In reviewing the adverse events for a subject, a data manager notices one recorded as...

When adata inconsistencyarises — such as a record of “worsening of migraine” without prior documentation of a migraine episode — the Data Manager shouldquery the site for clarification(Option D).

According to theGCDMP (Chapter: Data Validation and Cleaning), data managers must raise aclarification querywhenever data appear incomplete, inconsistent, or ambiguous. The site must confirm whether “worsening of migraine” refers to anew eventor anexacerbation of a preexisting condition. This clarification ensures accurate safety reporting and appropriate medical coding (e.g., MedDRA classification).

Checking the medical history (Option C) may help but does not resolve the inconsistency. Assuming a relationship (Option A or B) without verification would violateGood Clinical Data Management Practiceand potentially misrepresent the adverse event.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Validation and Cleaning, Section 6.3 – Query Generation and Resolution

ICH E2A – Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, Section II – Data Clarification Requirements

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations – Data Query Management