurance that the technology has been developed and manufactured to the required quality levels. The chapter covers typical GMP documents and important GxP requirements which will need to be verified. - Chapter 6 covers chemistry, manufacturing and control, the details of the product and the production process. This includes manufacturing-site specific documents and the process development and validation requirements. - Chapter 7 describes preclinical trials, the preliminary work prior to human testing. This includes approaches for evaluating preclinical studies as well as more specific information for toxicology and pharmacology work. - Chapter 8 involves clinical trials, the most important test of any new drug. This section covers both general trial requirements as well as those specific to individual clinical phases. - Chapter 9 deals with marketing, the ability to sell the new product. This includes determining market position, analysing potential competitors, and determining reimbursement options. - Chapter 10 describes the intellectual property factors which may be involved, covering both patenting and data exclusivity approaches to IP protection. - Chapter 11 finishes the scientific due diligence process by providing the final set of questions to ask prior to making the final recommendation. Finally the five appendices provide reference information which will help when conducting a due diligence investigation, from example checklists to work from through to advice for when you are being audited.