Castor EDC 2022.1 Release Notes

Release date: 22 March 2022

Added features and/or  functionalities

Records

The Record Status has been added to existing Audit trail events related to records. This is logged & stored statically, to ensure an accurate view of all the relevant details of a specific record.

We've also included the status to existing endpoints, so that users can directly see and access the status via the public API. 

Validation status

We've introduced a new property to our validations, allowing users with Query rights, such as monitors, to assess and directly mark validations as reviewed or resolved. This allows for a better management of active validations, so that the next time they log in and resume checking validations, only the pending ones are shown by default. 

Once marked as ‘resolved’, the validation is neither shown in the Validations overview (unless the specific filter for it is being applied) nor within Data entry.

We have also included a new filtering option, to allow retrieving all validations, regardless of their status. 

Important note: the Exclusion validation type is not in scope: it’s not available, nor can it be changed. This is due to the current use of the Exclusion type, which automatically prevents further data entry.

Automatic Signature removal settings for new queries

Study admins can now configure whether they want to automatically remove a signature when queries are opened on a signed form, from the Settings tab.

Login from external identity providers

We are extending our user management capabilities with the support of Single Sign-On (SSO), and the possibility to integrate external Identity Providers (IdPs) via Security Assertion Markup Language (SAML). In this release we are piloting integrations with some of our partners. This will enable users to log in to the EDC with credentials managed by external IdPs and directly from enterprise portals. Further scaling is planned after the 2022.2 release. 

Updated, improved & extended features and / or functionalities 

Records

We updated the “Email address” label in the study settings to “Record’s email” to reflect which email is being captured. The same change applies when creating a new record via the UI or an import.

Data import: preview dialog

We've upgraded the details shown during the data import process to convey better warnings when the variable names in the import files are not found in the study, so that users have actionable information to help them finalize the import.

More flexibility defining the repeated measure field

When building a form, your team can now choose which variables are shown in the associated table for the repeated measure field in data entry. This way, users can have a better overview of the most relevant information, rather than always having the first 6 variables preselected.

Study-user API endpoint allows to set permissions on user invitation 

The endpoint has been extended with the possibility to set management and Institute permissions while creating a new user account. This change allows more comprehensive user management via API. 

New recordIDs generation strategy for large scale studies

For large studies that may involve multiple concurrent records creation, we introduce the possibility to generate UUIDs (Universally Unique Identifiers) for the record. This solution ensures data consistency.

To enable this feature for your study, please contact customer support. 

Updated query export files 

When exporting query files (CSV and Excel), the relevant information will be displayed as shown in Castor’s user interface, so users can correlate the information effortlessly.

The summary of changes is as follows:

• 'queries.csv' file was renamed to ’study_<StudyName>_queries.csv’

• New columns have been added: Institute; Location; Last updated by / User; First remark / comment; Query age; Time to resolve

• Some columns headers have been updated: Field Variable name / label; Creation date (DD-MM-YYYY); Created by / User; Last status; Last remark / comment

• Some  deprecated columns were removed, having been replaced with with new ones: Field ID; Institute ID

Query management

We've extended the existing query logic to the Automation Engine, so that the expected behavior is consistent with locked entities. The information text shown while creating or editing an automation reflects this change as well.

“Reason for change” dialog

For studies running with the GCP feature enabled, the trigger mechanism for modal dialog to input a reason for change (RFC) has been updated to limit and avoid unnecessary dialogs showing up. We have accomplished that by changing the default trigger to when the user changes the mouse focus away from the field for most field types. For radio buttons, checkboxes and all date & time fields, we have increased the time before auto-saving to accommodate lower paced keyboard inputs. 

Additionally, whenever an edit is proposed for a submitted survey package, users must provide a reason for change before amendments can be saved. 

