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CLINICAL-TRIALS-BASICS4 MIN READ

Sort data integrity failures

Classify record issues by whether they threaten attribution, contemporaneousness, completeness, or accuracy.

Sort each record problem by the data integrity principle it most directly threatens. Attributable Contemporaneous Complete Accurate and traceable Vital-sign worksheet has no initials or system user tied to the entry Two coordinators use the same EDC login for weekend entry Visit source note is written twelve days after the visit from memory AE start date is reconstructed weeks later without contemporaneous support Infusion record includes start time but no stop time Eligibility checklist leaves required pregnancy test result blank Original blood pressure value is overwritten with no correction reason Lab value is entered in the wrong unit and corrected…

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