Acceptance of data from clinical trials for decision-making purposes depends on regulatory agencies’ ability to verify the quality and integrity of the data. As new technology platforms emerge, the responsibility falls to technology providers and sponsors to document their data collection strategy while remaining compliant with regulations.
In this webinar, Steve Begley and Colin Cleary talk about what you should know about eCOA data and regulatory scrutiny. They discuss the areas of eSource regulatory compliance that pose the greatest challenges for an organization, including record keeping of eSource documentation, user roles/access and permission, data review and audit trail management. They also discuss the characteristics of a collaborative sponsor/provider partnership that help ease the burden of compliance while improving inspection readiness.