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. 2022 Jan 17;5(1):ooab119. doi: 10.1093/jamiaopen/ooab119

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© The Author(s) 2022. Published by Oxford University Press on behalf of the American Medical Informatics Association.

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

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Figure 5. — ATRI EDC integrated eCRF-Query-Audit Trail interface. This novel interface integrates multiple data sources—eCRF, source document verification (SDV), record locking, eCRF- and item-level queries, eCRF- and item-level audit trail, and eCRF version and revision information. It supports accurate and timely communication and collaboration between study teams and sites by offering a shared view of these data sources and a conversational interface for data query creation and resolution. Panel A demonstrates the primary eCRF interface, which includes the following features: (1) case navigation and orientation, (2) 1-click eCRF-level query and audit trail review, (3) eCRF version and language settings, (4) dates of last modification and SDV, (5) various input types with accompanying prompt, units, notes, and 1-click item-level query and audit trail review, (6) real-time item-level error feedback with query integration, (7) item indenting, missing data check box, and skip patterns, (8) color-coded action buttons, (9) integrated query listing, details, and creation, (10) conversational query interface, (11) query comments, response, and closure, (12) query conversation history, and (13) field navigation, orientation, and query status. Panel B demonstrates the integrated Audit Trail interface, which includes the following features: (14) summary and detailed view of eCRF insert, (15) summary and detailed view of eCRF update with item-level change summary and query status, (16) eCRF update with resolved query status, and (17) SDV summary.