Practical guide human research (29 Ergebnisse)
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Sprache: Englisch
Verlag: Cambridge University Press, 2017
Serie: Buch 38 von 52 - Cambridge Studies in Biological and Evolutionary Anthropology
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Verlag: PharmaMed Press/BSP Books, 2024
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Soft cover. Zustand: New. Contents: 1. Clinical Research A Clinical Investigator's Perspective 2. Medical Device Development, Process and Regulation 3. Preclinical Drug Development 4. Phases of Clinical Trials 5. Phase 0 Micro dosing Studies 6. Clinical Research Planning 7. Clinical Research Design 8. Clinical Research Protocol…9. Designing Case Report Forms 10. Process of Randomization in Clinical Trials 11. Investigational Medicinal Products 12. Multi center Clinical Trials 13. Good Clinical Research Practice 14. Role and Responsibilities of Sponsor 15. Role and Responsibilities of Principal Investigator 16. Ethical Consideration in Clinical Research Special Reference to Developing Countries 17. Informed Consent in Clinical Research 18. Monitoring in Clinical Trials 19. Quality Assurance in Clinical Research 20. Pharmacovigilance and Drug Safety 21. Data and Safety Monitoring Board and Monitoring Plan 22. Standard Operating Procedures 23. Archiving Clinical Research Documents 24. Evidence Based Medicine 25. Clinical Research Data Management 26. Clinical Biostatistics, (a) Biostatistics for clinical Researcher, (b) Terminology used in Biostatistics In "A Practical Guide to Human Research and Clinical Trials," delve into the intricate world of clinical research as health professionals navigate the complexities of conducting trials and recruiting subjects. This comprehensive textbook offers a detailed exploration of the scientific, administrative, and regulatory aspects crucial to the successful execution of clinical trials. Designed as a valuable resource for both seasoned professionals and aspiring students, this book illuminates key concepts with insightful diagrams and practical checklists, making it an essential teaching aid and a go-to reference guide. From the design and implementation to the analysis of clinical trials, this book equips readers with the knowledge and tools necessary to navigate every phase of the research process. "A Practical Guide to Human Research and Clinical Trials" is a must-read for those seeking to excel in the field of health and research, offering a wealth of knowledge to empower and inspire.
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Taschenbuch. Zustand: Neu. Druck auf Anfrage Neuware - Printed after ordering - This Briefintroduces engineers to the main principles in ethics, research design, statistics, and publishing ofhuman subject research. In recent years, engineering has become strongly connected to disciplines such as biology, medicine, and psychology…. Often, engineers (and engineering students) are expected to perform human subject research. Typical human subject research topics conducted by engineers include human-computer interaction (e.g., evaluating the usability of software), exoskeletons, virtual reality, teleoperation, modelling of human behaviour and decision making (often within the framework of 'big data' research), product evaluation, biometrics, behavioural tracking (e.g., of work and travel patterns, or mobile phone use), transport and planning (e.g., an analysis of flows or safety issues), etc. Thus, it can be said that knowledge on how to do human subject research is indispensable for a substantial portion of engineers. Engineers are generally well trainedin calculus and mechanics, but may lack the appropriate knowledge on how to do research with human participants. In order to do high-quality human subject research in an ethical manner, several guidelines have to be followed and pitfalls have to be avoided. This book discusses these guidelines and pitfalls. The aim is to prepare engineers and engineering students to carry out independent research in a responsible manner.
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Taschenbuch. Zustand: Neu. Neuware - Media headlines about research misconduct in American Universities have focused public attention on the dramatic ethical problems that can arise during the conductof research. In the current atmosphere of accountability, scientific research on humans is now under increased scrutiny by the med…ia, Congress and the public. Ethics of the Use of Human Subjects in Research fills the need for learning materials and strategies providing support for training programs related to the ethics of the use of human subjects in research. It presents a practical introduction to the ethical issues at stake in the conduct of research with human subjects. Beginning with a chapter on research ethics, a total of 10 chapters range in scope from the deveolopment of a protocol for ethical decision making to how to obtain IRB approval, with an emphasis on ethical factors underpinning the IRB process.
