Module 12 2019

HISTORY OF EDC

➢ LONG (sometimes painful) history of what began as “remote data entry” (RDE) ➢ Began back in the 1980’s when desktop computers came into existence ➢ Similar situation to US CANDAs where each study had it’s 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