Major release 2024.1.0.0 - Release date March 19th

New features and / or  enhancements

Verifications & Dashboard 

General specifications and edge cases

• A new ‘Verifications’ tab is available on the Dashboard page to all studies that have started using ‘SDV plans’ for their specific monitoring activities. 
  
• Within the dashboard, the study user can have dynamic control over how data is to be presented or organized (vertical vs horizontal, single-site or multi-center, stacked or grouped).
• Key  relevant metrics have been designed to  provide studies with a real time, live visual representation of SDV data further analysis. Before this point, Castor CDMS did not have capabilities to preset aggregated SDV data on different levels (form, visit, participant).

An overview of all events that update the SDV data on the dashboard can be reviewed below. We do recommend reloading the dashboard before  you start using it as an entry point to drill down to other listings, to make sure no temporary discrepancies get in the way of your tasks.

• The widgets will automatically filter out data of all elements that are blinded for  the user role(s) the logged in user has. This will allow the user to have an accurate picture of the information according to their own permissions and remove any discrepancies to any related verifications data listing that is now or will be available to drill down to.
• In 2024.1.0.0 we are enabling some drill-down capabilities. On the global Pending SDV page, a new filter has been made available, allowing the end user to multi-select defined participants statuses.
• The ‘pending’ SDV information displayed at field level can be clicked on, automatically redirecting the user over to the global ‘Pending SDV’ list.  
• This table will be pre-filtered to match the starting point on the dashboard metrics. More so, the ‘Pending SDV’ list now displays a new column, showcasing the number of outstanding queries for the fields that are pending source data verification.
  
• The dashboard widgets released in 2024.1.0.0 are dedicated to source data verifications and cover the following possible statuses for SDV at field, and by extension ar form, visit, repeating data or participant level:
  • Not ready =requiring SDV as per defined SDV plan, available* in the CRF, that does not have data collected and is not verified
  • Pending = requiring SDV as per defined SDV plan, available* in the CRF, , that has data collected and is not verified
  • Completed = requiring SDV as per defined SDV plan available* in the CRF, that has data collected and is verified
  • Missing data = requiring SDV as per defined SDV plan available* in the CRF, that does not have data collected and is verified

* not hidden by dependencies or automations

Overview of widgets

• With this product update, we’re going to introduce a total of 10 new dashboard widgets that are dedicated to source data verification, accessible to all studies using the ‘SDV plans’ feature that was released mid 2023. Below is the summary and high level description of these
  • Five tiles with information on ‘Completed’ (fields & participants),  ‘Pending’  (fields, forms & visits)
    
  • Two bar charts: a comparison of ‘Pending’ vs ‘Completed’  (fields & participants)
    
  • Two heat maps: one dedicated to SDV completion progress on visits, one for SDV completion progress on repeating data
    
  • One table with SDV status overview: clear distinction of all possible states that fields requiring SDV can be found in are presented in a summarized way
    

Special cases

• For studies or sites that do not have any SDV plan in place, the widgets will display an informative text, as no aggregated data can  be shown if no SDV plan is used.
• For studies or sites that deliberately utilize empty SDV plans to represent the complete lack of SDV requirements, the absolute values will display zero.
• In the case where the selected site(s)in the dashboard's filter have no SDV plan configured, then the tile widgets  on top will display ‘N/A’, as the total number of verifiable elements will always be zero.
  

Overview of study specific events  that trigger automatic updates of all data on the Verifications tab in the Dashboard

Due to various events that can take place at any time in the system, triggered by any number of users, we recommend reloading the dashboard regularly, to allow the system to query all underlying events and generate accurate, refreshed data across all widgets.

