Major Release 2022.4.0.0 -1st November 2022

Overview/Important Alerts

We will replace the former ‘Statistics’ tab with a new study dashboard in this product update. The dashboard contains aggregated data regarding the study progress, the randomization and queries. 
To fully benefit from this as a simple out of the box feature, we have also completed a migration that consolidates source data verification information between the database and the user interface. Some audit trail events might be visible in some affected studies following this release, introduced automatically by the system.

To learn more about what will be available please read this article along with the below summary of changes introduced in this product update.

New features and / or  enhancements

Users & site bulk import

This release introduces a set of improvements in users and site management. Using site configuration in study admin panel users can now bulk import sites into studies. We are launching this feature with CSV files import. To facilitate the import creation process, a sample file is available for download in the CDMS import dialog. File creation manual and good practices are available in this article.

From this release, CDMS users with “Manage Users” rights can bulk import into studies users from CSV files. To facilitate the import creation process, a sample file is available for download in the CDMS import dialog. We are launching this feature with a limit to 50 users in one import. You can import more users simply by dividing them in batches of 50 rows per file. 

We will be working towards lifting this limitation in upcoming releases. File creation manual, permissions coding manual, and good practices are available in this article.

Query management

We have expanded the filter option in the Queries listing to include the participant status. This will enable further drill down functionalities to be possible on the corresponding tab of the dashboard in the upcoming 2022.5 release.

Study Participants & surveys data listings

The Participant status filter in the overview of all study participants now includes the 'Not set' option, so users can easily retrieve all participants that have no status defined or chosen.

When creating a survey invitation, it was already possible to assign a survey package to a visit or repeating data instance. This information is now shown in both the participant-level surveys listing as in the global surveys listing (all participants).

 Reporting capabilities

Global repeating data listings 

We have redesigned the entire global listing for repeating data instances. All previous features and functionalities are now accessible in a new page, built in a consistent manner with other views such as global Queries, Validations, and the Audit trail.

A summary of functionalities that were added or moved can be found below. Additional options and functionalities are planned to be added in future product releases.

We have moved the Print, Delete, Archive, and Unarchive options in the newly designed view.

We have moved the SDV and Lock status icons in the newly designed view   

We have added a new  Progress column (which replaces the  ‘Status’ column). This column presents the data entry completion status of repeating data instances by using colors and wording.

We have extended the existing filter for archived status to allow for multi-select (e.g., archived and unarchived) on the global repeating data listing.

Study dashboard (former ‘Statistics’)

To help users to easily see what is the underlying data, we have added some direct links from the graphs, tables, and cards on the dashboard that redirect users to pre-filtered views in other places in the application. We will be expanding on these as we add more information both on the dashboard as well as on the data listings.  

Upon clicking these, users will be automatically redirected to the global participants overview, where the listings will show filtered data, according to the starting point and selected filters on the dashboard. Specifically, the following are now available:

The circles indicating dates on the graph shown in the 'Study progress’ tab are clickable. Doing so will automatically redirect users to the global participants overview, where the listings will show filtered data, according to the starting point and selected filters on the dashboard.

The 'Visit completion' table is clickable. Doing so will automatically redirect users to the global participants overview, where the listings will show filtered data, according to the starting point and selected filters on the dashboard.

The visible numbers in the ‘Participant status’ table shown are clickable. Doing so will automatically redirect users to the global participants overview, where the listings will show filtered data, according to the starting point and selected filters on the dashboard.

Additionally, we have also included the following:

For instances where the study is not live and the user does not have ‘Manage Participants’ rights, none of the elements on the dashboard's Study progress tab are clickable.

We have updated the labels on the dashboard displaying the cumulative number of all shown data from 'All sites' to 'Total' to better indicate that the information pertains to the selected sites in the filters and not necessarily all sites available in a study.

  To learn more about what will be available please read this article.

Structure/forms, export

You can now configure the button label displayed on top of a Repeated Measures field, that will create a new Repeated Measure form when clicked. This allows changing the default 'Add measurement' to a more applicable text for the given study context.

We have improved the performance of user role checks (checks that hide certain parts of the eCRF for certain users) throughout the system. Our next release contains more of these performance improvements.

Audit trail

New improvements to the Audit trail have been introduced. To facilitate search and display of relevant entries, now it’s possible to multi-select in “Event type” and “Triggered by” drop-downs.   

User Interface & User Access to system 

We improved the looks of the login page by updating the Castor logo and textual content.

We have increased the duration of displaying toast messages to 6 seconds to ensure that users have enough time to read error or warning messages.

We have implemented a first version of persistent filters. The user selection will not be cleared when navigating away to another page. These will be persistent for the user, per each study, during a continuous session.

System defects fixes

Participants / Randomization

We have fixed a defect that blocked opening participants in data entry after having removed a study user.

We have fixed a defect where date range filters in the participants overview did not include the 'end' date. The selected date is now included in the returned results.

We have fixed an issue regarding resetting the randomization when going live that blocked randomization on the same participant after the reset. 

