"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.

Up to date and easy to navigate, Fischbach’s A Manual of Laboratory and Diagnostic Tests, 11th Edition, details an extensive array of laboratory and diagnostic tests to prepare nurses and health professionals to deliver safe, effective, informed patient care. This proven manual is organized the way nurses think — by specimen, function, and test type— and provides current, comprehensive, step-by-step guidance on correct procedures, tips for accurate interpretation, and expert information on patient preparation and aftercare.

Laboratory animal research remains a very important part of basic research and drug development. This book rectifies the problem by providing animal researchers and technicians with the essentials for conducting their work in the laboratory, offering detailed protocols and information that can be referred to on a daily basis.

Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".

Nursing-focused and easy-to-read, this manual delivers all of the information you need to understand how tests work, interpret their results, and provide quality patient care—pre-test, intra-test, and post-test. Tests and procedures are listed in alphabetical order by their complete names for quick reference. The integrated index allows fast searches by abbreviation, synonym, disease/disorder, specimen type, or test classification. Plus, a Body Systems Appendix includes a list of common laboratory and diagnostic tests for each body system as well as nutrition-related lab tests.

This is the 1st edition of the book Manual of Medical Laboratory Techniques. The text is comprehensive, updated and fully revised as per the present day requirements in the subject of medical laboratory technique. In this book principles, methodologies, results norms, interpretations diseases concerned and bibliography are included for each test. The book has 5 chapters. The first chapter deals with biochemical tests. Chapter two provides a comprehensive description of tests done for genetic analysis. A sound foundation of understanding of test in hematology, microbiology and serology is provided in next 2 chapters. Chapter 5th, deals with ophthalmic histopathology. A comprehensive index is given at last.