Bøger af Susanne Prokscha

This book discusses managing SOPs for GCP from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user's point of view to keep topics focused on the practical aspects of SOPs and SOP management.

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 fourteen 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.

This book discusses managing SOPs for GCP from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user¿s point of view to keep topics focused on the practical aspects of SOPs and SOP management.