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| electronic data capture training: 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 |
| electronic data capture training: 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. |
| electronic data capture training: Open Electronic Data Capture Tools for Medical and Biomedical Research and Medical Allied Professionals Ashish Pundhir, Amit Kumar Mehto, Abhishek Jaiswal, 2024-03-21 Open Electronic Data Capture Tools for Medical and Biomedical Research and Medical Allied Professionals explains the step-by-step of collecting and treating research data in a didactic manner. The book discusses four freely available data capture tools whose common feature is data collection and entry being done simultaneously rather than separately, thus saving resources and minimizing potential errors. It highlights the comparative features of each data capture tool, helping readers to understand the advantage and disadvantage of each one to decide which tool can be used to fulfill their needs.This is a valuable resource for researchers, students, and members of the biomedical and medical fields who need to learn more about data mining and management to improve the quality of their research work. - Explains how to use open electronic data capture tools to collect and treat research data - Describes step-by-step how to use these tools with practical examples in illustrative manner by using screenshots, tables, and flow charts for easy understanding - Presents the content in a didactic manner to facilitate real-world applicability for any research need |
| electronic data capture training: Capturing and Reporting Electronic Data Willa Y. Garner, Rodney M. Bennett, Markus Jensen, 2002 This volume reviews current data collection systems, examines unique approaches to data collection and storage, and provides the latest information on regulatory issues on data capture, storage, and reporting. |
| electronic data capture training: Practical Guide to Clinical Data Management Susanne Prokscha, 2011-10-26 The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then, |
| electronic data capture training: The Data Book Meredith Zozus, 2017-07-12 The Data Book: Collection and Management of Research Data is the first practical book written for researchers and research team members covering how to collect and manage data for research. The book covers basic types of data and fundamentals of how data grow, move and change over time. Focusing on pre-publication data collection and handling, the text illustrates use of these key concepts to match data collection and management methods to a particular study, in essence, making good decisions about data. The first section of the book defines data, introduces fundamental types of data that bear on methodology to collect and manage them, and covers data management planning and research reproducibility. The second section covers basic principles of and options for data collection and processing emphasizing error resistance and traceability. The third section focuses on managing the data collection and processing stages of research such that quality is consistent and ultimately capable of supporting conclusions drawn from data. The final section of the book covers principles of data security, sharing, and archival. This book will help graduate students and researchers systematically identify and implement appropriate data collection and handling methods. |
| electronic data capture training: 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. |
| electronic data capture training: The Science of Real-Time Data Capture Arthur Stone, 2007-04-19 The National Cancer Institute (NCI) has designated the topic of real-time data capture as an important and innovative research area. As such, the NCI sponsored a national meeting of distinguished research scientists to discuss the state of the science in this emerging and burgeoning field. This book reflects the findings of the conference and discusses the state of the science of real-time data capture and its application to health and cancer research. It provides a conceptual framework for minute-by-minute data capture- ecological momentary assessments (EMA)- and discusses health-related topics where these assessements have been applied. In addition, future directions in real-time data capture assessment, interventions, methodology, and technology are discussed.Despite the rapidly growing interest in the methodology of real-time data capture (e.g. journal special issues, widely attended conference presentations, etc.), to date no single book has focused solely on this topic. The volume will serve as an important resource for researchers, students, and government scientists interested in pursuing real-time health research, and will nicely complement our lists in epidemiology, public health, and oncology. |
| electronic data capture training: WHO Recommendations World Health Organization, 2018 The primary goal of this guideline is to provide a foundation for the implementation of interventions shown to have been effective in reducing the burden of PPH (postpartum haemorrhage). Health professionals responsible for developing national and local health policies constitute the main target audience of this document. Obstetricians, midwives, general medical practitioners, health care managers and public health policy-makers, particularly in under-resourced settings are also targeted. This document establishes general principles of PPH care and it is intended to inform the development of clinical protocols and health policies related to PPH. |
