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| clinical study report template word: Sharing Clinical Trial Data Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Responsible Sharing of Clinical Trial Data, 2015-04-20 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. |
| clinical study report template word: Veterinary Clinical Trials From Concept to Completion Nigel Dent, Ramzan Visanji, 2001-12-31 Conceived and edited by Nigel Dent and Ramzan Visanji, Veterinary Clinical Trials form Concept to Completion is designed for both established practitioners and novices, offering alternative ways of conducting studies and ensuring that the studies are guided by Good Clinical Practices and are in compliance with regulations. Comprehensive in scope, it provides the scientific, biological, and regulatory background invaluable to teachers, researchers, and regulatory affairs staff, as well as those directly involved in clinical trials. The book covers: Objectives of the clinical study Control of the study Conduct of the study Regulation versus compliance Factors for success International harmonization activities Roles of the investigator, the monitor, and the practicing veterinarian Setting up GCP trials with particular animal species SOPs, the generic protocol, and the study report Contract research farms and multi-site studies Auditing With contributions from experts in every area of veterinary trials, the text has been organized with everyday use in mind. The chapters can be read sequentially for a comprehensive view or individually for coverage of particular topics and issues as needed. Drawing directly from the in-the-trenches experience of the editors and chapter authors, the book is a guide to methods that ensure studies meet regulatory compliance and strategies that ensure avoidance of common pitfalls. |
| clinical study report template word: Clinical Trial Project Management Ashok Kumar Peepliwal, 2023-11-15 Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials, in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing etc. covering entire clinical trial process of conductance. In addition to that the author also incorporated the clinical trial approval process of USFDA, EMA, and JAPAN to conduct the clinical trials. Covers how to conduct clinical trials in detail Present useful, basic, and advanced statistical tools Provides real-time project management methods like Program Evaluation Review Technique (PERT) and Critical Path Method (CPM) to manage complex projects are described in the book |
| clinical study report template word: Good Laboratory Practice Jürg P. Seiler, 2006-01-16 After more than twenty years of use Good Laboratory Practice, or GLP, has attained a secure place in the world of testing chemicals and other “test items” with regard to their safety for humans and the environment. Gone are the days when the GLP regulations were hotly debated amongst scientists in academia and industry and were accused of stifling flexibility in, imaginative approaches to, and science-based conduct of, all kinds of studies concerned with toxic effects and other parameters important for the evaluation and assessment of products submitted for registration and permission to market. The GLP regulations have developed from rules on how to exactly document the planning, conduct and reporting of toxicity studies to a quality system for the management of a multitude of study types, from the simple determination of a physical/chemical parameter to the most complex field studies or ecotoxicology studies. At the same time the term “Good Laboratory Practice” has become somewhat of a slogan with the aim to characterise any reliably conducted laboratory work. |
| clinical study report template word: The Uterus T. Chard, Jurgis Gediminas Grudzinskas, 1994-11-17 The series provides an essential source of information for all trainees in obstetrics, gynaecology, andrology and reproductive medicine, and will also be of interest to reproductive biologists and geneticists, physiologists and endocrinologists. |
| clinical study report template word: Clinical Trials Audit Preparation Vera Mihajlovic-Madzarevic, 2010-09-29 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 |
| clinical study report template word: Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide Agency for Health Care Research and Quality (U.S.), 2013-02-21 This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov) |
| clinical study report template word: Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs) Joy Frestedt, 2024-09-27 A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices, in compliance with the EU MDR requirements and other similar regulatory requirements throughout the world. This book brings together knowledge learned as the author constructed hundreds of CERs and taught thousands of learners on how to conduct clinical data evaluations. This book will support training for clinical engineers, clinical evaluation scientists, and experts reviewing medical device CERs, and will help individual writers, teams and companies to develop stronger, more robust CERs. Identifies and explains data analysis for clinical evaluation of medical devices Teaches readers how to understand and evaluate medical device performance and safety in the context of new regulations Provides analysis of new clinical evaluation criteria in the context of medical device design as well as in-hospital deployment and servicing |
| clinical study report template word: Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics Linda Fossati Wood, MaryAnn Foote, 2009-01-05 This book describes the authors’ standard or ‘best’ practices used in writing regul- ed clinical documents for the drug and biologics industry. The fundamental premise of this book is that the end (documents submitted to a health authority) is dep- dent on the beginning (the planning and strategy that go into organizing written documentation). Each regulatory document inherently exists within a constellation of related documents. This book attempts to show the relationships between and among these documents and suggests strategies for organizing and writing these documents to maximize ef?ciency while developing clear and concise text. At all times, and irrespective of applicable laws and guidelines, good communication skills and a sense of balance are essential to adequately, accurately, and clearly describe a product’s characteristics. At no time should the reader perceive these suggestions to be the only viable solution to writing regulatory documents nor should the reader expect that these suggestions guarantee product success. The audience for this book is the novice medical writer, or those who would like to explore or enhance regulatory-writing skills. We assume the reader will have a basic understanding of written communication, but little experience in applying this skill to the task of regulatory writing. Extensive knowledge of science, clinical me- cine, mathematics, or regulatory affairs law is not required to use the best practices described in this book. |
