Practical Guide to Clinical Data Management, Third Edition

ABOUT THE BOOK

Practical Guide to Clinical Data Management, Third Edition by Susanne Prokscha is a comprehensive, practical resource for understanding the processes and systems involved in managing data throughout clinical trials. It explains how clinical data is collected, reviewed, processed, validated, and prepared for analysis and regulatory submission, with particular emphasis on the growing use of electronic data capture (EDC) systems in clinical research.

The book follows the clinical data management lifecycle through three major phases: study startup, study conduct, and study closeout. It covers essential activities such as developing a data management plan, designing case report forms (CRFs) and databases, establishing edit checks, preparing for data collection, monitoring incoming data, resolving discrepancies, and maintaining accurate clinical trial records. It also addresses laboratory data, non-CRF data, adverse event reporting, data transfers, quality control, and database locking.

Beyond day-to-day procedures, the book explores the infrastructure required for effective clinical data management. Topics include standard operating procedures (SOPs), staff training, access control, data security, collaboration with contract research organizations (CROs), and the selection, implementation, validation, and maintenance of clinical data management systems. Additional coverage of coding dictionaries, system testing, change control, data migration, and archiving provides a broader understanding of the technical and operational responsibilities involved.

Designed for clinical data managers, clinical research professionals, pharmaceutical and biotechnology teams, CRO personnel, and students entering the field, this edition offers practical guidance for managing clinical trial information efficiently and consistently. Its structured approach makes it a useful reference for understanding the complete data management process and supporting reliable, high-quality clinical research.

ABOUT THE AUTHOR

Susanne Prokscha is an experienced clinical data management professional and independent consultant with expertise in clinical data management (CDM) processes, technologies, and systems. She has been involved in the field since the mid-1980s, working both as a consultant and directly with organizations of different sizes. Through this experience, she has developed broad knowledge of clinical studies and the data management systems used throughout clinical research.

Since 2007, Prokscha has focused particularly on developing standard operating procedures (SOPs), managing documentation, and creating training plans for clinical data management and other clinical research and development functions. Her practical industry experience and commitment to improving clinical data management practices inform her approach to explaining the processes, systems, and responsibilities involved in managing clinical trial data.