• SDV plans events: In some cases, it is necessary for studies to update their SDV plan(s). If the assignment of site to existing plans is edited or if the actual content of an SDV plan is changed to either include or exclude data points, the changes made are immediately picked up by the dashboard, right after the SDV plan is successfully published.
• Verification events: As soon as a logged in study user manually verifies or removes the SDV status from any visit or repeating data field included in an SDV plan, the dashboard will react automatically and update all relevant and affected widgets.
• Participant events: Every time participants are created, archived and unarchived, deleted or incur a change such as updating the site they belong to, an immediate reflection of those actions is added to the new Verifications dashboard. The absolute values as well as all the relative ones are recalculated, so the displayed values are always up to date.
• Repeating data instance(s) specific events: All source data verifications events related directly to repeating data instances have been covered and included in the dashboard. 
  • For sites that have repeating data fields selected in their assigned SDV plan, every time a new instance is created, archived/ unarchived or deleted, the corresponding widgets will project the updated situation. 
  • For example, for the selected site I see one single completed participant on the dashboard. I then proceed to create a new repeating data instance under the same participant. 
  • If that repeating data requires source data verification, but I have not yet begun to collect data, the 'SDV progress (participants)' bar chart will no longer show the participants as completed.
• Form Availability events: The dashboard widget reports are automatically recomputed once the availability of the participant's CRF is updated following automation engine events that show or hide forms and visits. 
  • The 'Clear inapplicable children' study setting is taken into account.
  • If enabled, it clears the value and removes the SDV status of data points automatically as soon as fields become hidden. When the condition is no longer met and the data points become available again, the data point’s SDV status will always be empty and not verified. 
  • If disabled, the value and the SDV status of data points remain stored in the database upon hiding the fields. When the condition is no longer met and the data points become available again, the SDV status and collected will be reflected in the dashboard. 
• Data Change events: As soon as a logged in study modifies the data collection of fields that are requiring SDV (in accordance to the defined SDV plan) via the interface, the API of using import files, the dashboard will react automatically and update all relevant and affected widgets.  
  • For example if a participant has 10 fields with data collected and verified, shown in the dashboard under the 'completed' data sets and user clears the field value on one of these fields, then in the dashboard widgets I can see the total number for 'completed' will have decreased with one unit.
• Structure import event: For studies that use the structure import feature to adjust their study design, the system will automatically pick up on the changes occurred and update the Verification dashboard metrics accordingly, to reflect SDV progress as per the defined SDV plan(s).
• Field dependency events: Field dependency events are immediately detected and projected onto the widgets. Depending on the study settings defined for a given study (see "Clear inapplicable children"),  if the field's availability changes after amending data collected in a way that the dependency condition is no longer met, the previously stored value and SDV status are kept or cleared. 
  • As long as dependent fields are not available, these are excluded from the aggregated data presented on the dashboard
• Form Sync events: Once a mid study update has been completed successfully using Form Sync, the dashboard's widgets for SDV will start to asynchronously update in order to reflect the SDV status across all of the study's participants and sites, as per the defined SDV plans active for the study's sites

As this process contains multiple single events that are applied to all participants, updating the SDV status  fully can take a few minutes, so we suggest refreshing the dashboard's view bearing the complexity of the applied changes in mind.

• (Direct) Structure change events: Direct study structure changes that are done without the use of Form Sync, such as adding, removing or updating visits, repeating data or any of the fields of these elements are being automatically reflected onto the dashboard metrics for source data verification.

Other relevant information 

• The underlying formula used for percentile values is using the current or selected data set, divided by the sum of all available data sets. 
• For example, SDV completed (participants) = Number of participants with all required  source data verifications completed / Total number of participants. In this formula, archived, deleted or hidden elements are excluded.
• In the heat map widgets for visit and repeating data SDV progress, each cell will display: 
  • How many instances of a specific visit do I have as completed divided by how many instances of  the same visit do I have available 
  • How many instances of a specific repeating data do I have as completed  divided by how many instances of  the same repeating data do I have available
  • Moreover, if the selected site(s) or all study sites have an empty SDV plan assigned, the widgets will show 100% for completion. For visits or repeating data that have no fields in any SDV plan, the corresponding heat-map cells will as well show 100%

User Management

• We've introduced an "Any new site" option while inviting users to a study or updating user roles. Now, study admins can assign roles that automatically apply to all future sites, eliminating the need to update permissions every time a site is added.
• We've added an option to invite multiple users at once by entering their emails separated by commas in the Add User modal. A maximum of 15 users can be invited at a time in the modal. The Import Users feature can be used to import more users.

