Data Entry, Validation, and Query Management
What you must know
Data entry moves source data into the EDC. Validation uses edit checks to flag discrepancies. Queries are formal requests to resolve discrepancies, tracked from open to closed. Understand the query lifecycle: system-generated or manual query, sent to site, response entered, query closed, and audit trail captured.
Concepts to master
Know the difference between hard and soft edit checks: hard checks prevent saving; soft checks allow saving with a query. Understand automatic query generation versus manual review queries. Recognize the importance of query aging and metrics for oversight. Know that source data verification (SDV) is a monitoring activity, not a data management one, though both use the same records.
Traps
Questions confuse an edit check with a query, or imply that a closed query means the data are correct. Watch for wording that treats a soft check as blocking. Another trap: assuming queries can be deleted rather than closed with documentation.
Rule of thumb
Every query needs a documented resolution and an audit trail entry. If a discrepancy is resolved without a query, ask whether the resolution is traceable.