| clinical study report template word: Phonological Templates in Development Marilyn May Vihman, 2019-10-30 This book explores the role of phonological templates in early language use from the perspective of usage-based phonology and exemplar models and within the larger developmental framework of Dynamic Systems Theory. After analysing children's first words and their adult targets, Vihman sets out procedures for establishing the children's later prosodic structures and templates, drawing on data from American and British English, Estonian, Finnish, French, Italian, and Welsh; she also provides briefer longitudinal accounts of template use in Arabic and Brazilian Portuguese. The children are found to begin with simple word forms that match their selected adult targets; this is followed by the production of more challenging words, adapted to fit the child's existing patterns. Early accuracy is replaced by later recourse to an 'inner model'--a template--of a favoured word shape. The book also examines the timing, fading, quantification, and function of child phonological templates. In addition, two chapters focus on the use of templates in adult language, in the core grammar and in the more creative morphology of colloquial 'short forms' and hypocoristics in French and Estonian and of English rhyming compounds. The idea of templates is traced back to its origins in Prosodic Morphology, but its uses are most in evidence in the informal settings of adult language 'at play'. Throughout the volume, the discussion returns to the issues of emergent systematicity, the roles of articulatory and memory challenges for children, and the similarities and differences in the function of templates for adults as compared with children. |
| clinical study report template word: Clinical Evaluation of Medical Devices Karen M. Becker, John J. Whyte, 2007-11-05 The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs. |
| clinical study report template word: International Ethical Guidelines for Biomedical Research Involving Human Subjects Council for International Organizations of Medical Sciences, 2002 The present text is the revised/updated version of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. It consists of 21 guidelines with commentaries. A prefatory section outlines the historical background and the revision process and includes an introduction an account of earlier instruments and guidelines a statement of ethical principles and a preamble. An Appendix lists the items to be included in the research protocol to be submitted for scientific and ethical review and clearance. The Guidelines relate mainly to ethical justification and scientific validity of research; ethical review; informed consent; vulnerability - of individuals groups communities and populations; women as research subjects; equity regarding burdens and benefits; choice of control in clinical trials; confidentiality; compensation for injury; strengthening of national or local capacity for ethical review; and obligations of sponsors to provide health-care services. They are designed to be of use to countries in defining national policies on the ethics of biomedical research involving human subjects applying ethical standards in local circumstances and establishing or improving ethical review mechanisms. A particular aim is to reflect the conditions and the needs of low-resource countries and the implications for multinational or transnational research in which they may be partners. |
| clinical study report template word: Cochrane Handbook for Systematic Reviews of Interventions Julian P. T. Higgins, Sally Green, 2008-11-24 Healthcare providers, consumers, researchers and policy makers are inundated with unmanageable amounts of information, including evidence from healthcare research. It has become impossible for all to have the time and resources to find, appraise and interpret this evidence and incorporate it into healthcare decisions. Cochrane Reviews respond to this challenge by identifying, appraising and synthesizing research-based evidence and presenting it in a standardized format, published in The Cochrane Library (www.thecochranelibrary.com). The Cochrane Handbook for Systematic Reviews of Interventions contains methodological guidance for the preparation and maintenance of Cochrane intervention reviews. Written in a clear and accessible format, it is the essential manual for all those preparing, maintaining and reading Cochrane reviews. Many of the principles and methods described here are appropriate for systematic reviews applied to other types of research and to systematic reviews of interventions undertaken by others. It is hoped therefore that this book will be invaluable to all those who want to understand the role of systematic reviews, critically appraise published reviews or perform reviews themselves. |
| clinical study report template word: Registries for Evaluating Patient Outcomes Agency for Healthcare Research and Quality/AHRQ, 2014-04-01 This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. |
| clinical study report template word: New Drug Approval Process Richard A. Guarino, Richard Guarino, 2016-04-19 The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.Updated chapters include:advances in international regulatory requirements, including ICH guidelines and harmonizationa step-by-step |
