In aCRF-to-database quality control (QC) audit, auditors compare data recorded on the paper Case Report Form (CRF) with data entered in the electronic database. If discrepancies exist thatcannot be explained by documented data handling conventions, they are classified asaudit findings.

PerGCDMP (Chapter: Data Quality Assurance and Control),data handling conventionsdefine acceptable data entry practices, transcription rules, and allowable transformations. These conventions ensure that CRF data are consistently interpreted and entered.

If a discrepancy deviates from these established rules, it indicates a process gap or error in data entry, validation, or training. Discrepancies justified by protocol design or CRF guidelines would not constitute findings.

Therefore,option C (Discrepancy not explained by the data handling conventions)correctly identifies the criterion for a true QC audit finding.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Data Quality Assurance and Control, Section 6.1 – Data Handling Conventions and QC Auditing

ICH E6(R2) GCP, Section 5.1 – Quality Management and Documentation of Deviations

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.5 – Data Verification and Audit Findings