Download or read book Clinical and Investigative Training written by National Cancer Institute (U.S.). Division of Cancer Treatment and published by . This book was released on 1980 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Principles and Practice of Clinical Research written by John I. Gallin and published by Elsevier. This book was released on 2011-04-28 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government
Download or read book Clinical Investigations at a Glance written by Jonathan Gleadle and published by John Wiley & Sons. This book was released on 2017-01-17 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Investigations at a Glance The market-leading at a Glance series is popular among healthcare students and newly qualified practitioners, for its concise and simple approach and excellent illustrations. Each bite-sized chapter is covered in a double-page spread with clear, easy-to-follow diagrams, supported by succinct explanatory text. Covering a wide range of topics, books in the at a Glance series are ideal as introductory texts for teaching, learning and revision, and are useful throughout university and beyond. Everything you need to know about Clinical Investigations... at a Glance! Clinical Investigations at a Glance provides an up-to-date, evidence-based overview of diagnostic investigations, looking at their choice, importance and interpretation for commonly presenting symptoms and conditions. Designed to help develop the evidence-based use of investigations and interpret results properly, the book provides a unique perspective on many critical issues in medical testing, with the aim of improving diagnostic accuracy and reducing unnecessary tests or harm. Clinical Investigations at a Glance is structured in three parts: an overview of tests; common presentations (such as chest pain, nausea and vomiting, weight loss and anaemia); and conditions organized by body system, such as cardiovascular disease, respiratory disease and nephrology. Key features include: How to interpret investigations, using high quality illustrations to compare ‘normal’ and ‘diseased’ results Evidence-based, including references How to select the most appropriate investigation, the accuracy of tests and how to manage incidental findings For more information on the complete range of Wiley medical student and junior doctor publishing, please visit: www.wileymedicaleducation.com To receive automatic updates on Wiley books and journals, join our email list. Sign up today at www.wiley.com/email All content reviewed by students for students Wiley Medical Education books are designed exactly for their intended audience. All of our books are developed in collaboration with students. This means that our books are always published with you, the student, in mind. If you would like to be one of our student reviewers, go to www.reviewmedicalbooks.com to find out more. This title is also available as an e-book. For more details, please see www.wiIey.com/buy/9781118759325
Download or read book Sponsor Clinical Investigator Training Drugs written by Kalman Dubov and published by Kalman Dubov. This book was released on 2022-01-07 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: These two modules present detailed training on conducting clinical investigations on drugs. The process to gain marketing approval from the US Food & Drug Administration requires extensive and detailed interaction with Agency officials, from inception through the different study trial phases. The requirements for the study sponsor and the principal investigator are different, but both must comply with the FDA's lengthy and detailed regulations and guidance documents. These modules are designed to assist the study sponsor and investigator to comply with the FDA, so that the study is conducted with minimal difficulty. The module begins with a discussion regarding the differences between medical care to that of a clinical investigation. The module continues with a regulatory definition of a drug, the general responsibilities of a clinical investigator, through study designs, to include documentation requirements for both the study sponsor and the investigator. Module B continues the training detailing how a protocol is submitted to the FDA, through the FDA audit process. These two modules will enable the study sponsor and clinical investigator to have detailed background knowledge of the nature of a drug's clinical investigation. As in all matters, knowledge of a subject is critical in understanding how the process works so that compliance is not a matter of guesswork.
