Prokscha S. Practical Guide to clinical data management

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.FeaturesIdentifies 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.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