| electronic data capture training: Global Clinical Trials Playbook Menghis Bairu, Richard Chin, 2012-04-20 Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in neglected diseases and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios |
| electronic data capture training: Good Clinical, Laboratory and Manufacturing Practices Philip Carson, Nigel Dent, 2007-10-31 Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included. |
| electronic data capture training: 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. |
| electronic data capture training: Practical Guide to Clinical Data Management, Third Edition Susanne Prokscha, 2011-10-26 The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then, the third edition of Practical Guide to Clinical Data Management includes important updates to all chapters to reflect the current industry approach to using electronic data capture (EDC) for most studies. See what’s new in the Third Edition: A chapter on the clinical trial process that explains the high level flow of a clinical trial from creation of the protocol through the study lock and provides the context for the clinical data management activities that follow Reorganized content reflects an industry trend that divides training and standard operating procedures for clinical data management into the categories of study startup, study conduct, and study closeout Coverage of current industry and Food and Drug Administration (FDA) approaches and concerns The book provides a comprehensive overview of the tasks involved in clinical data management and the computer systems used to perform those tasks. It also details the context of regulations that guide how those systems are used and how those regulations are applied to their installation and maintenance. Keeping the coverage practical rather than academic, the author hones in on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview or introduction for clinical data managers. |
| electronic data capture training: Principles and Practice of Emergency Research Response Robert A. Sorenson, |
| electronic data capture training: Transitiion to Online Testing Society for the Advancement of Excellence in Education, 2007 |
| electronic data capture training: Advance Concepts of Clinical Research Guidance for Industry Dr. Gayatri Ganu, Book is useful for the industrial experts who engage in clinical trials, also for students and research scholar who come in contact with clinical terms. |
| electronic data capture training: Principles and Practice of Clinical Trials Steven Piantadosi, Curtis L. Meinert, 2022-07-19 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. |
| electronic data capture training: Management of Data in Clinical Trials Eleanor McFadden, 2007-12-14 A valuable new edition of the trusted, practical guide to managing data in clinical trials Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided. While maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements. Newly featured topics include: The growing availability of off-the-shelf solutions for clinical trials Potential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industry The increasing use of the Internet in the collection of data and management of trials Regulatory requirements worldwide and compliance with the ICH Good Clinical Practice (GCP) Guidelines Development of Standard Operating Procedures for the conduct of clinical trials Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels. |
| electronic data capture training: Department of Transportation and Related Agencies Appropriations for 2002 United States. Congress. House. Committee on Appropriations. Subcommittee on Department of Transportation and Related Agencies Appropriations, 2002 |
| electronic data capture training: Master protocol for surveillance of pfhrp2/3 deletions and biobanking to support future research World Health Organization, 2020-03-24 Rapid diagnostic test (RDT) kits offer great potential for the immediate diagnosis of malaria infections. Rapid diagnosis allows for prompt treatment, especially in rural settings. Histidine rich protein 2 (HRP2) is an abundant protein expressed only by P. falciparum and is the target for the most commonly used RDTs. While HRP2 RDTs generally have the highest sensitivity of the RDTs for P. falciparum malaria, parasite strains in several countries have been identified that have deletions in the genes encoding HRP2 or the similar HRP3 protein. The purpose of this document is to present an updated standardized protocol that P. falciparum-endemic countries can use to determine the prevalence of parasites with pfhrp2/3 gene deletions causing negative HRP2 RDT results among symptomatic falciparum patients. Two versions are available which allow for a surveillance-only approach or a surveillance combined with biobanking for future research approach. |
