Clinical Research Coordinator Handbook - 9780937548707

In this handbook, Norris, a former clinical research coordinator herself, outlines the various functions required of the clinical research coordinator (CRC), research nurse, research assistant, data coordinator, or medical assistant involved in conducting a clinical study on behalf of a pharmaceutical company or device manufacturer and a contract research or site management organization. The handbook describes the duties of CRCs, reviews the national and international regulatory requirements that must be followed for a clinical study, and describes required documentation. Also covered are site visits, recordkeeping, the FDA audit, and writing the study summary. Appendices offer contacts for clinical research resources, FDA web sites for institutional review boards and clinical investigators, and about 30 pages of sample forms, letters, and checklists used during the course of a clinical study. This fourth edition contains a new chapter on EDC, and an expanded glossary. Norris is a veteran of the pharmaceutical industry. Annotation ©2010 Book News, Inc., Portland, OR (booknews.com)