| clinical study report template word: Principles of Clinical Research Ignazio Di Giovanna, Gareth Hayes, 2001 In an arena which has seen rapid change over the past decade, this work provides a comprehensive and up-to-date guide to the planning, organization and management of clinical trials. |
| clinical study report template word: Applied Statistical Considerations for Clinical Researchers David Culliford, 2021-11-18 This essential book details intermediate-level statistical methods and frameworks for the clinician and medical researcher with an elementary grasp of health statistics and focuses on selecting the appropriate statistical method for many scenarios. Detailed evaluation of various methodologies familiarizes readers with the available techniques and equips them with the tools to select the best from a range of options. The inclusion of a hypothetical case study between a clinician and statistician charting the conception of the research idea through to results dissemination enables the reader to understand how to apply the concepts covered into their day-to-day clinical practice. Applied Statistical Considerations for Clinical Researchers focuses on how clinicians can approach statistical issues when confronted with a medical research problem by considering the data structure, how this relates to their study's aims and any potential knock-on effects relating to the evidence required to make correct clinical decisions. It covers the application of intermediate-level techniques in health statistics making it an ideal resource for the clinician seeking an up-to-date resource on the topic. |
| clinical study report template word: Human Medical Thermography James Stewart Campbell, M. Nathaniel Mead, 2022-08-05 Want to incorporate medical infrared imaging into your practice but can’t find a book that explains how to do it? Well, this book is for you! Complete, practical instructions are provided on imager choice and care as well as the physical needs of a thermography service from the imaging room layout to the computer requirements. How to acquire, interpret, and report a thermal examination is covered in detail. Fully illustrated with both normal and abnormal images, Human Medical Thermography provides practitioners of all types with the knowledge to design and operate a scientifically based thermography practice. Key Features • Shows how to select the best thermal imager for your clinical practice, care for it, and use it correctly. • Explains how to take medical quality thermal images and scale them for maximum visual effect using the guidelines detailed in this book. • Details myriad ways that thermography can aid in medical diagnosis and improve surgical outcomes. |
| clinical study report template word: Student Workbook for Anatomy of Writing for Publication for Nurses, Fifth Edition Cynthia Saver, 2024-05-23 This student workbook for Anatomy of Writing for Publication for Nurses, Fifth Edition, provides students with multiple practice opportunities to build excellent writing skills. Each chapter of the student workbook summarizes that chapter’s material in the main book and includes relevant learning activities so that students can maximize their writing skill set. If you need to make the leap from single sentences to a published manuscript, you will find valuable help and resources in the fully updated fifth edition of Anatomy of Writing for Publication for Nurses. Lead author and editor Cynthia Saver, along with 25 of nursing’s top writing experts and decision-makers, share important insights to help you craft a quality manuscript and get it accepted for publication. The book includes instruction on how to write clinical articles, research reports, review articles, nursing narratives, peer reviews, book chapters, and much more, as well as an overview of the publication process. |
| clinical study report template word: Advanced Methods in Family Therapy Research Richard B Miller, Lee N. Johnson, 2013-12-17 Research is vital in moving the field of family therapy forward, but the myriad of possibilities inherent in working with systems and individuals can overwhelm even the most seasoned researcher. Advanced Methods in Family Therapy Research is the best resource to address the day-to-day questions that researchers have as they investigate couples and families, and the best source for learning long-term theory and methodology. The contributors of this volume share their wisdom on a wide variety of topics including validity concerns, measuring interpersonal process and relational change, dyadic data analysis (demonstrated through a sample research study), mixed methods studies, and recruitment and retention. The volume contains one of the most detailed descriptions of data collections and covers interviewing, using questionnaires, and observing brain activity. Also addressed are suggestions to meaningfully reduce cultural bias, to conduct ethical research, and, in the Health Services Research chapter, to examine interventions for clients in various income brackets. A separate, ground-breaking chapter also addresses psychophysiological research in a couple and family therapeutic context. As an added benefit, readers will learn how to become informed consumers of journal articles and studies, how to produce quality, publishable research, and how to write fundable grant proposals. Each chapter provides a clear and detailed guide for students, researchers, and professionals, and as a whole Advanced Methods in Family Therapy Research advances the field by teaching readers how to provide evidence that marriage and family therapy not only relieves symptoms, but also effects behavioral change in all family members. |
| clinical study report template word: International Ethical Guidelines for Health-Related Research Involving Humans Council for International Organizations of Medical Sciences (CIOMS), 2017-01-31 In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research.--Page 4 de la couverture. |