| electronic data capture training: COVID-19 and Pandemic Preparedness: Lessons Learned and Next Steps, An Issue of Nursing Clinics, E-Book Kelly A. Wolgast, 2023-02-06 In this issue of Nursing Clinics of North America, guest editor and Director of the COVID-19 Operations Control Center at Penn State College of Nursing Dr. Kelly A. Wolgast brings her considerable expertise to the topic of COVID-19 and Pandemic Preparedness: Lessons Learned and Next Steps Nurses have had to adapt and innovate in the clinical, leadership, technology, research, and academic environments to withstand the impacts of COVID-19, all while innovating new strategies to ensure that quality patient care remains the priority. This issue reflects the work and outcomes that stemmed from necessity by nurses and other health care partners to respond to the needs of patients during this extraordinary and challenging time in history. - Contains 14 practice-oriented topics including reaching the public with vaccination; long-term care and pandemic lessons learned; diversity impacts of COVID-19; clinical nursing during a pandemic: lessons learned; technology in the clinical setting for nurses: what worked and didn't work in the pandemic; and more. - Provides in-depth clinical reviews on COVID-19 and pandemic preparedness, offering actionable insights for clinical practice. - Presents the latest information on this timely, focused topic under the leadership of experienced editors in the field. Authors synthesize and distill the latest research and practice guidelines to create clinically significant, topic-based reviews. |
| electronic data capture training: Department of Transportation and Related Agencies Appropriations for 2002: Department of Transportation ... pt. 6. Airline delays and aviation system capacity ... pt. 7. Testimony of members of Congress and public witnesses United States. Congress. House. Committee on Appropriations. Subcommittee on Department of Transportation and Related Agencies Appropriations, 2001 |
| electronic data capture training: Challenges For Diagnosis, Treatment And Elimination Of Malaria Gisely Melo, Tais Nobrega De Sousa, Manuela Berto Pucca, Giselle Maria Rachid Viana, 2024-04-26 Malaria is a major cause of death in tropical and sub-tropical countries presenting about 627,000 deaths and 241 million cases in the world. Malaria is still an important public health problem that needs to be more effectively controlled. Delays in diagnosis and treatment are responsible for the most deaths in many countries. Moreover, in most of malaria-endemic countries, the lack of resources is a huge barrier to reliable and timely diagnosis. |
| electronic data capture training: Digitalization of Medicine in Low- and Middle-Income Countries Zisis Kozlakidis, |
| electronic data capture training: Official Gazette of the United States Patent and Trademark Office , 2002 |
| electronic data capture training: Clinical and Translational Science David Robertson, Gordon H. Williams, 2009-03-02 Clinical or translational science is the field of study devoted to investigating human health and disease, interventions and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health. New molecular tools and diagnostic technologies based on clinical and translational research have lead to a better understanding of human disease and the application of new therapeutics for enhanced health. Clinical and Translational Science is designed as the most authoritative and modern resource for the broad range of investigators in various medical specialties taking on the challenge of clinical research. Prepared with an international perspective, this resource begins with experimental design and investigative tools to set the scene for readers. It then moves on to human genetics and pharmacology with a focus on statistics, epidemiology, genomic information, drug discovery and development, and clinical trials. Finally, it turns to legal, social, and ethical issues of clinical research concluding with a discussion of future prospects to provide readers with a comprehensive view of the this developing area of science. - Clinical research is one of the fastest growing fields in private practice and academic medicine with practical biological, physiological, cellular, and therapeutic applications - Contributions from international leaders provide insight into background and future understanding for clinical and translational science - Provides the structure for complete instruction and guidance on the subject from fundamental principles, approaches and infrastructure to human genetics, human pharmacology, research in special populations, the societal context of human research, and the future of human research |
| electronic data capture training: Fundamentals of Biologicals Regulation Rebecca Sheets, 2017-12-01 Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. With numerous case studies, learning activities, and real-world examples across several classes of biotechnological products, this book is a valuable and comprehensive resource for graduate students, professors, regulatory officials, and industry scientists working with biologicals. - Provides a broad overview and introduction to the regulatory processes, from product development pathways, through clinical trials and product development stages and beyond - Includes FDA, EMA, ICH, and WHO recommendations and guidelines so readers can compare and contrast the different regulatory regions with their expectations and understand why they are different - Contains chapters on some of the exceptions to the process including how biosimilars and in vitro diagnostics are regulated - Includes numerous case studies, learning activities, and real-world examples across several classes of biotechnological products |
| electronic data capture training: Handbook of Pain Assessment, Third Edition Dennis C. Turk, Ronald Melzack, 2011-08-08 This definitive clinical reference comprehensively reviews the most advanced methods for assessing the person in pain. The field's leading authorities present essential information and tools for evaluating psychosocial, behavioral, situational, and medical factors in patients' subjective experience, functional impairment, and response to treatment. Empirically supported instruments and procedures are detailed, including self-report measures, observational techniques, psychophysiological measures, and more. Best-practice recommendations are provided for assessing the most prevalent pain syndromes and for working with children, older adults, and people with communication difficulties. The book also weighs in on the limitations of existing methods and identifies key directions for future research. |
