ALCOA+ stands for Attributable, Legible, Contemporaneous, Original, and Accurate, as well as Complete, Consistent, Enduring, and Available— the fundamental principles of data integrity in clinical trials. These criteria, developed by the FDA, define how clinical data must be captured, processed, and archived to meet regulatory standards.
Implementing the ALCOA+ principles in CRO operations requires robust systems and processes. “Attributable” means that every data change can be assigned to a specific user. “Legible” ensures the lasting readability of all data. “Contemporaneous” requires the prompt documentation of events. “Original” refers to the first record or an exact copy. “Accurate” requires error-free data capture.
The extended principles (the “Plus”) address modern challenges in digital data processing. “Complete” means that all required data are present. “Consistent” requires uniform formats and procedures. “Enduring” ensures the long-term integrity and availability of data throughout the entire archiving period. “Available” ensures that data are accessible to authorized persons. CROs must integrate these principles into their eCRF systems, data management processes, and archiving strategies.