| clinical study report template word: Care at the Close of Life: Evidence and Experience Stephen J. McPhee, Margaret A. Winker, Michael W. Rabow, Steven Z. Pantilat, Amy J. Markowitz, 2010-10-04 From one of the world’s leading medical journals comes the definitive evidence-based, full-color guide to end-of-life and palliative care ...represents an important milestone in the evolution of care for people with advanced disease—-for which its editors and authors and JAMA should be rightly proud. It is wonderful that JAMA had the foresight to publish a series on this topic, which, as medicine has become more technologically advanced and subspecialized, is often overlooked and, sometimes worse, avoided....this book will be invaluable for front-line clinicians, and indeed all health care practitioners—as care at the close of life is a part of almost all of medicine’s specialties and settings.--Irene J. Higginson, BMBS, PhD, FPPHM, FRCP; Dept. of Palliative Care, Policy, & Rehabilitation; Cicely Saunders Institute; King's College London (from the foreword) A new addition to the JAMAevidence series, Care at the Close of Life: Evidence and Experience offers evidence-based and clinical expert guidance on caring for patients with life-limiting illness, incorporating the words and perspectives of affected patients, their families, and treating clinicians. Organized by these actual clinical cases, the book is based on the acclaimed 7-year series of 42 articles, originally published in JAMA as “Perspectives on Care at the Close of Life,” and now thoroughly updated as chapters and featuring extensive never-before-published material. Care at the Close of Life covers are a wide range of clinical syndromes, disease processes, communication challenges, health-care delivery settings, and issues faced by patients, including withdrawal of dialysis and other life-sustaining measures, cross-cultural approaches, and the role of chemotherapy. Throughout the book, emphasis is on the principles of palliative care, with the patient and family at the center of care, and with attention given to all problems—physical, psychological, social, and spiritual. Reflecting this focus, each chapter begins with a patient case study to introduce the clinical problem, followed by “perspectives” that draw on extensive, real-world dialogue between clinicians, patients, and families. Internationally renowned authors then review the typical challenges illustrated by the case, offering state-of-the-art, evidence-based assessment and treatment approaches. Features Fully revised and updated text with new evidence and references, including the search methodology for each chapter’s update Evidence-based orientation presents the current state of knowledge in the care of terminally ill patients and support for their families and caregivers Practical clinical guidance and approaches from international experts in palliative care Self-assessment Q&A, for reinforcing your knowledge of each chapter’s content and for preparing for exams A useful Glossary of acronyms, terms, and tests Updated Resources for each chapter offer current, authoritative sources of diagnostic and treatment information that can help you optimize palliative care Medline PubMed ID numbers facilitate quick, convenient access to references |
| clinical study report template word: 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. |
| clinical study report template word: Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies OECD, World Health Organization, 2019-10-17 This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies. |
| clinical study report template word: Medical Uses of Statistics John C. Bailar, David C. Hoaglin, 2012-01-10 A new edition of the classic guide to the use of statistics in medicine, featuring examples from articles in the New England Journal of Medicine Medical Uses of Statistics has served as one of the most influential works on the subject for physicians, physicians-in-training, and a myriad of healthcare experts who need a clear idea of the proper application of statistical techniques in clinical studies as well as the implications of their interpretation for clinical practice. This Third Edition maintains the focus on the critical ideas, rather than the mechanics, to give practitioners and students the resources they need to understand the statistical methods they encounter in modern medical literature. Bringing together contributions from more than two dozen distinguished statisticians and medical doctors, this volume stresses the underlying concepts in areas such as randomized trials, survival analysis, genetics, linear regression, meta-analysis, and risk analysis. The Third Edition includes: Numerous examples based on studies taken directly from the pages of the New England Journal of Medicine Two added chapters on statistics in genetics Two new chapters on the application of statistical methods to studies in epidemiology New chapters on analyses of randomized trials, linear regression, categorical data analysis, meta-analysis, subgroup analyses, and risk analysis Updated chapters on statistical thinking, crossover designs, p-values, survival analysis, and reporting research results A focus on helping readers to critically interpret published results of clinical research Medical Uses of Statistics, Third Edition is a valuable resource for researchers and physicians working in any health-related field. It is also an excellent supplemental book for courses on medicine, biostatistics, and clinical research at the upper-undergraduate and graduate levels. You can also visit the New England Journal of Medicine website for related information. |
| clinical study report template word: Suggestions to Medical Authors and A.M.A. Style Book American Medical Association, 1919 |
| clinical study report template word: Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Population Health and Public Health Practice, 2020-04-24 Among the many who serve in the United States Armed Forces and who are deployed to distant locations around the world, myriad health threats are encountered. In addition to those associated with the disruption of their home life and potential for combat, they may face distinctive disease threats that are specific to the locations to which they are deployed. U.S. forces have been deployed many times over the years to areas in which malaria is endemic, including in parts of Afghanistan and Iraq. Department of Defense (DoD) policy requires that antimalarial drugs be issued and regimens adhered to for deployments to malaria-endemic areas. Policies directing which should be used as first and as second-line agents have evolved over time based on new data regarding adverse events or precautions for specific underlying health conditions, areas of deployment, and other operational factors At the request of the Veterans Administration, Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis assesses the scientific evidence regarding the potential for long-term health effects resulting from the use of antimalarial drugs that were approved by FDA or used by U.S. service members for malaria prophylaxis, with a focus on mefloquine, tafenoquine, and other antimalarial drugs that have been used by DoD in the past 25 years. This report offers conclusions based on available evidence regarding associations of persistent or latent adverse events. |
