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Site teams respond to queries raised by the study team. This guide covers how to effectively respond to queries and resolve data issues.

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Who Can Respond

Site team members who can respond to queries:
RoleCan Respond
PIYes
Site AdministratorYes
Deputy PIYes
Sub InvestigatorYes
CRCYes
Data Entry SpecialistYes

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Viewing Open Queries

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Site Dashboard

View all open queries for your site:
  • Total open queries
  • Queries by participant
  • Query age and priority

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Participant Record

View queries on specific records:
  • Navigate to participant
  • See query indicators on fields
  • Click to view query details

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Responding to a Query

1

Open Query

Navigate to the query from dashboard or record.
2

Review Query

Read the query text and understand what’s being asked.
3

Investigate

Check source documents and records.
4

Update Data if Needed

Correct the field value if warranted.
5

Provide Response

Enter response text explaining your findings.
6

Submit

Submit the response.

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Response Types

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Correction

If the data was incorrect:
  1. Update the field value
  2. Explain the correction
  3. Reference source documents
“The original value was a transcription error. I have corrected the blood pressure from 280/160 to 128/86 mmHg per source document dated 15-Jan-2024.”

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Clarification

If the data is correct but unclear:
  1. Leave value unchanged
  2. Explain why the value is correct
  3. Provide supporting context
“The blood pressure reading of 180/110 is confirmed correct. Patient was experiencing acute pain at time of measurement. This was documented in the visit notes.”

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Additional Information

If more data is needed:
  1. Provide the requested information
  2. Add supporting documentation if needed
  3. Reference any relevant context

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Making Data Corrections

When correcting data:
1

Open Edit Mode

The record opens in edit mode when responding to query.
2

Update Field

Change the field value to the correct value.
3

Document Reason

Your query response serves as the reason for change.
4

Save and Respond

Save the change and submit your response.
Data changes made during query response are linked to the query in the audit trail.

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Response Quality

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Good Responses

Characteristics of effective responses:
  • Directly address the query
  • Provide clear explanation
  • Reference source documents when relevant
  • Complete information in one response

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Incomplete Responses

Avoid responses that:
  • Don’t address the question
  • Lack explanation
  • Require immediate follow-up
  • Are vague or unclear

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Query Notifications

Stay informed about queries:
EventNotification
New query raisedEmail and in-app
Query reopenedEmail and in-app
Query closedIn-app

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Query Tracking

Monitor your query workload:
MetricPurpose
Open QueriesCurrent outstanding items
Query AgeHow long queries have been open
Resolution RateQueries closed vs. raised

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After Response

When you submit a response:
  • Query status changes to “Answered”
  • Study team is notified
  • They will review and close or reopen

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If Reopened

If the study team reopens the query:
  • Additional information is needed
  • Review their follow-up comment
  • Provide the requested clarification

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Best Practices

Address queries quickly to maintain study timelines.
Provide complete information to avoid reopening.
Check source documents before responding.
Write clear responses that fully address the query.

Query Lifecycle

Full query workflow.

Participant Records

Managing participant data.