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
Biography
Susanne Prokscha is an Independent Consultant working with Genentech in South San Francisco, California.