| clinical study report template word: Radiology Business Practice David M. Yousem, Norman J. Beauchamp, 2007-11-19 To succeed in radiology, you not only need to be able to interpret diagnostic images accurately and efficiently; you also need to make wise decisions about managing your practice at every level. Whether you work in a private, group, hospital, and/or university setting, this practical resource delivers the real-world advice you need to effectively navigate day-to-day financial decisions, equipment and computer systems choices, and interactions with your partners and staff. Equips you to make the best possible decisions on assessing your equipment needs · dealing with manufacturers · purchasing versus leasing · and anticipating maintenance costs and depreciation. Helps you to identify your most appropriate options for picture archiving systems and radiology information systems · security issues · high-speed lines · storage issues · workstation assessments · and paperless filmless flow. Offers advice on dealing with departments/clinicians who wish to perform radiological procedures and provides strategies for win-win compromises, drawing the line, inpatient-versus-outpatient considerations, cost and revenue sharing, and more. |
| clinical study report template word: Teaching Biostatistics in Medicine and Allied Health Sciences Damian J. J. Farnell, Renata Medeiros Mirra, 2023-06-16 This book discusses the theory and practice of teaching biostatistics to students in the life sciences, in particular medical and dental trainees and researchers, as well as its crucial importance to biomedical research and evidence-based health care. Specific tools and resources to biostatistics teaching (e.g., “R shiny”) are described, and how they can be used effectively to increase interaction with students and improve engagement with the subject. The book is structured into three parts: teaching and learning of statistics in medicine and allied health sciences; the move to online learning and online learning methods, especially in light of the impact of COVID-19; and computer tools and resources. It provides a unique insight into teaching biostatistics to medical and dental students from some of the most prominent biostatisticians who also have a very strong interest in biostatistics pedagogy. Biostatistics teaching is important for maintaining the quality of biomedical research and also in evidence-based medicine, both of which are key to the health and well-being of the world population. This book is particularly useful to readers who are new to the field of biostatistics teaching as well as to more experienced teachers as it presents the latest accounts of the teaching and learning of biostatistics, recent experiences of increased use of online teaching, and useful computer resources and tools for teaching biostatistics. |
| clinical study report template word: Parenting Matters National Academies of Sciences, Engineering, and Medicine, Division of Behavioral and Social Sciences and Education, Board on Children, Youth, and Families, Committee on Supporting the Parents of Young Children, 2016-12-21 Decades of research have demonstrated that the parent-child dyad and the environment of the familyâ€which includes all primary caregiversâ€are at the foundation of children's well- being and healthy development. From birth, children are learning and rely on parents and the other caregivers in their lives to protect and care for them. The impact of parents may never be greater than during the earliest years of life, when a child's brain is rapidly developing and when nearly all of her or his experiences are created and shaped by parents and the family environment. Parents help children build and refine their knowledge and skills, charting a trajectory for their health and well-being during childhood and beyond. The experience of parenting also impacts parents themselves. For instance, parenting can enrich and give focus to parents' lives; generate stress or calm; and create any number of emotions, including feelings of happiness, sadness, fulfillment, and anger. Parenting of young children today takes place in the context of significant ongoing developments. These include: a rapidly growing body of science on early childhood, increases in funding for programs and services for families, changing demographics of the U.S. population, and greater diversity of family structure. Additionally, parenting is increasingly being shaped by technology and increased access to information about parenting. Parenting Matters identifies parenting knowledge, attitudes, and practices associated with positive developmental outcomes in children ages 0-8; universal/preventive and targeted strategies used in a variety of settings that have been effective with parents of young children and that support the identified knowledge, attitudes, and practices; and barriers to and facilitators for parents' use of practices that lead to healthy child outcomes as well as their participation in effective programs and services. This report makes recommendations directed at an array of stakeholders, for promoting the wide-scale adoption of effective programs and services for parents and on areas that warrant further research to inform policy and practice. It is meant to serve as a roadmap for the future of parenting policy, research, and practice in the United States. |
| clinical study report template word: Bayesian Adaptive Methods for Clinical Trials Scott M. Berry, Bradley P. Carlin, J. Jack Lee, Peter Muller, 2010-07-19 Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer's disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers of Bayesian clinical trial designs, Bayesian Adapti |
