Research Catalog

Title

Practical guide to clinical data management / Susanne Prokscha.

Author

Prokscha, Susanne.

Publication

Boca Raton, FL : CRC/Taylor & Francis, [2007], ©2007.

Supplementary Content

Publisher description

Items in the Library & Off-site

Holdings

Details

Description

xiv, 238 pages; 25 cm

Alternative Title

Clinical data management

Subjects

• Clinical trials > Data processing
• Drugs > Testing > Data processing
• Clinical Trials as Topic
• Database Management Systems > organization & administration
• Database management
• Information Management > organization & administration
• Data Collection > methods

Note

• Includes index.

Bibliography (note)

• Includes bibliographical references and index.

Contents

Ch. 1. The data management plan -- Ch. 2. CRF design considerations -- Ch. 3. Database design considerations -- Ch. 4. Study setup -- Ch. 5. Entering data -- Ch. 6. Tracking CRF pages and corrections -- Ch. 7. Cleaning data -- Ch. 8. Managing laboratory data -- Ch. 9. Collecting adverse event data -- Ch. 10. Creating reports and transferring data -- Ch. 11. Locking studies -- Ch. 12. Standard operating procedures and guidelines -- Ch. 13. Training -- Ch. 14. Controlling access and security -- Ch. 15. Working with CROs -- Ch. 16. Clinical data management systems -- Ch. 17. Electronic data capture systems -- Ch. 18. Choosing vendor products -- Ch. 19. Implementing new systems -- Ch. 20. System validation -- Ch. 21. Test procedures -- Ch. 22. Change control -- Ch. 23. Coding dictionaries -- Ch. 24. Migrating and archiving data -- App. A. Data management plan outline -- App. B. Typical data management standard operating procedures -- App. C. CRO-sponsor responsibility matrix -- App. D. Implementation plan outline -- App. E. Validation plan outline -- App. F. CDISC and HIPAA.

ISBN

• 0849376157 (Hardcover : alk. paper)
• 9780849376153 (Hardcover : alk. paper)

LCCN

2006043887

OCLC

• ocm65360967
• 65360967
• SCSB-5327592

Owning Institutions

Columbia University Libraries