Major Release 2022.3.0.0 -Release date 18 August 2022

Overview/Important Alerts

With this CDMS release, we are changing a few key terms throughout the user interface in order to better align with those more commonly used in our industry. By using terms more familiar to our users in Castor’s CDMS, we aim to reduce the learning curve and improve the overall experience of our platform. You can read about these changes in more detail here.

New features and enhancements

Participant Monitoring listings 

We have redesigned the participant level Queries, Validations, Verifications listings, including sorting & pagination. The filters of these views have also been redesigned in an effort to modernize the look and feel of CDMS.

We have also expanded the filter criteria for Validations on the participant level screen to include the validation status, in the same way it is on the global listing.

 Study Monitoring listings

A separate tab listing the performed verifications is now available on the Verifications page. This new listing allows users to easily find the verifications that are relevant to them and brings a capability that was only available via the API to the User Interface. 

We have also introduced a new column to the global pending SDV listing. This column displays the field label and, when available, the field variable name. It is positioned first in the table and it is fixed, so that users can always see what field they are looking at when scrolling horizontally.

In-EDC Televisit with Participants

With this new version of the platform, a pilot televisits feature will be made available for a small number of users to gather feedback ahead of a full release. Clinicians can schedule and join televisits directly from within the CDMS participant view, with participants being offered a secure waiting room experience on invitation.

Once in a call, clinicians can navigate around the platform to discuss submitted assessment data or to check in on a participant’s progress during the call.

- For Clinicians

- When the new ‘Televisits’ feature is enabled for a study, and televisit permissions are assigned to their account - a new ‘Televisit planner’ tab will be made available for clinicians within the participant view.

- The televisit planner will allow them to schedule, reschedule, cancel and participate in video calls with participants directly - receiving associated confirmation and reminder notifications by email, with key actions captured in the study audit trail. 
 

- For Participants

- Participants will receive email notifications containing call information and a calendar object to add to their personal calendars whenever a televisit session is scheduled,  is coming up soon or has been canceled or rescheduled. A reschedule or cancellation can be submitted from within these emails.

- Participants attempting to join a televisit session will be asked to enter an access code (sent by email), and will be shown into a virtual waiting room that provides context for the call and allows them to set up their audio and video devices prior to joining the call.

Castor Connect

We have added a number of new configuration options to the platform that allow for greater flexibility when building Castor Connect enabled studies. The below listed features are included in the CDMS 2022.3 version, but are intended to accompany the next major release of Castor Connect in August. 

- When configuring a mobile survey package, within the scheduling tab a new ‘Mobile Survey Display’ configuration option has been added. Admins can now configure fields to be displayed one field per screen (current behavior), or have multiple fields per page. When enabled, questions/fields configured as part of an assessment will be displayed in the app according to their configured pages or steps. Users who want to retain the existing one field per page configuration can leave this setting as is.

- Mobile survey packages can now be configured as ‘Resumable’ - allowing participants to partially complete then return later to a survey package, as long as it has not expired or been completed.

- Mobile survey packages can also now be configured as ‘Repeatable’ - allowing for the completion of a survey package repeatedly until it expires. This could be useful for ad-hoc surveys like a participant’s food or bleed diary.

- To allow users to distinguish between optional and mandatory tasks in the app, mobile survey packages can also now be marked ‘as needed.’ These assessments will be listed in a separate list within the app UI.

- Mobile surveys can now be triggered by field and participant email updates within the automation engine the same way web surveys can. For example, a participant’s activation details and training survey could be sent automatically when enrolled rather than the clinician having to do it manually.

Standard reporting capabilities / Study dashboard

In this release, we will make a pilot dashboard feature available for a small number of users to gather feedback ahead of a full release. The dashboard includes graphs and tables on three tabs categorized by study progress, randomization and queries. 

 Study Progress Tab

- Upon opening the dashboard, users will land on the Study Progress tab, which includes information on participant record creation, participant statuses, and study progress. 

- The first graph on this tab is the participant record creation graph (the number of participant records created over time). The graph either shows the cumulative number of records created (when all of the available sites are selected) or the number per site.

- The participant visit completion table shows the percentage of participants that have completed a visit, split out per site. The information is presented  as a heatmap. The darker the blue, the higher the percentage.

- The visit status overview table shows the number of visits across all participants that have been completed or not yet completed, source-data verified, signed or locked. This is non-exclusive, so a visit can be in multiple statuses. 

Randomization Tab

- The Randomization tab contains a table and a graph, showing values for each randomization group on a per site basis.

Queries Tab

- The Queries tab provides an overview of the pending queries, the average time to close queries and the forms with the most queries within a study. 