Download or read book Sponsor Clinical Investigator Training Module A written by Kalman Dubov and published by Kalman Dubov. This book was released on 2022-01-07 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: These three modules are designed to assist both the sponsor and the clinical investigator in conducting professional investigational trials for biomedical devices. The US Food & Drug Administration has a specific Center for all bio-medical devices, with regulations and numerous guidance documents to assist the industry and investigators in the requirements for such trials. Bio-medical devices, their regulations, and requirements are perhaps the most complex and difficult to grasp for the new sponsor or clinical investigator. The regulatory nuances, frequently based on historic anomalies, drive the current regulatory process and those involved in such trials must be trained in these different requirements. While the detail is complex, following the different approval or clearance pathways correctly can result in receiving the Agency's marketing approval or clearance in a ready-made format. These three modules provide the basics of such understanding and compliance. The first module begins with the difference between regular physician-based care for a patient to the clinical investigator who follows the restrictions of the protocol and the consequent consent form. Similarly, off-label use of a device in a physician's office differs from an off-label trial, with the latter requiring submissions to the FDA before beginning the clinical trial. A unique subset of biomedical devices is that the device may be a combination device (device-drug or device-biologic) requiring careful scrutiny as to which regulatory framework controls. This Module also includes sponsor responsibilities, to the FDA, the principal investigator, and the reviewing IRB. Module B continues the overview, with the responsibilities of the principal investigator, followed by the protocol-driven Investigational Device protocol to the FDA. I also include studies with apps, a timely matter considering the wide use of apps on today's smartphones. Module C reviews the consent form for study subjects, followed by a review of FDA's three 510(k) processes, followed by the FDA audit. The audit can be a scary proposition, especially for the site that has not prepared for it. I offer recommendations for such preparation. These three modules, though comprehensive, can be mastered to the great benefit of the investigational community, and more so, for the patient who will receive an approved or cleared device that has been tested with proven efficacy.
Download or read book Ethical and Regulatory Aspects of Clinical Research written by Ezekiel J. Emanuel and published by . This book was released on 2003 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt: Professionals in need of such training and bioethicists will be interested.
Download or read book Sponsor Clinical Investigator Training Module B Biologics written by Kalman Dubov and published by Kalman Dubov. This book was released on with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical investigations with biologics are commonly complex, requiring detailed knowledge of the regulatory frameworks for both drugs and biologics since the Food & Drug Administration applies the regulations for drugs as well as for biologics for such clinical investigations. The complexity is furthered if the article is a combination biologic-drug or biologic-device. These three modules are designed to assist the sponsor and clinical investigator in conducting professional investigational trials for biologics. The FDA has a specific Center for biologics, with regulations and many guidance documents to assist the industry and investigators in the requirements for such trials. These two modules provide the basics of understanding the regulatory framework and complying with the Agency's requirements. Module A focuses on the Principal Investigator and the responsibilities necessary to comply with FDA requirements during the course of the clinical trial. The module begins with the definition of a biologic, followed by a review of clinical trials, gene transfer studies, the clinical investigator's responsibilities during the trial with regard to documentation, risks, how to respond to the study sponsor, the Data Safety Monitoring Board (DSMB), and the FDA. The module concludes with details regarding the consent form and process, detailing what is necessary to consent a subject into the study. Module B focuses on the study sponsor and the submissions to the FDA for permission to begin the study. The module begins with a review of the protocol sections, together with the electronic Common Technical Document (eCTD), the phases of the clinical investigation, a review of combination products, dual-use technologies, concluding with the FDA audit. These two modules, though comprehensive, can be mastered to the great benefit of the investigational community, and more so, for the patient who will receive an approved biologic that has proven efficacy.
Download or read book Sponsor Clinical Investigator Training biomedical Devices Module B written by Kalman Dubov and published by Kalman Dubov. This book was released on 2022-01-07 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: These three modules are designed to assist both the sponsor and the clinical investigator in conducting professional investigational trials for biomedical devices. The US Food & Drug Administration has a specific Center for all bio-medical devices, with regulations and numerous guidance documents to assist the industry and investigators in the requirements for such trials. Bio-medical devices, their regulations, and requirements are perhaps the most complex and difficult to grasp for the new sponsor or clinical investigator. The regulatory nuances, frequently based on historic anomalies, drive the current regulatory process and those involved in such trials must be trained in these different requirements. While the detail is complex, following the different approval or clearance pathways correctly can result in receiving the Agency's marketing approval or clearance in a ready-made format. These three modules provide the basics of such understanding and compliance. The first module begins with the difference between regular physician-based care for a patient to the clinical investigator who follows the restrictions of the protocol and the consequent consent form. Similarly, off-label use of a device in a physician's office differs from an off-label trial, with the latter requiring submissions to the FDA before beginning the clinical trial. A unique subset of biomedical devices is that the device may be a combination device (device-drug or device-biologic) requiring careful scrutiny as to which regulatory framework controls. This Module also includes sponsor responsibilities, to the FDA, the principal investigator, and the reviewing IRB. Module B continues the overview, with the responsibilities of the principal investigator, followed by the protocol-driven Investigational Device protocol to the FDA. I also include studies with apps, a timely matter considering the wide use of apps on today's smartphones. Module C reviews the consent form for study subjects, followed by a review of FDA's three 510(k) processes, followed by the FDA audit. The audit can be a scary proposition, especially for the site that has not prepared for it. I offer recommendations for such preparation. These three modules, though comprehensive, can be mastered to the great benefit of the investigational community, and more so, for the patient who will receive an approved or cleared device that has been tested with proven efficacy.