| electronic data capture training: Good Clinical, Laboratory and Manufacturing Practices Phillip A. Carson, Nigel J. Dent, 2007 Provides practical advice for the quality assurance professional responsible for monitoring compliance with legal requirements and accepted standards of preclinical safety studies, clinical trials and manufacture of drugs. This book also offers a framework for integrating these standards with other quality management systems. |
| electronic data capture training: Writing and Managing SOPs for GCP Susanne Prokscha, 2015-07-29 This book discusses managing SOPs for GCP from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user's point of view to keep topics focused on the practical aspects of SOPs and SOP management. |
| electronic data capture training: Aspects of the Computer-based Patient Record Harold P. Lehmann, Patricia A. Abbott, Nancy K. Roderer, Adam Rothschild, Steven Mandell, Jorge Ferrer, Robert E. Miller, Marion J. Ball, 2013-06-29 One of the hottest political issues today concerns ways to improve national healthcare systems without incurring further costs. An extensive study by the Institute of Medicine (IOM) in the United States formally reported that computer-based patient records are absolutely necessary to help contain the cost explosion in health care. The information obtained from experts, the studies conducted, and the conclusions that went into the IOM's report have now been collected in Aspects of the Computer-Based Patient Record. A large portion of the volume discusses the state-of-the-art in existing computer-based systems as well as the essential needs which must be addressed by future computer-based patients' records. A final section in the book discusses implementation strategies for changing to the electronic system and practical issues: Who will bear the final cost? How and when will healthcare providers who use the system be trained? This volume contains the concise, valuable information which hospital administrators, hospital systems designers, third-party payer groups, and medical technology providers will need if they hope to successfully transit to hospital systems which use a computer-based patient record. |
| electronic data capture training: Global Clinical Trials Richard Chin, Menghis Bairu, 2011-05-06 This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. - Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries - Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting - Case studies outline successes, failures, lessons learned and prospects for future collaboration - Includes country-specific guidelines for the most utilized countries - Foreword by David Feigel, former Head of CDRH at FDA |
| electronic data capture training: MEDINFO 2019: Health and Wellbeing e-Networks for All L. Ohno-Machado, B. Séroussi, 2019-11-12 Combining and integrating cross-institutional data remains a challenge for both researchers and those involved in patient care. Patient-generated data can contribute precious information to healthcare professionals by enabling monitoring under normal life conditions and also helping patients play a more active role in their own care. This book presents the proceedings of MEDINFO 2019, the 17th World Congress on Medical and Health Informatics, held in Lyon, France, from 25 to 30 August 2019. The theme of this year’s conference was ‘Health and Wellbeing: E-Networks for All’, stressing the increasing importance of networks in healthcare on the one hand, and the patient-centered perspective on the other. Over 1100 manuscripts were submitted to the conference and, after a thorough review process by at least three reviewers and assessment by a scientific program committee member, 285 papers and 296 posters were accepted, together with 47 podium abstracts, 7 demonstrations, 45 panels, 21 workshops and 9 tutorials. All accepted paper and poster contributions are included in these proceedings. The papers are grouped under four thematic tracks: interpreting health and biomedical data, supporting care delivery, enabling precision medicine and public health, and the human element in medical informatics. The posters are divided into the same four groups. The book presents an overview of state-of-the-art informatics projects from multiple regions of the world; it will be of interest to anyone working in the field of medical informatics. |
| electronic data capture training: 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. |
| electronic data capture training: Machine Learning for Non/Less-Invasive Methods in Health Informatics Kun Qian, Liang Zhang, Kezhi Li, Juan Liu, 2021-11-26 |
| electronic data capture training: 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. |
