Even when allrangeandlogic checksare successfully resolved, discrepancies may still exist between theclinical databaseand thesource documents. This typically indicates anerror in data abstraction or transcription, meaning that data were incorrectly entered or extracted from the source records during the data entry or verification process.
According to theGood Clinical Data Management Practices (GCDMP, Chapter on Data Validation and Cleaning),data validation rulessuch as range and logic checks are designed to identify inconsistencies, missing data, or out-of-range valueswithin the databaseitself. However, they donot verify the accuracy of data entry against the original source documents— that responsibility falls undersource data verification (SDV), typically conducted by clinical monitors or auditors.
When an auditor detects discrepancies between source and database values after all edit checks have passed, the most probable explanation is thatdata were not transcribed correctly from the source, rather than a failure in programmed edit checks. This could occur due to human error during manual data entry, misinterpretation of the source document, or oversight during SDV.
OptionC (Data were changed after checks were run)might occur in rare cases but would normally be documented in an audit trail per21 CFR Part 11andICH E6 (R2)standards. OptionBmisinterprets the issue, since “logical and in range” values can still be incorrect relative to the source. OptionA (Auditor error)is possible but statistically less likely, as source data verification follows strict, documented audit procedures.
Therefore, themost likely reasonfor such discrepancies isOption D: Data were not abstracted correctly from the source, emphasizing the importance of robust data entry training, dual data entry, and verification procedures.
Reference (CCDM-Verified Sources):
Society for Clinical Data Management (SCDM), Good Clinical Data Management Practices (GCDMP), Chapter: Data Validation and Cleaning, Section 6.5 – Source Data Verification and Reconciliation
ICH E6 (R2) Good Clinical Practice, Section 5.18 – Monitoring and Source Data Verification
FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6 – Source Data Accuracy and Audit Trails
21 CFR Part 11 – Electronic Records and Electronic Signatures, Subpart B: Audit Trails and Record Accuracy