| clinical study report template word: Ask a Manager Alison Green, 2018-05-01 'I'm a HUGE fan of Alison Green's Ask a Manager column. This book is even better' Robert Sutton, author of The No Asshole Rule and The Asshole Survival Guide 'Ask A Manager is the book I wish I'd had in my desk drawer when I was starting out (or even, let's be honest, fifteen years in)' - Sarah Knight, New York Times bestselling author of The Life-Changing Magic of Not Giving a F*ck A witty, practical guide to navigating 200 difficult professional conversations Ten years as a workplace advice columnist has taught Alison Green that people avoid awkward conversations in the office because they don't know what to say. Thankfully, Alison does. In this incredibly helpful book, she takes on the tough discussions you may need to have during your career. You'll learn what to say when: · colleagues push their work on you - then take credit for it · you accidentally trash-talk someone in an email and hit 'reply all' · you're being micromanaged - or not being managed at all · your boss seems unhappy with your work · you got too drunk at the Christmas party With sharp, sage advice and candid letters from real-life readers, Ask a Manager will help you successfully navigate the stormy seas of office life. |
| clinical study report template word: Social Isolation and Loneliness in Older Adults National Academies of Sciences, Engineering, and Medicine, Division of Behavioral and Social Sciences and Education, Health and Medicine Division, Board on Behavioral, Cognitive, and Sensory Sciences, Board on Health Sciences Policy, Committee on the Health and Medical Dimensions of Social Isolation and Loneliness in Older Adults, 2020-06-14 Social isolation and loneliness are serious yet underappreciated public health risks that affect a significant portion of the older adult population. Approximately one-quarter of community-dwelling Americans aged 65 and older are considered to be socially isolated, and a significant proportion of adults in the United States report feeling lonely. People who are 50 years of age or older are more likely to experience many of the risk factors that can cause or exacerbate social isolation or loneliness, such as living alone, the loss of family or friends, chronic illness, and sensory impairments. Over a life course, social isolation and loneliness may be episodic or chronic, depending upon an individual's circumstances and perceptions. A substantial body of evidence demonstrates that social isolation presents a major risk for premature mortality, comparable to other risk factors such as high blood pressure, smoking, or obesity. As older adults are particularly high-volume and high-frequency users of the health care system, there is an opportunity for health care professionals to identify, prevent, and mitigate the adverse health impacts of social isolation and loneliness in older adults. Social Isolation and Loneliness in Older Adults summarizes the evidence base and explores how social isolation and loneliness affect health and quality of life in adults aged 50 and older, particularly among low income, underserved, and vulnerable populations. This report makes recommendations specifically for clinical settings of health care to identify those who suffer the resultant negative health impacts of social isolation and loneliness and target interventions to improve their social conditions. Social Isolation and Loneliness in Older Adults considers clinical tools and methodologies, better education and training for the health care workforce, and dissemination and implementation that will be important for translating research into practice, especially as the evidence base for effective interventions continues to flourish. |
| clinical study report template word: Making Eye Health a Population Health Imperative National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Population Health and Public Health Practice, Committee on Public Health Approaches to Reduce Vision Impairment and Promote Eye Health, 2017-01-15 The ability to see deeply affects how human beings perceive and interpret the world around them. For most people, eyesight is part of everyday communication, social activities, educational and professional pursuits, the care of others, and the maintenance of personal health, independence, and mobility. Functioning eyes and vision system can reduce an adult's risk of chronic health conditions, death, falls and injuries, social isolation, depression, and other psychological problems. In children, properly maintained eye and vision health contributes to a child's social development, academic achievement, and better health across the lifespan. The public generally recognizes its reliance on sight and fears its loss, but emphasis on eye and vision health, in general, has not been integrated into daily life to the same extent as other health promotion activities, such as teeth brushing; hand washing; physical and mental exercise; and various injury prevention behaviors. A larger population health approach is needed to engage a wide range of stakeholders in coordinated efforts that can sustain the scope of behavior change. The shaping of socioeconomic environments can eventually lead to new social norms that promote eye and vision health. Making Eye Health a Population Health Imperative: Vision for Tomorrow proposes a new population-centered framework to guide action and coordination among various, and sometimes competing, stakeholders in pursuit of improved eye and vision health and health equity in the United States. Building on the momentum of previous public health efforts, this report also introduces a model for action that highlights different levels of prevention activities across a range of stakeholders and provides specific examples of how population health strategies can be translated into cohesive areas for action at federal, state, and local levels. |
