Overview

The Queries app manages data clarification, annotations, reason for change, and failed validation queries. The configuration interface allows you to pre-define common descriptions and reasons that will be available to data entry staff when they update, close, or provide reasons for changes on queries and CRFs.

Path: Home → Study Name → Apps → Queries → Configuration

Configuration URL: https://[instance]/home/study/[studyId]/apps/query

note

Queries configuration requires the study to be in Design status. If the study is in Available or Frozen status, settings are read-only.

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Configuration Access & Status

• Who Can Configure: Study administrators and users with Queries app configuration permissions
• When to Configure: During study setup in Design phase
• Study Status Requirements:
  • Edit Allowed: Study in Design status
  • Read-Only: Study in Available or Frozen status

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Pre-defined Description Lists

Update Query Descriptions

Define a list of common descriptions available when updating a query of type "Query".

Purpose: Provide consistent, standardized response templates when data is questioned or clarified. Data entry staff can select from these pre-defined options or type custom text.

"This is a pre-defined list to be selected when user updates an existing Query. User can also easily type new content at that time."

Table Columns

Column	Description
Description	The pre-defined text to appear as a selection option when updating a query
Visibility Level	Who can see and use this description: Site Level, Study Level, or Both

Visibility Levels Explained

• Site Level — Description is visible only to users at a specific site; useful for site-specific issues
• Study Level — Description is visible to all users across all sites in the study
• Both — Description is available at both site and study levels for maximum flexibility

Adding/Editing Update Descriptions

1. Click Add or the edit button on an existing row
2. Enter the description text (e.g., "Data verified at source", "Subject clarified issue")
3. Select the appropriate Visibility Level
4. Click Save to confirm

How It Works in the Queries App

When a staff member opens a query and clicks Reply, a form appears with a Description dropdown. The options in that dropdown are exactly the descriptions configured in this section — staff can select one with a single click instead of typing free text every time.

Staff can also type custom text directly into the Description field if none of the pre-defined options fits the situation.

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Close Query Descriptions

Define a list of common descriptions available when closing a query of type "Query".

Purpose: Standardize the reasons for closing queries (e.g., data confirmed, data corrected, no action needed). This improves audit trail consistency and data quality documentation.

"This is a pre-defined list to be selected when user closes an existing Query. User can also easily type new content at that time."

Table Columns

Column	Description
Description	The pre-defined text for the close/resolution reason
Visibility Level	Site Level, Study Level, or Both

Common Close Reasons

Examples of typical close descriptions:

• "Data verified at source"
• "Corrected in CRF"
• "Clarified by subject"
• "No action required"
• "Duplicate query"
• "Query resolved"

Adding/Editing Close Descriptions

1. Click Add or edit an existing row
2. Enter the closure reason text
3. Select Visibility Level (Site Level, Study Level, or Both)
4. Click Save

How It Works in the Queries App

When a staff member clicks Close on a query, a similar form appears. The Description dropdown will show the options configured in this section — separate from the Reply descriptions so that closure reasons are clearly distinguished from update responses.

Staff can still type a custom close reason if none of the pre-defined options applies.

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Reason for Change Descriptions

Define a list of common descriptions for Reason for Change (RFC) when updating or correcting a completed CRF.

Purpose: Provide standardized reasons for any changes made to verified or locked CRF data. This maintains a clear audit trail and explains data modifications post-completion.

"This is a pre-defined list to be selected when user provides a reason for change in case updating a complete CRF. User can also easily type new content at that time."

Table Columns

Column	Description
Description	The pre-defined RFC text explaining why data was changed
Visibility Level	Site Level, Study Level, or Both

Common Reason for Change Scenarios

• "Subject clarified value"
• "Data entry error corrected"
• "Source document update"
• "Unit conversion applied"
• "Protocol deviation resolved"
• "Regulatory requirement"

Adding/Editing Reason for Change Descriptions

1. Click Add or edit an existing row
2. Enter the reason for change text
3. Select Visibility Level
4. Click Save

How It Works in the Queries App

When a staff member edits data in a completed CRF (i.e., a CRF that has already been saved or signed), the system requires a Reason for Change before the edit can be submitted. A dialog appears with a Description dropdown populated from this section.

Pre-defined RFC descriptions ensure:

• Consistent audit trail language across all data corrections
• Faster data entry for routine corrections
• Regulatory-compliant documentation of data changes

Staff can also type a free-text reason if the situation is not covered by the pre-defined list.

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Configuration Workflow

Step-by-Step: Adding a New Description

1. Navigate to Configuration

   • Go to your study → Apps → Queries → Configuration

2. Select the Section

   • Choose between:
     • Update Query Descriptions
     • Close Query Descriptions
     • Reason for Change Descriptions

3. Add New Entry

   • Click the Add button in your chosen section
   • Enter the description text
   • Select visibility level (Site Level, Study Level, or Both)

4. Save Configuration

   • Click Save settings at the bottom of the page
   • Changes take effect immediately

5. Verify Results

   • Open the Queries app to confirm descriptions appear in dropdown menus

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Saving & Discarding Changes

Action	Effect
Save settings	Applies all configuration changes to the study
Discard changes	Reverts any unsaved edits

Important: Changes must be explicitly saved. Unsaved changes are lost if you navigate away from the configuration page.

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Best Practices

• Consistency: Use clear, standardized terminology across all description lists
• Brevity: Keep descriptions concise but descriptive (2-5 words recommended)
• Site-Specific Needs: Use Site Level visibility for site-specific workflows; use Study Level for standardized processes
• Regular Review: Audit your description lists quarterly to remove obsolete entries
• Documentation: Maintain a reference document of your organization's standard descriptions
• Pilot Testing: Test configurations with a small group of data entry staff before full rollout