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All Clinical Data Management questions

Question 5 of 6 Advanced Concept

What must be reconciled when importing central laboratory results?

Short answer

Link each received result to the correct subject, visit, specimen, analyte, unit, status and source version, and resolve missing, duplicated or revised values before downstream use.

Why

An external laboratory sends a new file with repeat measurements and amended results. Reconcile expected versus received sample IDs, collection times, accession identifiers, protocol visits, analyte codes, units, reference ranges and data states such as cancelled or corrected. Ensure identifiers match across de-identified site and laboratory systems without exposing unnecessary patient information.

Confirm that retransmissions do not create duplicate observations and that superseded results remain traceable. Detect unit conversion issues, for example mmol/L versus mg/dL where the conversion is analyte-specific. Compare record counts, changes and key exceptions to the prior load, document query resolution and verify that mapping to standardized datasets preserves meaning.

A successful file import with no technical errors does not prove complete clinical reconciliation.

Common mistakes

  • Accepting a technically valid CSV as fully reconciled without checking amended results and specimen identity