• Support for the new "Any new site" option is added to the API. 
• A new default_role_assignment parameter is added. More information about this parameter can be found in our API documentation.
• Support for the new "Any new site" option is added to the Import Users feature. A new 'Any new site' column is added, by adding a '1' into this column, the specific role will be set as default for any new site.

Export

• We've enhanced our participant data export functionality. CSV, Excel, SPSS, and CDISC ODM participant data exports will process asynchronously in the background, significantly benefiting larger data exports. 
• You'll receive an email notification when your export file is ready to download. Exports can be downloaded from the Export page that you can access either via the link in the email or via the left navigation menu. 
• In case an export has failed, an email notification will be sent as well, with a link to restart the export.
• We have enhanced our export logging. Expired export logs are now kept, and expired exports are no longer visible on the Export page. 
• We have added a boolean (‘isArchived’) to the data export endpoint (/export/data), which allows you to distinguish if data is from an archived survey, repeating data, or participant

Forms

• Now, when adding or editing fields in new studies, specifying a variable name for each field is mandatory. This change guarantees that the structure of your data export is transparent right from the study's setup phase, ensuring seamless and consistent data management throughout your study.
• To help you define a variable name, we have added the option to the Add/Edit Field Modal to generate a variable name based on the Field Label. 
• We have updated the Form Structure importer to reflect the variable name enforcement. When a Form Structure XML or ODM XML file is imported with Fields without variable names, the variable names are now automatically generated.
• We have added a help text for the variable field when the SAS export is enabled. The message reads that variable names exceeding 32 characters will be truncated in SAS.
• We have updated the way variable names are generated when fields, forms, visits, repeating data, and surveys are copied. New variable names will now be limited to a maximum of 64 characters.
• We have added a Preview button to the Add/Edit Field modal for new slider fields, which allows you to preview and test the slider configuration.

Survey Compliance Listing

In our last release, we added an additional survey listing the ‘survey compliance listing’ for a limited subset of studies. We are now extending that to all studies. This listing includes all the features of our pre-existing listing with a focus on displaying a ‘compliance percentage’ - I.E. the number of survey package invitations completed (all required fields answered) of those available to a participant, expressed as a percentage.

 In addition to the features delivered in the last release, we have added:

• Users will now have both the pre-existing survey listing and the new survey compliance listing by default, with options to select just one as a default from within the study settings page
• The compliance filters have been updated to allow for multi-select of sites, survey packages and statuses to enhance usability
• Clinicians who have both export permissions and access to the survey compliance listing will be able to request an export of their filtered compliance data. This will become available as a downloadable file in the 'Exports' section of the CDMS. 
• Export files will only be visible/accessible to the user who initiated the request

Extended televisit pilot

We have extended the televisit pilot to allow for additional clinicians and an updated user interface.

• CDMS televisits will now allow two clinicians to join a participant televisit simultaneously. 
• CDMS users with the appropriate permissions can define and amend 'attendees' for televisits to ensure the appropriate clinician attends the televisit and receives notifications.
  • The televisit waiting room and scheduling email have been updated to include references to any assigned attendees
  • The planner design has been updated to be more consistent with other participant-level pages/views
  • The next scheduled televisit will be displayed within the participant summary block when televisits are turned on for a study
  • User-specific audit trail events have been added for the joining and leaving of televisit sessions
  • When the attendees of a televisit are updated, the user performing the update will have an opportunity to ‘resend’ any scheduling emails to the new attendee(s)
  • The televisit controls (mic, video, full screen) will now only appear when the video viewer is being hovered over
  • Users can now 'Drag' the video viewer around the screen instead of fixing it to a corner

