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.