Module 12 Presentations

HISTORY OF EDC

• LONG (sometimes painful) history of what began as “ remote data entry ” (RDE)

• Began back in the 1980s when desktop computers came into existence

• Similar situation to US CANDAs where each study had its own computer and software • Computers placed at sites where data was entered by clinical study staff and then “sent” to sponsor or CRO • The industry assumed there would be HUGE benefits and accelerated drug development timelines

The Organisation for Professionals in Regulatory Affairs