CLiREN-LMS
Foundations of Clinical Research Data Management

Characteristics of High-Quality Data

Table 1

30-45 minutes Foundational Step 6 of 7
Table

Table 1

6 / 7
Table

Table 1

CharacteristicMeaningClinical research example
AccuracyData reflect the true observed or documented valueWeight entered as 12.5 kg when the source record shows 12.5 kg
CompletenessRequired data are present or missingness is explainedAll enrolled participants have a recorded primary outcome or a documented reason for missing outcome
ConsistencyRelated values agree logicallyDate of follow-up occurs after date of enrollment
TimelinessData are available when neededSite enters follow-up forms within three days of participant visit
ValidityData follow defined rules and formatsTemperature is numeric and within the allowed range
ReliabilityMeasurement is repeatable under similar conditionsBlood pressure measured using a standardized procedure
IntegrityData are protected from unauthorized or undocumented changeAudit trail records user, timestamp, old value, and new value