Download or read book Medicolegal Death Investigation System written by Institute of Medicine and published by National Academies Press. This book was released on 2003-08-22 with total page 85 pages. Available in PDF, EPUB and Kindle. Book excerpt: The US Department of Justice's National Institute of Justice (NIJ) asked the Institute of Medicine (IOM) of The National Academies to conduct a workshop that would examine the interface of the medicolegal death investigation system and the criminal justice system. NIJ was particularly interested in a workshop in which speakers would highlight not only the status and needs of the medicolegal death investigation system as currently administered by medical examiners and coroners but also its potential to meet emerging issues facing contemporary society in America. Additionally, the workshop was to highlight priority areas for a potential IOM study on this topic. To achieve those goals, IOM constituted the Committee for the Workshop on the Medicolegal Death Investigation System, which developed a workshop that focused on the role of the medical examiner and coroner death investigation system and its promise for improving both the criminal justice system and the public health and health care systems, and their ability to respond to terrorist threats and events. Six panels were formed to highlight different aspects of the medicolegal death investigation system, including ways to improve it and expand it beyond its traditional response and meet growing demands and challenges. This report summarizes the Workshop presentations and discussions that followed them.
Download or read book Unexplained Pediatric Deaths written by Elizabeth Bundock and published by . This book was released on 2019-11-08 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication reviews medicolegal investigation of sudden, unexpected pediatric deaths, focusing on systems and procedures in the United States and those deaths which remain incompletely understood or entirely unexplained. It discusses the evolution of our understanding and practice in the area of sudden, unexpected pediatric death investigation, covering the changing philosophies and medical theories as to causation and changing investigative and certification strategies. Procedural guidance for investigation, autopsy and ancillary testing, certification and reporting, and key considerations for prevention, research and working with family members and other professional team members are provided.The path to production of this publication began in 2016 when the National Association of Medical Examiners received a scientific grant from the SUDC Foundation called "Sudden Death in Pediatrics: Consensus for Investigation, Certification, Research Direction and Family Needs" to convene, in collaboration with the American Academy of Pediatrics, an expert panel to identify and discuss the diverse issues and limitations surrounding these deaths and build a foundation for national consensus. The combined effort of a panel of medical examiners, pediatricians, and federal agency representatives, representing the diverse interests of death investigation, autopsy performance, certification, clinical subspecialties (pediatrics, neurology, cardiology, child abuse, injury prevention, infectious diseases, genetics, and metabolic diseases), family needs, prevention, and epidemiology, culminated in this publication.
Download or read book Oxford Handbook of Clinical and Laboratory Investigation written by Drew Provan and published by OUP Oxford. This book was released on 2010-07-15 with total page 829 pages. Available in PDF, EPUB and Kindle. Book excerpt: Modern medicine is highly complex and investigations are a key part of the diagnostic process. With major advances in technology there are thousands of clinical and laboratory tests available. This book provides a patient-oriented approach to investigation. The first chapter describes key symptoms and signs along with tests that may be of value in reaching a diagnosis. The remainder of the book is specialty-centred and provides a comprehensive review of all available tests within a given subject. The aim is of the book is to provide a more rational method of investigation and prevent over-investigation which is expensive for the hospital and unpleasant for the patient. It emphasises which tests are of value, when tests are not likely to be helpful, along with pitfalls in the interpretation of results. This new edition has been updated throughout to incorporate current investigations and management of disease. Chapters on rheumatology, radiology, and renal medicine have been extensively revised. With contributions from active clinicians who are engaged in medical practice, the book will be of value to senior medical students facing finals examinations, and junior doctors who are responsible for ordering tests on their patients.
