Module 12 2019

Challenges OF EDC

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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

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No time savings ➢ Time saved at the back end was lost in the front

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Technology in its infancy

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Not globally feasible

The Organisation for Professionals in Regulatory Affairs