| electronic data capture training: Designing and Conducting Business Surveys Ger Snijkers, Gustav Haraldsen, Jacqui Jones, Diane Willimack, 2013-07-01 Designing and Conducting Business Surveys provides a coherent overview of the business survey process, from start to finish. It uniquely integrates an understanding of how businesses operate, a total survey error approach to data quality that focuses specifically on business surveys, and sound project management principles. The book brings together what is currently known about planning, designing, and conducting business surveys, with producing and disseminating statistics or other research results from the collected data. This knowledge draws upon a variety of disciplines such as survey methodology, organizational sciences, sociology, psychology, and statistical methods. The contents of the book formulate a comprehensive guide to scholarly material previously dispersed among books, journal articles, and conference papers. This book provides guidelines that will help the reader make educated trade-off decisions that minimize survey errors, costs, and response burden, while being attentive to survey data quality. Major topics include: • Determining the survey content, considering user needs, the business context, and total survey quality • Planning the survey as a project • Sampling frames, procedures, and methods • Questionnaire design and testing for self-administered paper, web, and mixed-mode surveys • Survey communication design to obtain responses and facilitate the business response process • Conducting and managing the survey using paradata and project management tools • Data processing, including capture, editing, and imputation, and dissemination of statistical outputs Designing and Conducting Business Surveys is an indispensable resource for anyone involved in designing and/or conducting business or organizational surveys at statistical institutes, central banks, survey organizations, etc.; producing statistics or other research results from business surveys at universities, research organizations, etc.; or using data produced from business surveys. The book also lays a foundation for new areas of research in business surveys. |
| electronic data capture training: Understanding Clinical Research Renato D. Lopes, Robert A. Harrington, 2013-05-22 A complete guide to understanding and applying clinical research results Ideal for both researchers and healthcare providers Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials--from study design and statistics to regulatory oversight--and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples--drawn from the authors' broad experience--that put chapter concepts into action and contribute to a working knowledge of integral research techniques. FEATURES: The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education Clear, comprehensive three-part organization: Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products, from initial human subject research to postapproval surveillance studies Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials |
| electronic data capture training: Clinical Research Informatics Rachel L. Richesson, James E. Andrews, Kate Fultz Hollis, 2023-06-14 This extensively revised new edition comprehensively reviews the rise of clinical research informatics (CRI). It enables the reader to develop a thorough understanding of how CRI has developed and the evolving challenges facing the biomedical informatics professional in the modern clinical research environment. Emphasis is placed on the changing role of the consumer and the need to merge clinical care delivery and research as part of a changing paradigm in global healthcare delivery. Clinical Research Informatics presents a detailed review of using informatics in the continually evolving clinical research environment. It represents a valuable textbook reference for all students and practising healthcare informatics professional looking to learn and expand their understanding of this fast-moving and increasingly important discipline. |
| electronic data capture training: Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations for 2002: Justification of the budget estimates, Department of State, Maritime Administration, the judiciary United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies, 2001 Test. |
Electronic Data Capture Systems and Data Management Best …
REDCap is a secure database used to record and maintain data and can be used as a CRF or a source document. Do I need hard copies of all of my source documents? No. However, there …
Medidata Rave Training - alznetproviders.org
Medidata Rave serves as the electronic data capture (EDC) for ALZ-NET. Each site staff member that will be entering in participant clinical data must have a Medidata Rave account to do so. Your …
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Detailed guidance on data collection, entry, navigation and general use of Medidata Rave is provided in the Medidata Rave Electronic Data Capture (EDC) Training Manual, which is posted …
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Oct 4, 2024 · Electronic data capture (EDC) has become a common and proven tool for data collection and management in clinical trials. Thus, understanding the principles and methods for …
Electronic Data Capture Updates
NACC is currently collaborating with the ADRCs to develop Electronic Data Capture (EDC) systems for UDSv4 that will effectively serve the needs of the ADRC program. Sign up to participate in the …
Electronic Data Capture Training (PDF) - archive.ncarb.org
Electronic Data Capture Training: Converting from Paper-based to Electronic Data Capture and Record Keeping in Clinical Trial Management Colton Castle,2016 Clinical research has lagged …
ELECTRONIC DATA CAPTURE: DEFINITION, ADVANTAGES …
EDC systems represent computerized systems that collect data in electronic format. They are used to gather sufficient patient data during the testing of new pharmaceuticals.