Form Sync, Structure & Forms

We have addressed a defect on Form Sync, where an error was returned when the user was trying to apply changes to a repeating data instance configured with a source data verified grid field.

We have updated the terminology in the Field Finder to the new terminology used throughout our CDMS.

We fixed a defect where it was not possible to add special characters in survey names, such as "<". Survey names can now contain these characters.

Queries & Verifications

We have fixed a defect that prevented the queries count being hidden on the participant list if forms, visits, or repeating were data hidden by an automation.

We have fixed a defect that displayed the Pending SDV list in a loading state when a user has no View rights. The system now displays a message that there is no information to be shown.

We have fixed a console error displayed during the navigation through the monitoring menu. This had no user impact as the error was not surfaced in the UI.

We have fixed a defect leading to the SDV icon not been displayed when applied to Grid fields.

API, Export

We introduced a set of minor improvements in the SPSS exports and have addressed some label inconsistencies to other export formats.

We have improved our error handling in our API (/study/{study_id}/record endpoint)  and fixed an issue rendering a 500 error.

Data entry & Surveys

We have fixed a defect that blocked opening the participant in data entry after having removed a study user.

We have fixed a defect where line breaks in email notifications were not visible in sent emails.

We have resolved an issue where newly created repeating data instances associated with a visit were not being displayed within the visit navigation panel for clinicians.

We have resolved an issue where the displayed ‘available’ list of surveys for addition to a survey package was not being updated when reopened.

We have resolved an issue whereby when a mobile survey package was exported from one study and imported to another, the configured reminder text was not being retained.

We have fixed a defect related to the ordering of surveys while creating a survey package.

Misc.

We have fixed a defect that rendered a 403 error when clicking on 'Rights overview'.

We have fixed an issue that blocked users from importing ODM files.

We've fixed a defect happening on very specific use case, where the navigation between data entry and repeating data instances was not working properly.

Known release limitations 

Some changes have been introduced to the code base in preparation for releasing more functionalities in upcoming product updates. These are not accessible to the end user in v2022.4.0.0 and will be further documented  in later release notes.

Verifications

• We have removed the option to sort on the ‘Dropped by’ column in the general Verifications tab due to multiple issues that rendered incorrect results.

User import

• We are launching this feature with a limit to 50 users in one import.

Castor Connect

• The PIN reset function available within activation management for Castor Connect enabled studies continues to be non-functional until the deployment of release 2022.4 of Castor Connect

Maintenance Release 2022.4.1.0 - Release date 17th November 2022

 New features and / or  enhancements

• We have introduced a set of backend technical improvements,  that will allow us to deliver a more solid integration between Castor CDMS and eConsent. 
• For web based surveys, we've updated the logic so that we prevent participants from navigating away before all values on a single page have been saved and whilst calculations fields are running, to avoid any data loss due to slow internet connection or increased loading times on larger, more complex forms with multiple calculations and/or dependencies.

System defects fixes

Surveys

• Users will now be explicitly prevented from saving edits to reminders for already used/sent survey packages, and warned with an appropriate message.
• We have resolved an issue where, when editing a survey package that has already been sent, users were prompted to re-enter a planned date
• We have resolved an issue where, when a user moved to the next survey form whilst a calculation field was still loading, it rendered subsequent calculations or dependencies in other pages wrongly.  

Data entry

We have resolved an issue where, if a user navigated from one web survey form to another whilst a calculation was loading, a default value and error was being generated. 

Monitoring 

We've fixed a defect where the option to  'Export all' was grayed out and therefore unavailable for use on the global Queries listing.

We have addressed another issue on exporting queries from the global listing. An error was thrown when the user attempted to export filtered queries, blocking the export functionality.

 Forms

We have fixed a defect in the Add/Edit Field modal where a newly added field would not appear at the bottom of the form.

We have fixed a defect in the Dependencies section in the Add/Edit Field modal where the current form was not selected by default.

We have fixed a defect in the Add/Edit Field modal where a newly created Option Group was not selected automatically.

Export

We have fixed a problem where users were able to export without a proper export rights set. In order to export participant data, both ‘View’ and ‘where applicable ‘View surveys’,a s well as ’Export' site rights are required. 

API

• We carry on with our rate-limiting introduction project. For detailed information, please refer to the API change log page.  

Minor release 2022.4.1.1  - Release date 18th November 2022

• We’ve fixed a script used to sent out survey package instances. This has failed post 2022.4.1 release and has caused - for some studies- errors & delays in sending out surveys as scheduled.

Minor release 2022.4.1.2  - Release date 22nd November 2022

• We've fixed an issue that was adding a maximum character validation in the calculation template on fields. This was removed to allow users to keep creating longer templates, as needed.
• We have updated the ‘Edit SPI’ modal to allow the updating of the assigned visit or report/repeating data of a survey package instance without requiring a change in the planned send date.
• We have updated the ‘Edit SPI’ modal to prevent changing the planned send date for a survey package instance that has already been sent.

Minor release 2022.4.1.3  - Planned release date 1st December 2022

• We have fixed a defect related to Grid fields, where editing the field grid configurations would set all field types to Text fields. The grid configuration modal will now show the proper field types.