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Developing a Successful Clinical Research Program (Paperback, 1st ed. 2018)
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Developing a Successful Clinical Research Program (Paperback, 1st ed. 2018)
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This unique book is designed to help a medical team become a
clinical research team. It includes practical information and tips
for the initial stages of clinical research: building a team,
negotiating a contract, developing a budget, and writing and
improving a patient consent. Chapters describing the nuts and bolts
of how to actually perform the study follow, including patient
recruiting and retention, screening, follow-ups and handling
monitor visits. Finally, there is discussion of the yearly reviews
and disclosures and not just surviving, but acing, the
all-important Food and Drug Administration audit. Clinical research
moves medicine forward and is a necessary part of bringing any new
therapy, device, or procedure into routine medical care. However,
it can be costly and convoluted, and the methodologies of clinical
research are not widely standardized. Decreasing some of the chaos
present in American clinical research is the primary goal of this
book. The second goal is to improve the understanding and education
of those who enter clinical research, whether in the frontline work
of the clinical research site, in the middleman companies who have
a high turnover rate, at a research hospital or institution, or at
medical corporations that depend on good clinical research to bring
their products to market. The third reason is to standardize
American clinical research and to remove some of the vagaries and
inconsistencies in the field. Practical and user-friendly,
Developing a Successful Clinical Research Program fills a need for
a clear guide to developing and improving a first-class research
program in any clinical setting.
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