General UI & UX

We've implemented a series of changes and upgrades to the user interface. Here’s a summary:

• The AlertCart component was replaced with the Matter Banner component

• The term 'Real' has been updated to 'Production' throughout EDC

• A new CastorBar component has been introduced, replacing the old left side navigation in EDC

• The Toast component was replaced with the Matter ToastMessage component

• Additional design updates have been conducted on the 2FA screen, as well as on the Sign Up pages, both direct & via invite account registration

• We have improved the navigation animation

• The Select component’s default behavior has been changed to allow multiple selection without automatic window closing

• The EDC Pagination component has been replaced with a new Matter Pagination component

• We’ve added a new date range component, removing the need to select a start and an end date from 2 distinct date inputs

• The colors of the data entry navigation bar have been updated to match the new color scheme

• We've changed the default behavior of the Login button to always be enabled. If/when either one or both of the mandatory input fields are missing or incorrect, errors are shown only after clicking on the Login button.

Other Improvements

Better tracking of your SDV progress

We’ve re-worked the SDV (Source Data Verification) calculation logic for the fields, step and phase levels. This will ensure that marking something as verified will have the same outcome across all views and reports.

• The Step SDV banner is shown when the user chooses any of the options to SDV a step and when all required fields in a step have been individually SDV’ed

• The Step SDV icon is shown on the phase/step navigation bar when the user chooses any of the options to SDV a step or when all required fields in a step have been individually SDV’d 

• When the Step SDV banner is shown, the corresponding step is shown as SDV’d on the Step View of Records tab

Cascading SDV logic: 

• Adding SDV:

  • a step is considered SDV’ed when all the required fields have been individually marked as SDV’ed or if the step has been SDV’ed directly by the user

  • a Phase is considered SDV’ed when all its steps have been marked as SDV’ed 

  • a Report instance is considered SDV’ed when all its steps have been marked as SDV’ed 

• Dropping SDV: 

  • the Step SDV is removed when the SDV of any of the required fields within that step is removed 

  • the Phase SDV is removed when the SDV of any of its child Steps is removed 

  • the Report instance SDV is removed when the SDV of any of its child Steps is removed

Better phase signing notifications for users with blinded steps

We have updated the processes of signing a phase. Now if a user does not have view rights for all the steps, they are notified about the signature being applied only to steps for which viewing rights have been granted.

Internal enhancements to improve the Customer Success capabilities

We have updated the internal management features that will streamline Customer Success and study configuration processes.

Castor Connect improvements

We have added the ability to configure survey packages as training for the Castor Connect app. We have expanded the activation management function in the record view within EDC and finally implemented full server-based push notifications. More details will be available within the Castor Connect 2022.1 release notes when published.

Editing of survey packages submitted via Castor Connect

Users can now edit submitted survey package responses for surveys sent via Castor Connect, matching what is currently available for web surveys.

System defects fixes

Summary of fixed defects:

• Audit trail

  • Audit Trail API was crashing when SessionService had no active user

  • Phase-related event was being logged unnecessary

  • Filter by 'Record email address updated' was causing error in the audit trail 

  • Wrong ID was being shown in the Audit trail in the 'Record ID' column

  • Randomization fields in the Audit trail were visible to users with insufficient rights

• Data entry

  • Source report field was not being cleared from calculation field

• Import / Export

  • Importing non-date values in the date fields

  • Importing structure with metadata errors

  • Issue with Field level Audit trail (History) rendering information for imported report data

• Records

  • Issue with selecting checkboxes for records in Safari browser

  • Cursor was being shifted to the end of the value on Manage Record statuses view

• Structure

  • Structure menu options were sometimes duplicated

• User rights

  • Users rights overview and Users tab were sometimes not matching

  • Empty Survey and Randomization tabs were being displayed for users with insufficient rights

• API

  • 500 error in /study/{study_id}/audit-trail endpoint

• Other

  • Database-managed Feature Flags were causing performance issues

Release 2022.1.0.3 - 23 March 2022

• Fix for performance issue found on the data entry views for complex studies with many verifications
• Patch to optimize the memory usage required for Query Export
• Patch to increase the speed of the process involved to open any given study in EDC

Release 2022.1.0.4 -29 March 2022

• Fixed urgent query export issue
• Fixed defect regarding the visibility of premium feature Study Health Dashboard
• Reverted blanket application of  mandatory ‘Reason for change’ for editing all survey packages in-platform (reverted to pre-2022.1 behavior)
• Fixed issue regarding error showing up upon deleting field(s) from the structure
• Fixed error showing up upon applying changes using form sync for larger studies