Quick guide to good clinical practice : how to meet international quality standard in clinical research /
|Author / Creator:||Cingi, Cemal.|
|Imprint:||Cham, Switzerland : Springer, , ©2017.|
|Description:||1 online resource|
Total Quality Management -- standards.
HEALTH & FITNESS -- Holism.
HEALTH & FITNESS -- Reference.
MEDICAL -- Alternative Medicine.
MEDICAL -- Atlases.
MEDICAL -- Essays.
MEDICAL -- Family & General Practice.
MEDICAL -- Holistic Medicine.
MEDICAL -- Osteopathy.
|URL for this record:||http://pi.lib.uchicago.edu/1001/cat/bib/11268981|
|Summary:||<p>This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard - Good Clinical Practice - provided by the International Conference on Harmonization (ICH). </p> <p>The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC regulations, it includes step-by-step explanations of all the requirements that researchers should bear in mind when designing and performing new trials. Further topics covered include: ethics of clinical research; the drug development process and evolution of regulations; investigator and sponsor responsibilities; and clinical trial protocols.</p> Written by clinicians for clinicians, the book represents a valuable read also for researchers, pharmacists and all professionals involved in applications to the ethic committees, whose approval is required for new clinical studies.|
|Physical Description:||1 online resource|
|Bibliography:||Includes bibliographical references.|