Download or read book Sponsor Clinical Investigator Training Biomedical Devices Module C written by Kalman Dubov and published by Kalman Dubov. This book was released on 2022-01-07 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: These three modules are designed to assist both the sponsor and the clinical investigator in conducting professional investigational trials for biomedical devices. The US Food & Drug Administration has a specific Center for all bio-medical devices, with regulations and numerous guidance documents to assist the industry and investigators in the requirements for such trials. Bio-medical devices, their regulations, and requirements are perhaps the most complex and difficult to grasp for the new sponsor or clinical investigator. The regulatory nuances, frequently based on historic anomalies, drive the current regulatory process and those involved in such trials must be trained in these different requirements. While the detail is complex, following the different approval or clearance pathways correctly can result in receiving the Agency's marketing approval or clearance in a ready-made format. These three modules provide the basics of such understanding and compliance. The first module begins with the difference between regular physician-based care for a patient to the clinical investigator who follows the restrictions of the protocol and the consequent consent form. Similarly, off-label use of a device in a physician's office differs from an off-label trial, with the latter requiring submissions to the FDA before beginning the clinical trial. A unique subset of biomedical devices is that the device may be a combination device (device-drug or device-biologic) requiring careful scrutiny as to which regulatory framework controls. This Module also includes sponsor responsibilities, to the FDA, the principal investigator, and the reviewing IRB. Module B continues the overview, with the responsibilities of the principal investigator, followed by the protocol-driven Investigational Device protocol to the FDA. I also include studies with apps, a timely matter considering the wide use of apps on today's smartphones. Module C reviews the consent form for study subjects, followed by a review of FDA's three 510(k) processes, followed by the FDA audit. The audit can be a scary proposition, especially for the site that has not prepared for it. I offer recommendations for such preparation. These three modules, though comprehensive, can be mastered to the great benefit of the investigational community, and more so, for the patient who will receive an approved or cleared device that has been tested with proven efficacy.
Download or read book The Evidence Base of Clinical Diagnosis written by J. Andre Knottnerus and published by BMJ Books. This book was released on 2009-01-26 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: This unique book presents a framework for the strategy and methodology of diagnostic research, in relation to its relevance for practice. Now in its second edition The Evidence Base of Clinical Diagnosis has been fully revised and extended with new chapters covering the STARD guidelines (STAndards for the Reporting of Diagnostic accuracy studies) and the multivariable analysis of diagnostic data. With contributions from leading international experts in evidence-based medicine, this book is an indispensable guide on how to conduct and interpret studies in clinical diagnosis. It will serve as a valuable resource for all investigators who want to embark on diagnostic research and for clinicians, practitioners and students who want to learn more about its principles and the relevant methodological options available.
Download or read book Investigative and Forensic Interviewing written by Craig N. Ackley and published by CRC Press. This book was released on 2010-12-02 with total page 198 pages. Available in PDF, EPUB and Kindle. Book excerpt: Investigative and Forensic Interviewing: A Personality-Focused Approach looks at the personality styles most commonly encountered in the criminal justice system and demonstrates how to use this insight to plan and conduct a productive interview. The book includes chapters on narcissistic, antisocial, psychopathic, borderline, inadequate/immature, p
Download or read book Responsible Conduct of Research written by Adil E. Shamoo and published by Oxford University Press. This book was released on 2009-02-12 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent scandals and controversies, such as data fabrication in federally funded science, data manipulation and distortion in private industry, and human embryonic stem cell research, illustrate the importance of ethics in science. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today.
Download or read book A Practical Guide to Managing Clinical Trials written by JoAnn Pfeiffer and published by CRC Press. This book was released on 2017-05-18 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