| clinical study report template word: Symptoms in the Pharmacy Alison Blenkinsopp, Paul Paxton, John Blenkinsopp, 2013-03-27 A practical and evidence-based guide for student, pre-registration and qualified pharmacists Symptoms in the Pharmacy is an indispensable guide to the management of common symptoms seen in the pharmacy. With advice from an author team that includes both pharmacists and GPs, the book covers ailments which will be encountered in the pharmacy on a daily basis. Now in its sixth edition Symptoms in the Pharmacy has been fully revised to reflect the latest evidence and availability of new medicines. There are new sections and case studies for 'POM' to 'P' switches including chloramphenicol, sumatriptan, diclofenac, naproxen and amorolfine. This edition features colour photographs of skin conditions for the first time enabling the differentiation and diagnosis of common complaints. The public health and illness prevention content have been expanded to support this increasingly important aspect of the pharmacist’s work. The book is designed for quick and easy reference with separate chapters for each ailment. Each chapter incorporates a decision making framework in which the information necessary for treatment and suggestions on ‘when to refer’ is distilled into helpful summary boxes. At the end of each chapter there are example case studies providing the view of pharmacists, doctors and patients for most conditions covered. These easy-to-follow- chapters can be read cover to cover or turned to for quick reference. This useful guide should be kept close at hand for frequent consultation. |
| clinical study report template word: Air & Light & Time & Space Helen Sword, 2017-04-17 From the author of Stylish Academic Writing comes an essential new guide for writers aspiring to become more productive and take greater pleasure in their craft. Helen Sword interviewed 100 academics worldwide about their writing background and practices and shows how they find or create the conditions to get their writing done. |
| clinical study report template word: Development Safety Update Report (DSUR) Harmonizing the Format and Content for Periodic Safety Report During Clinical Trials World Health Organization, 2006 Regular and timely review appraisal and communication of safety information are critical to risk management during the clinical development of drugs. Whereas the overall goal of a clinical development program is to characterize the benefit-risk relationship of the product in a particular patient population, the risk to individual trial subjects is a critical consideration during product development at a time when the effectiveness of a product is generally uncertain. By conducting an overall appraisal of safety data at regular intervals, risks can be recognized thoughtfully assessed and appropriately communicated to all interested stakeholders to support the safety of clinical trial subjects. Although regulatory authorities currently require the submission of a periodic safety report during the conduct of clinical trials, there are substantial differences in the format content and timing of the different reports. The CIOMS VII Working group is proposing in this new publication an internationally harmonized document namely the Development Safety Update Report (DSUR) that is modeled after the Periodic Safety Update Report (PSUR) for marketed products. It presents the general principles behind the preparation and use of the DSUR and a model DSUR. The model is illustrated with sample fictitious DSURs for a commercial and non-commercial (trial-specific) sponsor. |
| clinical study report template word: Guide for the Care and Use of Laboratory Animals National Research Council, Division on Earth and Life Studies, Institute for Laboratory Animal Research, Committee for the Update of the Guide for the Care and Use of Laboratory Animals, 2011-01-27 A respected resource for decades, the Guide for the Care and Use of Laboratory Animals has been updated by a committee of experts, taking into consideration input from the scientific and laboratory animal communities and the public at large. The Guide incorporates new scientific information on common laboratory animals, including aquatic species, and includes extensive references. It is organized around major components of animal use: Key concepts of animal care and use. The Guide sets the framework for the humane care and use of laboratory animals. Animal care and use program. The Guide discusses the concept of a broad Program of Animal Care and Use, including roles and responsibilities of the Institutional Official, Attending Veterinarian and the Institutional Animal Care and Use Committee. Animal environment, husbandry, and management. A chapter on this topic is now divided into sections on terrestrial and aquatic animals and provides recommendations for housing and environment, husbandry, behavioral and population management, and more. Veterinary care. The Guide discusses veterinary care and the responsibilities of the Attending Veterinarian. It includes recommendations on animal procurement and transportation, preventive medicine (including animal biosecurity), and clinical care and management. The Guide addresses distress and pain recognition and relief, and issues surrounding euthanasia. Physical plant. The Guide identifies design issues, providing construction guidelines for functional areas; considerations such as drainage, vibration and noise control, and environmental monitoring; and specialized facilities for animal housing and research needs. The Guide for the Care and Use of Laboratory Animals provides a framework for the judgments required in the management of animal facilities. This updated and expanded resource of proven value will be important to scientists and researchers, veterinarians, animal care personnel, facilities managers, institutional administrators, policy makers involved in research issues, and animal welfare advocates. |
| clinical study report template word: Current Challenges in Pharmacovigilance World Health Organization, Council for International Organizations of Medical Sciences, Cioms, 2001-01-01 In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals. |
| clinical study report template word: Experimentation with Human Subjects Paul Abraham Freund, 1970 Most of the essays appeared in the spring 1969 issue of Dædalus. |
ClinicalTrials.gov
Study record managers: refer to the Data Element Definitions if submitting registration or results information.
