Clinical research coordinator handbook
By: Deborrah Norris.
Edition: 4th ed.
Publisher: Plexus Pub.
Published: 2009
Place of publication: Medford, NJ
Language: eng
ISBN-13: 9780937548707
Subjects: 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
Genres: Handbooks, manuals, etc; Handbooks
Notes: Includes bibliographical references.
Table of contents: title: Federal regulations governing the obligations of clinical investigators of regulated articles; title: The clinical research organization; title: Investigator responsibilities; title: Duties of the clinical research coordinator; title: The creation of study source documents; title: Obtaining informed consent and assent approval; title: Pertinent forms and study records; title: The prestudy site visit; title: Recruiting and enrolling subjects; title: Conducting the study and keeping records; title: Preparing for an FDA audit; title: Clinical research : potential liability; title: Electronic data capture (EDC) and clinical trials.