ABSTRACT

The management of clinical data, from its collection 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. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s t

part |2 pages

part one. Elements of the process

chapter 1|6 pages

The data management plan

chapter 2|10 pages

CRF design considerations

chapter 3|16 pages

Database design considerations

chapter 4|8 pages

Study setup

chapter 5|10 pages

Entering data

chapter 6|8 pages

Tracking CRF pages and corrections

chapter 7|14 pages

Cleaning data

chapter 8|14 pages

Managing laboratory data

chapter 9|10 pages

Collecting adverse event data

chapter 10|8 pages

Creating reports and transferring data

chapter 11|8 pages

Locking studies

part |2 pages

part two. Necessary infrastructure

chapter 12|10 pages

Standard operating procedures and guidelines

chapter 13|6 pages

Training

chapter 4|6 pages

teen. Controlling access and security

chapter 15|8 pages

Working with CROs

part |2 pages

part three. CDM systems

chapter 6|4 pages

teen. Clinical data management systems

chapter 17|10 pages

Electronic data capture systems

chapter 18|8 pages

Choosing vendor products

chapter 19|8 pages

Implementing new systems

chapter 20|8 pages

System validation

chapter 21|6 pages

Test procedures

chapter 22|6 pages

Change control

chapter 23|10 pages

Coding dictionaries

chapter 24|6 pages

Migrating and archiving data