Release date: 21 July 2021

Added features and / or functionalities

Monitoring / Queries

Besides migrating all previous functionalities, information and features of the Monitoring module in a new interface that is more intuitive and easy to use, we’ve introduced a few new features to the Queries overview.

• A new ‘Action’ menu button for global actions has been added to Queries overview
• A new column has been added to allow users to select queries that are listed in the table
• Additional query information columns have been included in the table, that give the user moire insight into the details of these queries; The new columns are: “last updated by’, “Closed by’, ‘Query age’, ‘Time to resolve’ & ‘First remark’
• The row selection and the Record ID columns are now fixed to the right side of the table users to easily navigate to the right and left of the table without losing sight of the query row
• Users with export rights can now export the queries overview in bulk, either by exporting all available queries or only the the ones that the user has selected or filtered
• An table cell expand option has been added to specific table rows that (can) contain large content (eg. query remarks) to allow user to easily see the entire information when needed

Queuing

The queuing is the main change in this release underlying all the Castor EDC functionalities. Adding the queue mechanism to sending emails allows the more confident, fail-safe and streamlined emailing and communication with studies participants and Castor EDC users.

SAS export

The fully self-serviced SAS export feature is ready. The users are able to export study data in the SAS format of choice (SAS XPT or SAS 7BDAT). The new options are available in the records export dialogue. As the study data can have a significant size, the user requesting export will be notified upon export completion by email and provided with a direct link to our newly designed download area.

This feature currently is available upon customer request. To enable it please contact Castor support.

API updates

With this release, we are updating the Castor EDC API. To facilitate large reports datasets retrieval, Castor EDC API now allows filtering the response on the base of the “archived” property. Moreover, API users are able to search the specific record by different field values. This enhancment on the GET records endpoint is also working with encrypted data.

We have also allowed API access for the encrypted fields. This allows users using third party encryption providers like Trusted Reversible Encryption Service (TRES) to work with data on their premises.

Removed features and / or functionalities

No notable features or functionalities have been taken out of scope or removed from EDC in this product release with the exception of:

• Removing the ‘View in new tab’ option from the Queries data listing under the Monitoring tab.
  This occurred with the migration to a new, modern language on the user interface that allows users to continue making use of the previous functionality by right-clicking on the view icon.
• Removing the ‘Identifier’ field from ‘Add’ and ‘Edit’ modals of Study Phases, Study Steps & Survey Packages. This has become obsolete / deprecated with the introduction of new unique identifiers to all study elements (see section ‘Improved & extended features and / or functionalities‘).

Improved & extended features and / or functionalities

With this product update, we have introduced a series of improvements and enhancements to existing functionalities in EDC. A more detailed description of these, broken down by category, can be found below.

Monitoring overview

• The Monitoring tab has been entirely redesigned and all components have been given a new, more user-friendly look
• All previously available features have been migrated in a modern, more flexible and responsive interface
• All verifications, validations and queries that originate on steps or phases that are hidden for specific per user roles and / or hidden due to automation engine configurations are now hidden for those users in the Monitoring tables as well

Study Settings  

• The 'Monitoring' dropdown has been disabled (readOnly) for all studies that have at least one open query already created and have been set to ‘live’ to prevent inconsistencies between the study settings and the collected data; In all other circumstances, users can freely turn the Monitoring feature on and off

Form Sync

• The Form Sync process is now simplified by removing a time consuming step; The ‘Review missing unique identifiers’ view will be skipped from the user workflow, as there is no need any longer to input or validate identifiers
• The previously used properties for mapping study elements between two linked studies have been replaced with new unique identifiers
• The unique identifiers are unique across the entire study, automatically generated by the system and stored in the backend, removing the necessity for the the system user to make sure all required ones are in place on all study elements
• The new unique identifiers are available for the following elements: Option Groups, Surveys & Survey Steps, Reports & Report Steps, Options, Validations, Fields
• The variable name is not a mandatory field any longer due to the added unique identifiers in the backend

Form builder

• Changing the field type for fields in which data has been collected has been limited to only allow compatible field type changes, in order to prevent data loss

Records overview

• When the record ID generation is set to ‘Patient Study ID (free text), the user is prevented from adding the characters ‘[ARCHIVED-]’ in the field to prevent possible errors upon archiving records
• The Record ID column has been fixed to the left side of the table to allow users to navigate more easily to the right and left of the table without losing sight of the row (record) they are looking at
• The columns displayed by default have been reduced in number to allow easy access to the most relevant table columns on smaller screen sizes; This only applied to new studiers and system users have the possibility to change the visible columns from the cogwheel icon
• The list of displayed variables in the export dialog have been sorted alphanumerically based on the variable label

Data import

• When a study step is locked, warning message is displayed in the import preview for the user to inform that data will be imported in that step
• Information toast notifications have been set to automatically close, to allow users access to functionalities without interrupting the workflow

Audit trail

• The date & time of the user account registration has been added to all user-related Audit Trail events to allow all studies to which a user is active on to access and verify the account registration details
• The 'User created' event's location has been moved from the study specific Audit trail to the system Audit Trail

System defects fixes

A series of production defects have been fixed and included in this product update.

