Starting with Medrio EDC Release 39.2, our goal is to simplify your validation process for new releases. New releases will now be categorized as either a major release or a minor release. A major release can introduce a change to existing functionality that may have a direct impact on an active study, depending on which capabilities you are currently using. A minor release is one that does not introduce changes that are immediately effective in the data capture, cleaning, or storage for an active study. The major/minor release approach enables your new studies to take advantage of new capabilities sooner. You are given the opportunity to enable a new capability for an existing study if that capability is important to you prior to study completion.
Minor Release
A minor release is one that does not introduce changes that are immediately effective in the data capture, cleaning, or storage for an active study.
A minor release is made available in the Validation Environment at the same time it is made available in the Production Environment.
A minor release contains any or all of the following:
- New features deployed in a disabled state with On/Off switches.
- Minor User Interface changes unrelated to feature functionality.
- For example: color changes, icon changes, label text
- Relocation of existing command, button, and/or link to a new location within the same page or menu
- Changes related to viewing data and that do not impact study configuration, data collection, or data cleaning.
- New or removed workflow steps do not change the outcome of the configuration / settings created by the steps.
- New options added to existing menus or multiple existing menus on a page consolidated.
- Enhancements to report or listing view options provided that new options do not impact saved report / listing settings.
- Fixes for issues determined to be defects.
- Note: fixes may result in changes to saved reports, logics, and /or listings if the fix implements expected design as reported by the customer and is validated during customer issue resolution processes.
Major Release
Major releases will include new features that are automatically enabled in both the Validation Environment and the Production Environment. Features that are not automatically enabled may also be in a major release.
A major release is deployed to the Validation Environment at least 28 days prior to deploying to the Production Environment on the release date.
A major release contains any or all of the following:
- New features deployed in an enabled state with On/Off switches.
- Changes to existing feature functionality or behavior that impact data collection, cleansing and/or regulatory based data reporting that are automatically enabled or disabled upon release for active and or newly provisioned studies.
- User Interface changes that change feature behavior and/or implement non-cosmetic changes.
- Fixes for issues found to be system defects.
Preview / Validation Environment
Another change you will see with the major/minor release approach is related to what you have previously known as the Preview Environment. We will now refer to the environment used for you to validate new releases as the Validation Environment. With a major release, the Validation Environment will be updated 28-days prior to updating Production Environment. With a minor release, the Validation Environment and the system you are currently using for studies (i.e., Production Environment) will be updated at the same time.
The Validation Environment will be permanently available, with the exception of future planned or emergency downtime. The Validation Environment includes a snapshot copy of your current Active studies. Active studies are not impacted by any changes made to the Validation Environment data or configuration settings.
Email-based communications are enabled in the Validation Environment for only User Management at this time.
- Email functionality is enabled to support validation process that require the use of these functionalities.
- Medrio strongly recommends caution when entering test data into studies for which email triggers are enabled.
- For example, if test data is entered into a study for which custom queries trigger an email, test data meeting the query conditions will trigger emails to be sent to all email addresses listed in the query definition.
- All emails sent from the Validation Environment include “TEST ONLY” in the subject line and “THIS IS FOR TESTING ONLY” in the body of the email.
- In order to avoid any confusion, Medrio strongly recommends updating the recipients of custom queries configured to send emails to include only approved test users.
- Emails will be sent when new users are given access to the Validation Environment studies.
- Emails for the following features have been disabled at this time:
- BYO and Standard reports.
- ePRO
- Queries
The Validation Environment supports the same manner of access and specific URLs that Production supports.
To validate various ways users may currently access or have historically accessed the system, please reference the following list of URLs.
Medrio recommends that users performing feature or study testing log in to the Validation Environment using the “Login” URL listed immediately below.
X indicates a placeholder for the specific instance on which the study has been provisioned
* Indicates a placeholder for the customization specified either at time of study provisioning or via configuration customization.
Refresh schedule
Data will be refreshed:
- On the first Friday of the 2nd month of each quarter
- 4 weeks before any major release
On these occasions, we’ll be copying your study data from production into the Validation Environment. When we refresh your Validation Environment, we will use a snapshot of your production studies, including both configuration and data. That snapshot may be taken as recently as the day before the refresh, up to one week before the refresh. The Validation Environment’s banner displays the date and time of the snapshot.
This refresh will overwrite any changes made in the Validation Environment to all areas, including configuration, data entry & management, saved reports, and User Administration.
During the refresh, users will experience downtime from 10:00AM to 10:00PM Pacific. The downtime will only apply to the Validation Environment; Production will not be affected.
Enabling Minor Release New Feature Functionality
To enable the new feature functionality in your Validation Environment studies or in your Active studies, please submit a Change Form to Medrio’s Support team using THIS LINK to our eForm.