Miscellaneous

• We have updated the study’s page header, making it a global consistent entity when navigating through various study pages. Once a study is opened, the header will display (where applicable), the following elements in this order: logo, study name, study "live" status, study version number. 
  Because we're incorporating the logo in the header itself, the preview of this in the "General" tab of the study's settings page has been removed.  
  • Please be reminded that the maximum file size allowed for the logo is 2MB. Additionally, in the data entry view, the participant's status dropdown has also been removed from the header. The status can easily be reviewed and edited from the participant card found on the pages left upper side.
• The ‘Pending SDV’ listing with sorting and pagination was included in the Monitoring section that is available at participant level. All existing studies will be able to benefit from this starting with v2024.1.0.0.
• The option to display 'Modern web surveys' has been moved to study properties, and is only available if surveys are available at all on a study.
• For survey packages configured for Castor Connect, we have extended the configuration capabilities within the Automation engine. An additional 'Time' input has been added to the modal presented while configuring automated surveys scheduling within the Automation engine. This will allow for a more precise and better control of the desired outcome. 
  • By default, this new 'Time' input is empty, meaning that automations will fire based on the trigger event's  date and time, plus the exact number of configured days.
    If the input is not empty, the automation will fire at the configured time (in the server's timezone). To better exemplify, see the possible outcomes below.
  • Example: I want my automation to fire one day (+1 day)  after the configured event is triggered in CDMS, at 09:00 AM.  The following possible scenarios will apply:
    When the configured event is triggered on 01-JAN-2024 at 9:00 AM, then the automation will be fired on 02-JAN-2024 at 9AM (after exactly 24 hours)
    When the configured event is triggered on 01-JAN-2024 at 8:00 AM, then the automation will be fired on 02-JAN-2024 at 9AM (after exactly 25 hours)
    When the configured event is triggered on 01-JAN-2024 10:00 AM, then the automation will be fired on 02-JAN-2024 at 9AM (after exactly 23 hours)
  • Please note that this modal dialog can be resized by dragging its corners, so that all inputs are easily visible on smaller sized screens.
• A “Site Created” event will now be added to the Audit Trail upon the creation of a study.  

System defects fixes

Verifications & dashboard

• We have addressed an issue occurring on studies that do not use the  'Clear inapplicable child fields' setting. In these cases, the SDV status of dependent fields was lost when the condition was no longer met, making the dependent child field available once more in the repeating data instance form.
• We have addressed another issue occurring on studies that do not use the  'Clear inapplicable child fields' setting. In these cases, the SDV status of fields within a form or visit hidden by the automation engine was lost when the condition was no longer met.
• We have addressed an issue occurring on studies that do not use the  'Clear inapplicable child fields' setting. In these cases, the SDV status of dependent fields was lost when the condition was no longer met, making the dependent child field available once more in the form.
• We've addressed an issue that presented the queries dashboard tab to studies that did not use or disabled the Monitoring feature.

Participants and Data entry

• We have fixed a defect that did not lock the participant when the action was being triggered together with applying the signature from the participants overview page.
• We have fixed an issue that prevented showing the name of the option within an Option Group when a checkbox field's history was opened by a study user. 
• We have resolved an issue where 'Centered' fields were not displaying consistently in the center when using modern web surveys in the mobile view
• We have resolved an issue where users using a combination of partial dates and dependencies were seeing dependent fields disappear and require a refresh when they triggered, un-triggered then re-triggered that dependency
• We have addressed an issue with legacy surveys where surveys configured to send users to another URL on completion were displaying a confusing message before user was redirected
• We have added a validation to fields to prevent the accepting of 'blank' or whitespace values (for example typing a space) as a valid value.
•  We have removed an unnecessary check for dollar signs in validation when deleting participants
•  We have resolved an issue where users working in timezones forward of the CDMS server they use were seeing the displayed ‘surveys sent’ time based on their user time when using ‘send now’
• We have resolved an issue where the in-CDMS clinician view/edit survey function was cramped after a recent UI update. The UI has been updated to make the elements more clearly visible.
• We have addressed an issue where  repeating data or surveys forms of excluded participants could be updated if they were opened, closed and opened repeatedly.