Auditing Electronic data capture in clinical trials (EDC
During CRO-Audits (e.g. in Clinical Pharmacology units) we see EDC-Systems, which support the study conduct and are used for documentation of data. During investigational site audits special …
Training on the Use of Technology - SPRIM
Regulatory agencies have consistently supported the use of electronic PRO (ePRO) data capture and recommended participant and site staff training on the correct use of electronic data capture …
Electronic Data Capture - octalsoft.com
Schedule a Demo with our Product Specialist today! We needed a centralized web-based database to manage the large amounts of healthcare data associated with the operation of global clinical …
FIVE QUESTIONS to Ask Before Choosing Your Electronic Data …
With the vast number of Electronic Data Capture (EDC) choices in the market today, how do you know which one is right for your organization?
Electronic Data Capture Training (Download Only)
electronic data capture and interactive response technologies Keeping the coverage practical the author focuses on the most critical information that impacts clinical trial conduct providing a full …
Electronic Data Capture Training (PDF)
Electronic Data Capture Training Society for the Advancement of Excellence in Education
Medidata Rave Training - alznetproviders.org
• Medidata Rave serves as the electronic data capture (EDC) for ALZ-NET. • Each site staff member that will be entering in participant clinical data must have a Medidata Rave account to do so.
Electronic Data Capture - MACRO - LeukemiaNet
Purpose of Electronic Data Capture •Obtain trial data in electronic form for subsequent analysis •Replace paper-based case report forms by electronic ones (e-CRFs) •Quality assurance: – …
Electronic Data Capture Training (PDF) - archive.ncarb.org
Mehto,Abhishek Jaiswal,2024-04-01 Open Electronic Data Capture Tools for Medical and Biomedical Research and Medical Allied Professionals explains the step by step of collecting and …
Data Management - HPTN
Detailed guidance on data collection, entry, navigation and general use of Medidata Rave is provided in the Medidata Rave Electronic Data Capture (EDC) Training Manual, which is posted …
Section 13. Data Management - HPTN
Signature” section of the Medidata Rave Electronic Data Capture (EDC) Training Manual and/or the Investigator e-Learning module for specific instructions. This step should only be done when …
Section 13. Data Management - HPTN
Detailed guidance on data collection, entry, navigation and general use of Medidata Rave is provided in the Medidata Rave Electronic Data Capture (EDC) Training Manual, which is posted
Electronic Data Capture Systems and Data Manag…
REDCap is a secure database used to record and maintain data and can be used as a CRF or a source document. …
Medidata Rave Training - alznetproviders.org
Medidata Rave serves as the electronic data capture (EDC) for ALZ-NET. Each site staff member that will be …
Section 13. Data Management - HPTN
Detailed guidance on data collection, entry, navigation and general use of Medidata Rave is provided in the …
Electronic Data Capture – Study Conduct, Maintenanc…
Oct 4, 2024 · Electronic data capture (EDC) has become a common and proven tool for data collection and …
Electronic Data Capture Updates
NACC is currently collaborating with the ADRCs to develop Electronic Data Capture (EDC) systems for UDSv4 …