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Taschenbuch. Zustand: Neu. Druck auf Anfrage Neuware - Printed after ordering - Regulations on human subjects research have evolved over a 20-year period and now provide a formal set of requirements for the conduct of federally sponsored studies. Over time, government regulations, like taboos in primitive societies, develop a li…fe of their own, seemingly dissociated from their origins and justifica tions. When the investigator suffers the burdens of trying to comply with com plex rules, it is easy for him or her to lapse into a frustration that can be eased by being informed or reminded of why the rules were created in the first place and what they were designed to accomplish. Dennis Maloney's work provides a handy historical record of the processes by which the regulations were created and modified. He also recounts his own experience with research at Boys Town and provides instructions on how to cope with the system. It is difficult to find in one place the current status and appropriate citations for regulations as well as the contacts and know-how to obtain more information on the subject. In this respect, by providing a history and guide to interpretation and compliance, 'Protection of Human Subjects' is a reference of importance and utility to the investigator entering into or working in the field of biomedical or behavioral research involving human subjects.
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Zustand: New. Naidu, M. U. R. Rani, P. UshaMUR Naidu, Professor and Head, P Usha Rani Additional Professor, Departrnent of Clinical Pharrnacology and Therapeutics, Nizarn s Institute of Medical Sciences, Panjagutta, Hyderabad.Regulatory bodies such as the Eu.
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Buch. Zustand: Neu. Neuware - Regulatory bodies such as the European Medicine Agency have done tremendous work in collaboration with experts from the field to develop Good Clinical Practices that apply not only in Europe but also in emerging countries. Designed to be a teaching aid and reference guide, A Practical Guide to Human… Research and Clinical focuses on ethics, regulations, and guidelines.Conducting a successful clinical trial requires not only a strong basic knowledge, but also hands-on practical training. The book explains the intricate details of the subject to readers by citing concrete cases, exercises, and templates along with the theoretical aspects. Prof. M.U.R Naidu and his co-authors address all aspects of clinical trials from clinical research, drug development, and quality to methodology, biostatistics, and pharmacovigilance.
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Zustand: New. Provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a range of topics, such as consent, confidentiality, subject recruitment and selection, and Institutional Review Board, this book offers useful strategies for achieving regulatory complianc…e while reducing liability. Num Pages: 656 pages, charts. BIC Classification: MBGR; MBQ. Category: (P) Professional & Vocational. Dimension: 260 x 184 x 37. Weight in Grams: 1306. . 2003. 1st Edition. Hardcover. . . . . Books ship from the US and Ireland.
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Buch. Zustand: Neu. A Practical Guide to Human Research and Clinical Trials | M. U. R. Naidu (u. a.) | Buch | Einband - fest (Hardcover) | Englisch | 2013 | Taylor & Francis Inc | EAN 9781466591172 | Verantwortliche Person für die EU: Libri GmbH, Europaallee 1, 36244 Bad Hersfeld, gpsr[at]libri[dot]de | Anbieter: preigu.
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Buch. Zustand: Neu. Neuware - This easy-to-read reference book provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a broad range of topics, such as consent, confidentiality, subject recruitment and selection, the role of the investigator and Institutional… Review Board, it offers timely and useful strategies for achieving regulatory compliance while reducing liability. In addition, insurance, quality management, accreditation, and risk management are topics examined in the book. The practical insights found in this volume are not found in other books on the subject. Clinical Trials and Human Research is a practical tool to help anyone involved in clinical research.
Verlag: PharmaMed Press, 2011
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In den WarenkorbContents 1 Clinical Research A Clinical Investigators Perspective 2 Drug and Device Development Process 3 Preclinical Drug Development 4 Phases of Clinical Trials 5 Phase 0 - Microdosing Stdies 6 Clinical Research Planning 7 Clinical Research Design 8 Clinical Research Protocol 9 Designing Case Report Forms 10 Process of Randomi…zation in Clinical Trials 11 Investigational Medicinal Products 12 Multicenter Clinical Trials 13 Good Clinical Research Practice 14 Role and Responsibilities of Sponsor 15 Role and Responsibilities of Principal Investigator 16 Ethical Consideration in Clinical Research Special Reference to Developing Countries 17 Informed Consent in Clinical Research 18 Monitoring in Clinical Trials 19 Quality Assurance in Clinical Research 20 Pharmacovigilance and Drug Safety 21 Data and Safety Monitoring Board and Monitoring Plan 22 Standard Operating Procedures 23 Archiving Clinical Research Documents 24 Evidence Based Medicine 25 Clinical Research Data Management 26 Clinical BiostatisticsAbout the Book Many health professionals are expected to conduct their own trial or to participate in trials by recruiting subjects Everyone who is conducting clinical research should have a sufficient understanding of the scientific and administrative aspect including an awareness of the regulation and guidelines associated with clinical trials This textbook addresses many issues of human clinical research and clinical trials and provides comprehensive overview of the design conduct and analysis of all the phases of clinical trials It is aimed at health and other research professionals and students Salient Features Book can be used as teaching aid and as a reference guide Important concepts are presented throughout the chapters with diagrams and check lists.
