part part one. Elements of the process -- chapter 1 The data management plan -- chapter 2 CRF design considerations -- chapter 3 Database design considerations -- chapter 4 Study setup -- chapter 5 Entering data -- chapter 6 Tracking CRF p. and corrections -- chapter 7 Cleaning data -- chapter 8 Managing laboratory data -- chapter 9 Collecting adverse event data -- chapter 10 Creating reports and transferring data -- chapter 11 Locking studies -- part part two. Necessary infrastructure -- chapter 12 Standard operating procedures and guidelines -- chapter 13 Training -- chapter 4 teen. Controlling access and security -- chapter 15 Working with CROs -- part part three. CDM systems -- chapter 6 teen. Clinical data management systems -- chapter 17 Electronic data capture systems -- chapter 18 Choosing vendor products -- chapter 19 Implementing new systems -- chapter 20 System validation -- chapter 21 Test procedures -- chapter 22 Change control -- chapter 23 Coding dictionaries -- chapter 24 Migrating and archiving data.