A thorough introduction of the main ideas and procedures of clinical research is given in The Fundamentals of Clinical Research 1st Edition PDF: A Universal Guide for Implementing Good Clinical Practice, 1st Edition. Anybody interested in clinical research, including clinicians, researchers, sponsors, and regulatory agencies, can use the book as a general reference.
Features of The Fundamentals of Clinical Research 1st Edition PDF
- Prepared by P. Michael Dubinsky, an Instructor in the areas of clinical trial compliance, regulatory audits, and quality at the University of California Berkeley Extension Programs, and Karen A. Henry, a clinical research professional.
- From the fundamental ideas of study design and protocol development to the ethical and legal concerns involved in running clinical trials, the book covers all the significant facets of clinical research. It offers a step-by-step explanation of how to carry out a clinical trial, from the preliminary planning stage to the final analysis and outcome reporting.
- Six sections that each cover a different area of clinical research make up the book’s structure. The first section gives a general review of the fundamental ideas in clinical research, outlining the many clinical trial types, the value of randomization and blinding, and the various stages of clinical development.
- The establishment of study objectives, the choice of study populations, and the choice of study endpoints are all covered in the second section, which also focuses on study design and protocol development. The section also discusses the crucial factors to take into account while creating a protocol, such as the adoption of established procedures and the significance of getting input from all pertinent parties.
- The final part of the book discusses the moral and legal issues that come up when doing clinical research. This includes a description of the moral precepts that guide clinical research as well as a summary of the international legal system that oversees clinical trials.
- The fourth chapter of the book deals with the practical components of running a clinical trial, such as finding research participants, gathering and managing data, and keeping track of the experiment’s progress and adverse occurrences.
- The analysis and reporting of clinical trial outcomes, including the use of statistical techniques to data analysis and the creation of clinical research reports, are covered in the fifth section of the book.
- The sixth portion of the book concludes the book by summarizing the important ideas and principles presented in the earlier sections and by talking about the opportunities and challenges that clinical research will face in the future.
Contents of The Fundamentals of Clinical Research 1st Edition
- Good clinical practice history
- Drug development in the regulatory environment
- Good clinical practice
- Individual clinical trial
- Quality in clinical practice
- Index
We show some opinions of the book readers
Wilson W. said it is recognized as a valuable tool for anyone working in clinical research. Readers laud the book’s step-by-step instructions and detailed discussion of the fundamental ideas and methods of clinical research. Clinicians, researchers, sponsors, and regulatory agencies have all found the book’s practical advice and insights to be beneficial. The book has received praise for its lucid writing, which makes difficult subjects simple to comprehend, and for its well-organized layout, which facilitates reading.
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