eCOA Risk Management In The Digital Age

By Aubrey Llanes, Product Director, eCOA

Regulators across the globe are urging industry to strengthen their data integrity practices. Good risk mitigation and management is essential to data integrity, as many points of risk exist throughout the data lifecycle of a clinical trial. From the capture of endpoint data through data recording, storage, transfer, and reporting, eClinical systems introduce risk to data integrity that must be managed by documenting eClinical data processes and by making them transparent and traceable through audit trails.

Risk management begins by asking three basic questions:

• What might go wrong?
• What is the likelihood that it will go wrong?
• What are the consequences if it does go wrong?