In a discrepancy management workflow,“Received from site and not yet reviewed”isnot a resolution type— it represents astatus, not a final resolution outcome.

According to theGCDMP (Chapter: Data Validation and Cleaning), resolution types describe how a data discrepancy was finalized or addressed, such as:

Resolved with data correction,

Confirmed as correct (no change required),

Self-evident correction applied by data management, or

Unresolvable discrepancies documented.

In contrast,statusesdescribe the stage of the query (e.g., open, sent, answered, pending review, closed). “Received from site and not yet reviewed” indicates anintermediate workflow statewhere the response awaits validation by data management.

Proper classification of resolution types is essential for performance reporting, audit readiness, and ensuring the traceability of query management actions underICH E6 (R2)andFDA 21 CFR Part 11.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Validation and Cleaning, Section 5.3 – Discrepancy Resolution Lifecycle

ICH E6 (R2) Good Clinical Practice, Section 5.5.3 – Data Handling and Record Management

FDA 21 CFR Part 11 – Electronic Records; Audit Trails and Discrepancy Tracking Requirements