Whenlaboratory dataare missing from a paper-based clinical study, theData Managershould directdata-entry personnel to issue a queryto the investigative site for clarification or correction.
According to theGood Clinical Data Management Practices (GCDMP, Chapter: Data Validation and Cleaning), every missing, inconsistent, or out-of-range data point must be reviewed and, if necessary, resolved through the formalquery management process. This ensures that all discrepancies between the source documents and database entries are properly documented, traceable, and auditable.
Data-entry staff arenot authorizedto infer or fill in missing information. They must escalate such discrepancies to the site via query, preservingdata integrityandregulatory compliancewithICH E6 (R2)andFDA 21 CFR Part 11. Calling the patient directly (option B) would violate confidentiality and site communication protocol, while simply flagging or ignoring the issue (options A and D) would not meet GCDMP query resolution standards.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Validation and Cleaning, Section 5.2 – Query Management and Resolution
ICH E6 (R2) Good Clinical Practice, Section 5.18.4 – Communication of Data Discrepancies
FDA 21 CFR Part 11 – Electronic Records; Query Audit Trails Requirements
