Queries

Automatic and manual queries, answers, closing and reopening, the query list.

A query is a question about a value in a form. It is opened by an edit check or by a person, answered by the site and closed by the monitor or data manager.

The life cycle of a query. A closed query can be reopened; an automatic query closes by itself once the value is corrected.

Where queries come from

• Automatic check: a value outside the expected range, or an edit check with the warning severity. The query opens when the form is saved.
• Monitor, data manager or project administrator: a question about a field, asked from the form (New query on the right of the form).

The life of a query

1. Awaiting answer: the investigator sees a red counter at the field, in the visit matrix and in the patient card.
2. Answered: the investigator has written what was checked or corrected.
3. Closed: the monitor or data manager agrees with the answer. An automatic query closes by itself when the value is corrected.

A closed query can be reopened with a comment. The whole conversation is kept, and every step is in the audit trail.

The query list

The Queries section shows the queries of the study at your sites by status: Awaiting answer, Answered, Closed. The oldest come first. Filter by source, site, patient ID and age: up to 3 days, 3 to 7 days, older than 7 days. The red number next to Queries in the menu is the count of open queries; it turns urgent when some are older than a week.

A confirmed value stays confirmed

When the site confirms a value that an automatic check questioned and the monitor or data manager closes the query, the check stays quiet: saving the form again, an import or a new ePRO answer with the same values do not open the same query again. The query remembers what its check read when it was closed: the value of the field, and for an edit check also the compared field and the fields of its condition or formula (for a lab result, the previous visit's result too). As soon as one of these values changes, the check looks at it afresh and opens a new query if it still fires. A value that was corrected and later typed back is also checked afresh.

• A query that closed by itself because the value was corrected is not a confirmation: the same wrong value typed again is queried again.
• Queries closed before this version have no such memory. They count as confirmed while a save does not change the values their check reads, and take the memory at that save.
• A check kept quiet writes nothing to the audit trail: the closing of the query, who closed it and why, is already there.

Standard query texts

The study keeps a library of standard texts for queries: the data manager or the project administrator opens it from the Queries list (Standard query texts) or from the study settings. A new study gets a small default set the first time the library is opened: confirm the value, value missing, differs from the source, date out of sequence, check the unit. Each text has a Russian and an English version and may use the placeholders {field} (the field's label), {value} (its saved value with the unit), {visit} and {form}. A placeholder the library does not know is refused when the text is saved. Every text added, changed or deleted is in the audit trail with its old and new wording.

A monitor or data manager raising a query on the form picks a text under the field list: the placeholders are filled for the chosen field, in the language of the person raising it, and the text can still be edited before Raise the query. While the text is not edited, choosing another field fills it again.

The study's standard query texts: Russian and English side by side, the placeholders on the right.

Closing many queries at once

On the Queries list, whoever may close queries (monitor, data manager, project administrator) ticks queries on the Awaiting answer or Answered tab, or All on the page, writes one reason and presses Close selected. The bar shows how many are selected, and the portal asks to confirm before closing. Each query is closed on its own: the reason goes into its conversation and into its own audit record. Only queries of your sites and of the forms you may see are closed; anything else is left as it is, and the portal says how many were not closed.

Queries ticked for closing, with one reason for all of them.

Who does what

• Investigator: answers the queries of their sites.
• Monitor and data manager: raise, close (also many at once) and reopen queries.
• Data manager and project administrator: keep the standard query texts.
• Project administrator: all of the above.

Example from the demo

In REG-DIAB-01 the monitor Igor Smirnov compared the visit date of REGDIA-01-0001 at Month 3 with the outpatient record and raised query Q-0017 on the Visit date field: “The date does not match the visit date in the outpatient record.” Anna Petrova sees it next to the field, checks the record and answers; Igor then closes the query, or reopens it with a comment if the answer does not settle it.

The open queries of REG-DIAB-01, the oldest first.

Query Q-0017 next to the form: the investigator writes the answer.