Export

• We have fixed a defect in the participant data export that previously resulted in the unintended export of all forms, including empty ones, when selecting a limited number of variables. Now, only the forms containing the selected variables are exported.
• We have fixed a defect where repeating data parent names were missing from survey export files.
• We have fixed an internal issue regarding processing blinding rules for archived studies. 
• We have fixed an issue regarding 'Export expired' events not being saved in the Audit Trail.

Miscellaneous

• We have addressed an issue that prevented users from leaving the 'Expire after' input empty while configuring survey packages designed for mobile use with Castor Connect.
• We have fixed a defect that resulted in email notifications for "Repeating Data Instance Completed" being sent every time a query  was set to ‘Closed’ status.
• A defect regarding the automation engine has been fixed. This issue had prevented automations configured to send survey invitations when an email was added to a participant from being sent if that email was created using the data import functionality.
• We have fixed an issue regarding the importing of users when the user being imported is a customer support representative.
• We have fixed an issue regarding the import of duplicate variable names when importing Form Structures. If a duplicate variable name is identified, the system will now generate a new variable name.
• The televisits access code screen will no longer retain previously entered codes in the users browser to reduce confusion/likelihood of user error 

Known release limitations 

• When a Participant Data export of encrypted data via ZorgTTP fails because invalid credentials were provided, the export fails but the status on the Export page remains 'In progress'. This issue will be addressed in a later release.

 Hotfix release 2024.1.0.1 - Release date March 20th

• We have fixed a defect related to the FHIR import process.
• We have fixed a defect where certain scheduled jobs could not complete after the upgrade to v2024.1.0.0.

 Hotfix release 2024.1.0.2 - Release date March 25th

• We have added a change to the SDV dashboard onboarding tool to improve the way we backfill the dashboard metrics for studies with archived participants and repeating data instances with more than one form, that are included in active SDV plans. 
   

 Hotfix release 2024.1.0.3 - Release date March 27th

• We have addressed an issue that resulted in failed exports for some of the Castor studies.
• We have improved the performance of the read models used for the Verifications reports 

Maintenance release 2024.1.1.0 - Release date April 12th

New features and / or  enhancements

• To avoid bias, we have introduced a new setting for the slider field, that allows the user to either show or hide the selection marker (draggable element) before a response is selected. When turned off, the marker will be hidden and when the setting is turned on the marker will be shown right away. By default this setting will be turned off. Any existing slider fields will remain unaffected by this change.
• It is now possible to add the Castor Connect activation QR code to survey package invitation emails using a dedicated tag: {CC-activation-QR}
• Similarly, we have added a QR code that can be scanned from within the PIN Reset email for Castor Connect when a participant has indicated they have forgotten their PIN
• We've included a series of technical improvement to reduce the load on and prevent saturation on the queuing mechanism.

System defects fixes

• We have fixed an issue where in some cases a survey wouldn't load because of extra characters in the survey URL. 
• It is now possible to mix OIDC SSO users and general users with a study that enforces 2FA.
• We have fixed a defect where SAS exports could not be downloaded.

 Hotfix release 2024.1.1.1 - Release date April 17th

• We have resolved an issue where a number of archived Castor Connect survey package invitations were triggering push notifications potentially confusing participants.

Maintenance release 2024.1.2.0 - Release date May 3rd

System defects fixes

• We have fixed a typo on PIN reset emails sent to clinicians.
• We have fixed an issue that led to inconsistencies of displayed data in the dashboard when existing dependencies were updated directly in the study's structure by changing the parent field.
• We have fixed a defect where, when exporting queries, the first remark appears in the last remark field and the last remark appears in the first remark field.

Maintenance release 2024.1.3.0 - Tentative release date May 27th

New features and / or  enhancements

• Improved the "slider" field type configuration to accommodate additional study design needs. This change will not impact any existing studies.

System defects fixes

• We have fixed a visual issue on the interface, that resulted in having the icons and the text on 'My studies' page misaligned.
• Fixed an issue where filtering on a specific site was not working correctly on the survey overview.