Sandbox Environment - Updating Active Studies and Surveys

Learn how the Sandbox Environment is used for seamless testing and deployment of updates in active studies and surveys.

TABLE OF CONTENTS

• 1. How to use the sandbox?
  • 1.1. Creating a sandbox environment
  • 1.2. Identifying the sandbox environment
  • 1.3. Modifying study settings in the sandbox
  • 1.4. Testing the updated study in the sandbox environment
  • 1.5. Reverting or discarding the sandbox changes
• 2. Publishing updates to the active Study
  • 2.1. Publishing the sandbox updates
• 3. Sandbox-specific management rights
• Video

In clinical research, ensuring study integrity while making necessary amendments is crucial. The Sandbox Environment provides a secure, controlled space for testing changes before applying them to a live study or survey. This feature allows project configurators to create a mirror environment of an active project, where they can test updates, enroll test subjects, and validate workflows - without impacting real data.

With the sandbox, users can:

• Safely test amendments before rolling them out.
• Ensure compliance and accuracy by preventing unintended changes.
• Conduct user acceptance testing (UAT) in a realistic setup.
• Easily apply approved changes to the active project when ready.

The sandbox remains synchronized with the active study or survey, ensuring an up-to-date testing environment. Once the changes are validated, users can either publish them directly to the active project or discard the sandbox if modifications are no longer needed. In the following sections, the sandbox environment is explained with a focus on the study module; however, the same principles apply to Climedo’s survey module.

1. How to use the sandbox?

1.1. Creating a sandbox environment

	Navigate to the General Step 1 of the Study Settings of an active study. Click "Create Sandbox" to generate a sandbox environment that mirrors the settings of the active study.  Please note that the initial creation of a sandbox may take up to a few minutes, depending on project complexity.
	Confirm the creation of the sandbox environment in the pop-up.

1.2. Identifying the sandbox environment

	A banner or visual indicator is shown on all screens to clearly distinguish the sandbox from the active study. This applies to all setting screens, as well as ePRO and self-registration screens for sandbox test subjects.
	Users can seamlessly switch between active and sandbox settings/views using the top navigation bar.

1.3. Modifying study settings in the sandbox

Project configurators can make updates over an undefined timeline and save changes incrementally.

This includes all settings, incl. 

• General settings
• Access - roles
• Forms - all options
• Workflow - all options
• Trigger Events - all options
• Translations

1.4. Testing the updated study in the sandbox environment

The sandbox environment allows users to thoroughly test study updates before applying them to the active study. This ensures that all changes function as intended and meet compliance and quality standards. Users can perform various User Acceptance Testing (UAT) actions, including:

• Enrolling test subjects to verify participant workflows.
• Validating implemented changes to confirm their correctness.
• Simulating workflow processes, such as data entry, monitoring activities, (S)AE actions, and exports.
• Etc.

⚠️ It is important to note that certain project modules and functionalities are deactivated in the sandbox. Features that are not amendment-related, such as documents & files, dashboards, or reports, remain locked to maintain a focused testing environment.

1.5. Reverting or discarding the sandbox changes

If the changes made in the sandbox are no longer needed, users have the option to discard the sandbox, effectively resetting the environment. Only project configurators with the appropriate permissions (Publish or Create management rights – see section 3. below) can perform this action.

Key Considerations:

• Discarding the sandbox does not impact the live study. The active study remains unchanged.
• Once discarded, all changes made and saved in the sandbox are permanently lost. A confirmation popup will appear before finalizing this action.
• Important: Test subjects created within the sandbox are not discarded or deleted. They will remain available if the sandbox is re-created, ensuring continuity for future testing.

It is suggested to set all test subjects to the subject status dropped to prevent any future scheduled ePROs or eConsent reminders to be sent out. In the study overview in the sandbox tile, click on Open subject overview to create or view the test patients.

2. Publishing updates to the active study

2.1. Publishing the sandbox updates

Once all changes have been successfully tested, users can publish the changes. Only authorized users with the appropriate permissions can approve and apply these changes (see section 3 below).

Please note that the publishing action applies all updates made in the sandbox sequentially, meaning the amendments are processed step by step. As a result, the publishing process may take some time, depending on:

• The number of updates made in the sandbox.
• The complexity of the study setup.
• The number of enrolled subjects affected by the changes.

Once published, all modifications from the sandbox are applied to the active study, including updates to study settings, subjects, and user roles, triggering the amendment process.

Important Considerations:

• Changes may affect subjects, so it is strongly recommended to export study data before proceeding.
• All role and site affiliation updates made in the sandbox are for testing purposes only and will be reset upon publishing or discarding the sandbox. These modifications will not be transferred to the active study, ensuring that any changes made to collaborators' roles or site assignments remain isolated within the sandbox and do not affect the live study setup.
• If the publishing process fails due to rare issues, a clear error message will be displayed, providing guidance on the next steps.
• Upon successful publishing, the publisher will receive an email confirmation with all details, including a timestamp and any comments added during the publishing process.
• After publishing, users can re-create a sandbox at any time for future study updates.

3. Sandbox-specific management rights

There are two dedicated study management rights for managing the sandbox - "Create" and "Publish":

In order to access the sandbox environment from either the study card or the general setup, a user must have at least one of the following management view rights for the active study, which must be obtained before the sandbox is created: Collaborators, Roles, Sites, Input Forms & Fields, Study Settings, Randomization, or eConsent. Users who do not hold any of these rights will not see the sandbox access option. Once inside the sandbox, users can only view, update, or perform actions based on their assigned management rights, which apply uniformly across active studies/surveys and the sandbox environment.

View a detailed overview of the all management rights here.

Video

Take a look at our video tutorial on how to use the sandbox.