Edit checks and queries

Review status

Included in the proposed model: Edit Check Definition, Check Evaluation, Validation Finding, Data Query, Query Message, Query Routing, Query Escalation, Query Reconciliation, and Query Metrics.

Settled proposal: a failed edit check and a query are different records. A check may pass on a later run; the site conversation remains traceable.

Open: automatic query closure policies, duplicate-query suppression, and cross-source issue ownership.

Clinical purpose

Data cleaning finds missing, inconsistent, implausible, or out-of-range data and resolves the issue with the people responsible for the report. The product must explain what was detected, which data were involved, what was asked, how the site responded, and why the issue was closed or reopened.

Edit Check Definition

Field	Meaning
Check identifier and version	Stable identity for traceability and amendment
Clinical intent	Plain explanation of the discrepancy being detected
Inputs	Exact items/events and occurrence selectors used
Evaluation scope	Item, row, form, event, subject, or cross-form context
Trigger	Entry, submit, import, batch, amendment, or source correction
Condition	Data-type-checked rule that can pass, fail, or be indeterminate
Severity	Informational, warning, error, or study-defined criticality
Query target and text	Data point/person the question is directed to and approved wording
Suppression policy	Missing/unknown cases or existing conversations that should not create another query
Effective design/build	Version under which the check applies

Check wording should be actionable and neutral. It asks for clarification or correction; it does not accuse a site of error.

Check Evaluation

Every meaningful run records:

check and version;
subject and evaluation scope;
exact input revisions;
trigger and evaluation time;
result: passed, failed, or could not evaluate;
explanation and calculated values;
resulting finding/query action; and
superseded evaluation when inputs or rules later change.

“Could not evaluate” is important when an input is missing, partial, blinded, or not yet imported. It is not the same as pass.

Validation Finding

A finding is the current detected discrepancy for one check and clinical origin. It contains:

first and latest failing evaluations;
current condition: present, resolved by data, obsolete after rule change, or accepted exception;
severity;
related query, if one was opened;
reconciliation reason; and
full evaluation history.

The finding permits deterministic reevaluation without treating each batch run as a new human conversation.

Data Query

Field	Clinical meaning
Query number	Stable recognizable identity
Origin	Manual or system-generated
Target	Item, row, form, event date, subject, or other approved clinical origin
Related finding/check	Present for automatically generated queries
Category and priority	Study-defined cleaning classification
Initial question	Approved text and clinical context
Opened by/at	Person/system and time
Assigned responder	Usually the accountable site role
Responsible reviewer	Monitor, data manager, coder, or external-data reviewer accountable for disposition
Routing	Current site/role/person queue, route reason, routed by/at and routing history
Due and escalation	Due date, service expectation, escalation level, escalated to/by/at and reason
Current status	Open, Answered, Closed, or Cancelled
Messages	Ordered question, response, re-query, and closure explanations
Related revisions	Data changes that may address the query
Closure evidence	Reviewer, time, outcome, and rationale

Status journey

Open
→ Answered by site
→ Closed by reviewer

Answered
→ Returned to site / Re-queried
→ Answered again

Closed
→ Reopened, with reason

Open / Answered
→ Cancelled because created in error, duplicated, misrouted, or made obsolete

An answer does not prove resolution. The monitor, data manager, coder, or other authorized reviewer decides whether the response and current data resolve the question.

Query Message

Messages are append-only and retain:

author and accountable role;
author organization/site;
time;
message type: question, response, re-query, closure explanation, reopen explanation;
text or approved template version;
attachments/references when allowed;
data revision current when the message was sent; and
originating system for cross-system queries.

Editing old message text is not permitted. A correction is another message.

Actions

Action	Result
Evaluate check	Pass/fail/indeterminate evaluation and finding reconciliation
Open manual query	New conversation at a stable clinical target
Open system query	New conversation linked to failing check/finding
Answer query	Site response; may also reference a data correction
Return/re-query	Reviewer asks for further clarification
Close query	Reviewer concludes no further action is required
Reopen query	Closed conversation becomes active with reason
Route/reassign query	Moves accountability with reason while retaining routing history
Escalate query	Records overdue/critical escalation without changing the clinical question
Cancel query	Ends a query that should not be resolved as a clinical discrepancy; reason required
Accept known discrepancy	Documents why current data remain as reported
Mark finding obsolete	Rule/amendment no longer regards it as a current discrepancy

Business rules

Every query has one stable target and ordered conversation.
A query status change never overwrites prior messages or states.
Changing a value does not automatically count as a query answer.
Answering a query does not automatically change clinical data.
Automatic closure, if allowed, is a named study policy and remains audited.
A later passing check may resolve the finding but does not erase the query conversation.
Manual queries are not closed merely because no current automated failure exists.
A rule change records previous findings as obsolete/reconciled; it does not rewrite history.
The system suppresses duplicate automatic queries according to an explicit origin-and-condition policy.
Frozen data may still permit query discussion; locked data require controlled reopen before correction.
Query metrics derive from query history and never become the authoritative query record.
Blinding restrictions apply to query text, target visibility, messages, and exports.
Closing means the clinical question was dispositioned; cancelling means the query should not have continued as a valid question.
Routing and escalation never rewrite the query author, target, messages, or prior accountability.
A cancelled system query does not erase its originating finding or check evaluation.

Query aging and operational views

Useful read-only views include:

open queries by site, subject, age, category, and priority;
answered queries awaiting sponsor review;
re-queried items awaiting site response;
closed and reopened query history;
system versus manual queries;
queries affected by later data changes;
queries on frozen or locked scopes; and
average time to first response and final closure.

Age calculations state whether they use calendar or business days and which status intervals are counted. The view does not change query meaning.

Exceptions

A required value is intentionally unavailable with an accepted missing-data reason.
An out-of-range value is correct and the site confirms it without changing the value.
A site corrects the data but does not answer the query.
A site answers but the response does not resolve the discrepancy.
Two checks would open equivalent queries on one datapoint.
A monitor opens a manual query while a system query is already open.
A query closes, then another datapoint correction makes it relevant again.
An amendment removes or changes the originating check.
An external-data discrepancy must be answered by a laboratory rather than the site.
A coding query needs indication or route clarification without changing the verbatim term.
A query was opened against the wrong site and must be rerouted without losing aging history.
A critical safety-related query exceeds its response time and escalates to the investigator and study lead.
A duplicate query is cancelled while the original conversation remains active.

Audit and handoffs

The query audit must reconstruct the data state, check version, messages, actors, status changes, and closure rationale. Coding and external-data systems may initiate queries through an explicit contract, but EDC retains the site-facing conversation when EDC is the chosen query channel.