Module 12 Presentations

Challenges OF EDC

• Poor acceptance at sites

• Change in process; perceived as more work for Study Coordinators

• Same data “cleanliness” issues existed

• RDE systems were not intuitive

• Glorified paper

• No time savings

• Time saved at the back end was lost in the front

• Technology in its infancy

• Not globally feasible

The Organisation for Professionals in Regulatory Affairs