Clinical research coordinator handbook /

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Hlavní autor:	Norris, Deborrah
Médium:	Kniha
Jazyk:	English
Vydáno:	Medford, NJ : Plexus Pub., c2009.
Vydání:	4th ed.
Témata:	Clinical trials > United States > Handbooks, manuals, etc. Clinical Trials as Topic > standards > United States > Handbooks. Clinical Trials as Topic > methods > United States > Handbooks. Records as Topic > standards > United States > Handbooks. Research Design > standards > United States > Handbooks.
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Obsah:

Federal regulations governing the obligations of clinical investigators of regulated articles
The clinical research organization
Investigator responsibilities
Duties of the clinical research coordinator
The creation of study source documents
Obtaining informed consent and assent approval
Pertinent forms and study records
The prestudy site visit
Recruiting and enrolling subjects
Conducting the study and keeping records
Preparing for an FDA audit
Clinical research : potential liability
Writing the study sumary
Achieving credibility and recognition as a Clinical Research Coordinator
Electronic data capture and clinical trials.

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