A summary of these is listed below:

• Toast messages did not appear on exporting using ‘Uploaded files (to zip-file)'
• Record ID did not get not updated in the audit trail for certain events after archiving a record 
• Clearing the lower / upper limit for a number field was not displayed as a change in Form Sync
• If was not possible to mark a phase or step as 'user missing' when calculation fields were present
• Audit trail event for Option group updated did not display all values for options
• Error was appearing upon filtering records due to user rights combinations
• It was possible to delete report steps with active report instances
• It was possible to delete an option group that was actively being used in a grid field
• It was possible to create two instituts with the same ‘test’ institute name
• The ‘Position’ field was not loading upon copying a field in the form structure
• Validations were triggered with 1 hours delay
• Long text file values were not completely visible in the printouts
• Dropdowns were displayed over Upload field in data entry view
• Clicking on an image field rendered a white square picture instead of enlarging the picture
• Copied step from a survey or a report to a study form was not visible in Structure tab until user created a new step
• Wrong information was shown on tooltip text when enforced 'exact match' was enabled for the study
• Page was refreshed redundantly after closing the modal dialog for ‘Manage Institutes’
• When a field was cleared / hidden because of the dependency parent, the subsequent validations did not get cleared
• It was not possible to open archived records from "Progress by phases & Progress by step" views

2021.4.1 - 28 July 2021

• The upload fields can be used in calculations.
• Fixed a bug where dropdown options in grid fields were not working correctly when using form sync.
• Fixed a bug where the user would see a waiting message when navigating too quickly to the reports overview in data entry.

2021.4.2 - 30 July 2021

• Randomization date is now available as a variable for calculations.

2021.4.3 - 3rd August  2021

• Fixed a bug where a user was not able to delete an institute and create another one using the same name.

2021.4.4 - 12 August 2021

• Fixed a bug where users were getting error 500 when using FormSync to create a linked study.
  NOTE: This was found to be caused by the size of the study’s XML structure and could have been reproduced on simple structure import as well. The fix implemented solves both situations
• Fixed a bug that affected automations when they point to the same field and executing the same action
  IMPORTANT NOTE: This defect has been in our system for a while, causing in some remote instances problems and ambiguous outcomes, due to a non-deterministic order of executing multiple automations pointing at the same field.
  Although the incidence of this defective flow on existing studies is minimal, there is a possibility that existing automations could now render unexpected results. If that is the case, please recheck the AE automations where 1 (one) field is used to trigger multiple ‘Show’ & ‘Hide’ automations.
  One example and likely scenario would be: Hide / Show multiple phases based on the Gender value(s). With this fix, the system will always firstly perform all ‘Hide’ operations, and only at the end execute any ‘Show’ operations. By having a defined order, a reliable & predictable outcome of all automations can be ensured every time.
• Extended endpoint to allow creating new Institutes via API

2021.4.5 - 10 September 2021

• An API user can now download EDC Audit Trail entries.
• Fixed a Matching Error that caused FormSync to not be able to merge changes.
• Fixed a bug where there were timeouts when exporting large study datasets.
• It is now possible to create up to 35 randomization groups instead of 9
• It is now possible to export surveys and reports when special characters are a part of the name.
• Fixed a bug where users without View Surveys rights were still able to see the Intro text.
• Fixed a defect that would give users with a certain role an incorrect set of rights.
• It is now possible to create field dependencies across steps in reports.

2021.4.6 - 6 October 2021

• Replaced 'General Terms & Conditions' with 'Master Service Agreement' in several places in EDC.
• Fixed a bug where survey creation automation were not working when creating the record via the API.
• Fixed a bug in form sync where the changes could not be merged after copying a survey structure.
• Added the page number in the response of the /study/{study_id}/record-progress/steps API endpoint.
• Security fix for structure imports.

EDC_2021.4_Release_Certificate.pdf