Practical Guide to Clinical Data Management

Susanne Prokscha

Detalles del libro
Editorial: CRC Press
ISBN: 1-57491-043-4
ISBN-13: 9781574910438
Materia: Libros de Farmacologia
Clinical data management (CDM) has changed from being an essentially clerical task in the late 1970s and early 1980s to a highly computerized, highly specialized field today. Clinical data managers have had to adapt their data management systems and processes accordingly. Practical Guide to Clinical Data Management steers readers through the role of data management in clinical trials and includes more advanced topics such as CDM systems, SOPs, and quality assurance. It helps readers establish GCP, manage laboratory data, ensure that DMB systems are in compliance with federal regulations, and deal with the kinds of clinical data that can cause difficulties in database applications.