prokscha

The management of clinical data, from its collection during a trial to its extraction for analysis, has become critical in preparing a regulatory submission and obtaining approval to market a treatment. Groundbreaking on its initial publication nearly 14 years ago, and evolving with the field in each iteration since then, this latest volume includes revisions to all chapters to reflect the recent updates to ICH E6, good clinical practices, electronic data capture, and interactive response technologies. Keeping the coverage practical, the author focuses on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview for clinical data managers.

Features:

• Provides an introduction and background information for the spectrum of clinical data management tasks.
• Outstanding text in the industry and has been used by the Society for Clinical Data Management in creating its certification exam.
• Explains the high-level flow of a clinical trial from creation of the protocol through study lock.
• Reflects electronic data capture and interactive response technologies.
• Discusses using the concept of three phases in the clinical data management of a study: study startup, study conduct, and study closeout, to write procedures and train staff.

Susanne Prokscha - previously Director, R&D Process and Training, Jazz Pharmaceuticals. She has been involved in Clinical Data Management (CDM) process and technologies since the mid-1980’s. She has worked both as a consultant and directly for companies large and small, gaining experience with a wide range of studies and a variety of clinical data management systems. Since 2007, Susanne has been focusing on SOP development, document management, and training plans for CDM and recently for all Clinical Research and Development.