CLINICAL Definition & Meaning - Merriam-Webster
The meaning of CLINICAL is of, relating to, or conducted in or as if in a clinic. How to use clinical in a sentence.
CLINICAL | English meaning - Cambridge Dictionary
CLINICAL definition: 1. used to refer to medical work or teaching that relates to the examination and treatment of ill…. Learn more.
CLINICAL definition and meaning | Collins English Dictionary
Clinical means involving or relating to the direct medical treatment or testing of patients.
Clinical Definition & Meaning | Britannica Dictionary
CLINICAL meaning: 1 : relating to or based on work done with real patients of or relating to the medical treatment that is given to patients in hospitals, clinics, etc.; 2 : requiring treatment as a …
CLINICAL | meaning - Cambridge Learner's Dictionary
CLINICAL definition: 1. relating to medical treatment and tests: 2. only considering facts and not influenced by…. Learn more.
Clinical - definition of clinical by The Free Dictionary
1. pertaining to a clinic. 2. concerned with or based on actual observation and treatment of disease in patients rather than experimentation or theory. 3. dispassionately analytic; …
Clinical - Definition, Meaning & Synonyms | Vocabulary.com
Something that's clinical is based on or connected to the study of patients. Clinical medications have actually been used by real people, not just studied theoretically.
Clinical Definition & Meaning - YourDictionary
Clinical definition: Of, relating to, or connected with a clinic.
Equity Medical | Clinical Research In New York And Kentucky
We pioneer dermatological advancements, collaborating on innovative treatments through research and clinical trials in urban New York City and rural Southern Kentucky.
ClinicalTrials.gov
Study record managers: refer to the Data Element Definitions if submitting registration or results information.
CLINICAL Definition & Meaning - Merriam-Webster
The meaning of CLINICAL is of, relating to, or conducted in or as if in a clinic. How to use clinical in a sentence.
CLINICAL | English meaning - Cambridge Dictionary
CLINICAL definition: 1. used to refer to medical work or teaching that relates to the examination and treatment of ill…. Learn more.
CLINICAL definition and meaning | Collins English Dictionary
Clinical means involving or relating to the direct medical treatment or testing of patients.
Clinical Definition & Meaning | Britannica Dictionary
CLINICAL meaning: 1 : relating to or based on work done with real patients of or relating to the medical treatment that is given to patients in hospitals, clinics, etc.; 2 : requiring treatment as a …
CLINICAL | meaning - Cambridge Learner's Dictionary
CLINICAL definition: 1. relating to medical treatment and tests: 2. only considering facts and not influenced by…. Learn more.
Clinical - definition of clinical by The Free Dictionary
1. pertaining to a clinic. 2. concerned with or based on actual observation and treatment of disease in patients rather than experimentation or theory. 3. dispassionately analytic; unemotionally …
Clinical - Definition, Meaning & Synonyms | Vocabulary.com
Something that's clinical is based on or connected to the study of patients. Clinical medications have actually been used by real people, not just studied theoretically.
Clinical Definition & Meaning - YourDictionary
Clinical definition: Of, relating to, or connected with a clinic.
Equity Medical | Clinical Research In New York And Kentucky
We pioneer dermatological advancements, collaborating on innovative treatments through research and clinical trials in urban New York City and rural Southern Kentucky.
