Boca Raton: Taylor & Francis. - 2007. - 239 p. Practical Guide to Clinical Data Management, Second Edition provides a solid introduction to the key process elements of clinical data management. Offering specific references to regulations and other FDA documents, it gives guidance on what is required in data handling. Updates to the Second Edition include — A summary of the modifications that data management groups have made under 21 CFR 11, the regulation for electronic records and signatures; Practices for both electronic data capture (EDC)-based and paper- based studies; A new chapter on Necessary Infrastructure, which addresses the expectations of the FDA and auditors for how data management groups carry out their work in compliance with regulations. The edition has been reorganized, covering the basic data management tasks that all data managers must understand. It also focuses on the computer systems, including EDC, that data management groups use and the special procedures that must be in place to support those systems. Every chapter presents a range of successful and, above all, practical options for each element of the process or task. Focusing on responsibilities that data managers have today, this edition provides practitioners with an approach that will help them conduct their work with efficiency and quality. Features Identifies industry standard practices for carrying out data management; Presents multiple ways to complete tasks; Explores standard operating procedures (SOPs) and guidelines and includes a list of common data management SOPs; Contains Data Management Plan, Implementation Plan, and Validation Plan outlines; Describes requirements for clinical data management systems. Contents Elements of the process The data management plan CRF design considerations Database design considerations Study setup Entering data Tracking CRF pages and corrections Cleaning data Managing laboratory data Collecting adverse event data Creating reports and transferring data Locking studies Necessary infrastructure Standard operating procedures and guidelines Training Controlling access and security Working with CROs CDM systems Clinical data management systems Electronic data capture systems Choosing vendor products Implementing new systems System validation Test procedures Change control Coding dictionaries Migrating and archiving data Data management plan outline Typical data management standard operating procedures CRO-sponsor responsibility matrix Implementation plan outline Validation plan outline CDISC and HIPAA Index
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