The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then, the third edition of Practical Guide to Clinical Data Management includes important updates to all chapters to reflect the current industry approach to using electronic data capture (EDC) for most studies.
See what's new in the Third Edition: A chapter on the clinical trial process that explains the high level flow of a clinical trial from creation of the protocol through the study lock and provides the context for the clinical data management activities that follow Reorganized content reflects an industry trend that divides training and standard operating procedures for clinical data management into the categories of study startup, study conduct, and study closeout Coverage of current industry and Food and Drug Administration (FDA) approaches and concerns The book provides a comprehensive overview of the tasks involved in clinical data management and the computer systems used to perform those tasks. It also details the context of regulations that guide how those systems are used and how those regulations are applied to their installation and maintenance. Keeping the coverage practical rather than academic, the author hones in on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview or introduction for clinical data managers.
STUDY STARTUP The Data Management Plan CRF Design Considerations Database Design Considerations Defining Edit Checks Preparing to Receive Data STUDY CONDUCT Receiving Data on Paper Overseeing Data Collection Cleaning Data Lab Data and Non-CRF Data Collecting AE Data Creating Reports and Transferring Data STUDY CLOSEOUT Preparing to Lock Quality Control Locking and Unlocking Studies NECESSARY INFRASTRUCTURE Standard Operating Procedures Training Controlling Access and Security Working with CROs and Service Providers CDM SYSTEMS CDM Systems Choosing Vendor Products Implementing New Systems System Validation Test Procedures Change Control Coding Dictionaries