EAN: 9783319546926

DEVELOPING A SUCCESSFUL CLINICAL RESEARCH PROGR...

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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