The slide "Documentation & Source Data" is a table outlining ALCOA requirements for key elements like Case Report Forms (Attributable, Legible, Contemporaneous, Original, Accurate), Source Documents (Original, Legible, Contemporaneous, Complete), Investigator Notes (Signed, Dated, Attributable), and Imaging & Test Results (Accurate, Consistent, Available). It emphasizes data integrity standards for clinical documentation.
Documentation & Source Data
{ "headers": [ "Elements", "ALCOA Requirements" ], "rows": [ [ "Case Report Forms (CRFs)", "Attributable, Legible, Contemporaneous, Original, Accurate" ], [ "Source Documents (charts, labs)", "Original, Legible, Contemporaneous, Complete" ], [ "Investigator Notes", "Signed, Dated, Attributable" ], [ "Imaging & Test Results", "Accurate, Consistent, Available" ] ] }
Speaker Notes
Ensures trial integrity through adherence to ALCOA principles for all documentation elements.