The Query That Was Closed Without an Answer
A data review of 60 open queries at a site shows that 14 were closed by the site coordinator with the response 'data correct as entered' but the flagged value was not changed and no supporting comment was added. The CRA's monitoring report from the prior month had already noted the same 14 values as 'to be verified against source.' The values in question are adverse event start dates that precede the informed consent date for 9 subjects. The site coordinator says the dates are correct because 'the patient told us the symptoms started before consent, and we recorded what they said.' The sponsor's SOP requires queries to be resolved with a documented response and, where the value is confirmed, a rationale.
1. Are the query closures acceptable? What is the data quality risk?
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Not acceptable. Closing a query with 'data correct as entered' when the flagged issue is a logical inconsistency (AE start before consent) is not a resolution - it is a dismissal. The SOP requires a documented response and, where the value is confirmed, a rationale. Here there is neither a correction nor a rationale.
Data quality risk:
- AE start dates before consent are a protocol and safety signal. If genuine, they may indicate the AE was pre-existing and should be handled per protocol (e.g., recorded as medical history, not as an on-treatment AE). If erroneous, the safety database is wrong.
- The pattern across 9 subjects suggests a systematic issue (site recording pre-existing conditions as AEs, or a date-entry convention), not 9 isolated typos.
- Closing queries without resolution means the data review is cosmetic - the same values will resurface at analysis or inspection.
Action: re-open the 14 queries, require a specific response per value with rationale, and escalate the pattern to the medical monitor and CRA for source review.
2. The coordinator's explanation ('the patient said symptoms started before consent') may actually be clinically meaningful. How should data management handle it?
Read the worked answer
This is the judgment call. The explanation may be correct and important - but it does not resolve the query as written.
Handling:
- Do not force a date change. If the AE truly began pre-consent, altering the date to fit after consent would falsify the record.
- Re-query with the right question: ask the site to confirm whether the event is pre-existing (medical history) or an on-treatment AE, and to document the source basis. The data management issue is classification and rationale, not the date itself.
- Route to the medical monitor for a clinical decision on how these events should be represented per protocol, and to the safety team if they affect reporting.
- Document the resolution with the rationale in the query/audit trail so the decision is reconstructable.
- Check the pattern across the 9 subjects: is this a site convention that needs retraining and a CRF guidance update?
The exam point: a query response must be evaluated for whether it actually addresses the flagged inconsistency. A plausible narrative without classification or rationale is still an open issue, and the data manager must not accept it just because it sounds clinically reasonable.