OpenClinica Reporting and Analytics

Modified on Wed, 22 Jul at 7:59 AM

This page introduces OpenClinica Reporting and Analytics, a reporting and visualization module that enables you to explore, analyze, and share your study’s clinical and operational data through interactive dashboards and reports.

Once Reporting and Analytics is enabled for your study, contact support@openclinica.com to schedule a demo and learn how to optimize data insights for your organization.

ℹ️ Note: This module is not available on the Launch plan.

Overview

Tip: Watch OpenClinica Reporting and Analytics - What could you do with intelligent reporting from OpenClinica, LLC on Vimeo to see example use cases and dashboards.

OpenClinica Reporting and Analytics provides intelligent reporting and visualization tools that help you gain actionable insights into your study data. It allows you to:

Create and customize dashboards to monitor study progress
Build reports to track enrollment, adverse events, and form completion
Share and embed reports across teams or external systems

Accessing Reporting and Analytics

OpenClinica Reporting and Analytics is available as an optional module for OpenClinica 4. It is hosted separately from Study Runner and requires its own user access.

User permissions in Reporting and Analytics are independent of Study Runner unless your organization has enabled Row-Level Security (RLS).

It is hosted on a separate URL and requires a separate login.

To determine whether your organization has Reporting and Analytics:

Check with your OpenClinica Administrator or click here.
Or refer to your module list in the system.
If you are an administrator, see Module Management for configuration details.

After Reporting and Analytics is enabled:

Navigate to your study in OpenClinica.
Select Reporting and Analytics Reports from the study navigation bar.
The Reporting and Analytics interface will open in a new window.

ℹ️ Note: Access to the Reporting and Analytics module is managed separately from Study Runner. Granting a user Reporting and Analytics access allows them to view study data in Reporting and Analytics according to your organization’s security configuration (see Data Access and Permissions below).

However, visibility of the Reports section in the Study Runner Tasks menu is controlled within Study Runner using the Show Reports Link role permission.

Getting Started

Reporting and Analytics provides built-in reports and interactive tools for building your own analyses without complex setup.

Key Concepts

Questions:
Reports in Reporting and Analytics are called Questions. You can create them using a visual Question Builder or by writing SQL queries.
- The Question Builder supports filters, aggregation, grouping, and chart or table views.
- Save Questions to reuse or share them with colleagues.
Dashboards:
Dashboards display multiple Questions on one page.
- Arrange Questions on a grid, resize panels, and apply filters to specific or all Questions.
- Drill down into tables or graphs for more details.
Pulses and Alerts:
Configure automated notifications that send report results to team members—either on a schedule or triggered by data changes.
Data Reference:
Use the Data Reference section to explore table and column definitions generated from your study metadata.
Administrators can customize these descriptions.

ℹ️ Note: The Reporting and Analytics interface runs on Metabase software. For detailed instructions on creating Questions, setting alerts, managing users, and permissions, refer to the Metabase User Guide.

Reporting and Analytics Data Warehouse

Reporting and Analytics’s foundation is a data warehouse built from your OpenClinica transactional database using PostgreSQL and Python.

Each warehouse includes:

A schema for each study environment
Tables representing CRFs and Item Groups, with items as columns
Audit logs and non-removed data
A constellation data model optimized for reporting
For more information on constellation data model, refer to constellation.
Automated snapshot updates (default refresh every hour, configurable as needed)

Data Access and Permissions in Reporting and Analytics

By default, OpenClinica Reporting and Analytics assigns permissions using a feature called integrated Row-Level Security or RLS. RLS, which integrates privileges between OpenClinica itself and Reporting and Analytics, became the default method for assigning Reporting and Analytics privileges in the Stack 19 release (March, 2024). Any study started before that date will have RLS disabled unless you have chosen to opt it in. You can opt any study started after that time OUT of using RLS by contacting the OpenClinica support team.

When RLS is enabled:

Reporting and Analytics automatically limits data visibility to match the user’s permissions in Study Runner.
Users only see data from the forms, events, or sites to which they have access (based on study access, site access, and assigned Permission Tags. All form access levels except No Access will be considered by Reporting and Analytics as having access to the form.).

When RLS is not enabled:

Access to each data mart in the Reporting and Analytics data warehouse, and all Questions, Dashboards, and other reports created in Reporting and Analytics, must be managed manually in the Reporting and Analytics Admin menu.

Controlling Visibility of the Reporting and Analytics Reports Link in Study Runner

Allow you to configure which study roles can see the Reports (Reporting and Analytics) option in the Tasks menu.

Show Reports Link Permission

Each role includes a new permission called Show Reports Link. This permission determines whether users with that role can see the Reports section in the Tasks menu.

Where to Find This Permission

Go to Settings → User Roles.
Click Edit next to an existing role.
In the Module Permissions section, expand Reporting and Analytics Module.
Select Show Reports Link.

Default Behavior

The Show Reports Link permission is disabled by default for all roles.
Users cannot see the Reports link unless a Data Manager enables this permission.

Custom Roles

When you create a custom role, the Show Reports Link option appears in the role creation dialog, regardless of the base role you select.

Interaction with Reporting and Analytics Activation

If your organization deactivates and later reactivates Reporting and Analytics, the system does not restore prior role configurations. You may need to re-enable the Show Reports Link permission for the appropriate roles.

Advanced Capabilities

Data Sharing and Integration

You can:

Share and embed Questions or Dashboards directly through the Reporting and Analytics interface
Integrate Reporting and Analytics with your organization’s analytics or reporting tools
Access data warehouse content directly or via the Metabase API (contact OpenClinica Support for assistance)

Learn More About Reporting and Analytics

Take a deeper dive into Reporting and Analytics to explore its full capabilities and advanced reporting features.

You can:

Review the Reporting and Analytics Overview Slides to learn how to:
- Track enrollment
- Monitor adverse events
- Identify missing forms
- Understand the data model and architecture
- Explore advanced Question Builder features
Watch the Reporting and Analytics Webinar Recording a one-hour demonstration of Reporting and Analytics’s reporting tools and configuration options.

Tip: Use these resources to enhance your familiarity with Reporting and Analytics’s data structure and reporting workflows.

Customizing Your Dashboard

You can configure your Reporting and Analytics dashboard to control how information is displayed and organized.

To customize your dashboard:

Display multiple Questions at the same time
Arrange dashboard panels on a flexible grid layout
Resize and reposition panels to highlight key metrics
Apply filters to one, several, or all Questions simultaneously

Additional Reporting and Analytics Capabilities

Reporting and Analytics provides advanced features that allow you to extend reporting, automate workflows, and integrate with external tools.

Reference your data
Build reports using the visual Question Builder interface
Write SQL queries
Send alerts to sponsors, monitors, or sites about key milestones or data conditions
Assign permissions (when RLS is enabled).
If your organization uses Row-Level Security, permissions and Permission Tags defined in Study Runner determine which forms and participants a user can see in Reporting and Analytics.
Without RLS, all Reporting and Analytics users can view all study data.
Access data via API
Automate data retrieval from Reporting and Analytics
- Retrieving results for existing Questions
- Running ad-hoc SQL queries
- Returning results in JSON, CSV, or Excel (XLSX) format
- Automating object creation, configuration, or other UI actions

Embedding Reporting and Analytics in Other Applications

You can embed a Dashboard or Question within another application using public or parameterized links.

Parameter Control Options:

Disabled: Default values are used; users cannot modify parameters
Editable: Users can adjust parameters in the embedded view
Locked: Parameters are predefined and signed by the embedding application