Norris, Deborrah.

Clinical research coordinator handbook / Deborrah Norris. - 4th ed. - Medford, NJ : Plexus Pub., c2009. - x, 157 p. ill. ; 28 cm.

SEN.: 272/47 No.:01 FY: 2072/73

Includes bibliographical references.

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.

9780937548707

2009030187


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.

R853.C55 / N67 2009

610.72

QV 39 / N854c 2009