General dashboard functionality

- It is possible to filter the dashboards by site and participant status. The filter is saved on a study and user level and will, therefore, still be in place when returning to the dashboard at a later time. 

- On top of the dashboard, users will see when the dashboard data was last updated and will have the opportunity to refresh it. 

- To ensure an easy feedback loop, a button was added to the dashboard screen enabling users to submit feedback.

- The dashboards will only show data to which the user has access to. An information banner regarding this has been placed on the bottom of the dashboard page.

Important note:
To ensure all data regarding SDV is shown correctly on the dashboard, we are running a large migration for the selected studies, in order to consolidate the cascading logic of verifications across the database and the user interface. We will be rolling out a minor product update to include the SDV status of visits as a separated column in the 'Visit status overview' table as soon as the migration reaches 100%. This may result in entries in the audit trail. 

Application Programming Interface (API), User Interface & User Access to the system

The password reset page has been redesigned to be consistent with other similar views of the login and sign up pages. We have updated the two factor authentication view to show possible errors grouped together.

We have improved the “create new study” page. Users will now be able to see required fields as well as the most relevant information about required field validation, making the entire page more efficient.

In Castor CDMS version 2021.6, we added the option to set a specific date format per institute (e.g., DD-MM-YYYY). In this release, we extended the API Institute endpoint to include this date format as well (available as ‘date_format’).

We updated the  Record Progress endpoint logic to match the completion status of each form in a study that is shown in CDMS’ User Interface. The API endpoint now takes non-required fields into account when determining the completion status. In addition, we added the percentage of completed fields per step (what is referred to as the `progress` field in the UI) to the response of this endpoint.  

Single Sign-On support 

We are extending our user management capabilities with the support of Single Sign-On (SSO). Our SAML-based implementation integrates with external Identity Providers (IdPs) to provide user authentication. For users in configured enterprise IdPs, existing user accounts can become SSO user accounts. Existing users will retain access to current studies when authenticating with their existing credentials. This feature is available per request only.

Study participants listing

We have introduced the option to keep the Participant creation modal dialog open in order to facilitate the creation of multiple participants via the UI. Additionally, we have included the participant's ID in the email dialog for better visualization of the participant before updating the associated email address.

Reordering options in an option group

We have added the functionality to reorder items in an option group. You are now able to reorder items while editing an option group by using drag and drop. 

System defects fixes

1. We have fixed our Audit Trail filters, so that you can also filter by users that are no longer part of the study.
2. We have fixed a defect concerning the display of field searchability options in the Form Builder when data was collected on an encrypted field.
3. We have improved the security of the internal configuration performed by our CS managers. 
4. We fixed a defect where in some cases the form builder would show study fields in the report or survey section.
5. We fixed a defect where the ordering of query remarks was different in the two available modal dialogs in data entry.
6. We have fixed a defect regarding text mis-alignment on the global participants data listing.
7. We have fixed a defect where a "Are you sure you want to continue?" popup is displayed even if the title for a not used option group was changed.
8. We have fixed some defects around the 2FA that permitted users to sometimes open a study, after the study has had Two Factor authentication enabled.
9. We have fixed a problem with importing where the importing field with option groups would create audit trail entries for the fields but not for the option groups.
10. We have improved the handling and logging of failed login attempts.
11. We have resolved an issue where no guidance text was offered for users with no configured surveys when they navigated to the surveys overview.
12. We have updated the options selected by default when creating a survey package using an in-form survey package button. They were erroneously changed as part of updating that modal, but have been restored to their previously expected default behavior.
13. We have resolved an issue where televisits scheduled for a now-deleted user were generating errors.
14. We have fixed a defect where the scroll bar would disappear after a form structure XML file was imported.
15. We have fixed a defect causing the markdown to not be properly rendered in the print preview.

Maintenance Release 2022.3.1.0 - Release date 31 August 2022

System defects fixes

We have addressed and fixed the following defects and issues:

• an accidental hiding of the global Repeating Data tab on the main navigation for live studies
• a low defect, with errors being shown on some specific studies with access to an extra, non-core feature enabled;
• a system flaw where Site related filters and statistics could not load due to a missing country configuration;

New features and / or  enhancements

For the beta feature ‘Study Dashboard’, we've introduced a new column for one of the available tables.

Additionally, we have slightly improved our Excel export, as well as the way we handle the field variables and labels in the queries exports.

When a form was being hidden as a result of an automation being triggered in the automation engine, an event named ‘Form hidden’ was logged in the Audit trail of the study. We have slightly updated this to be in line with all other similar events. The event is not bound to any specific user role.

Castor Connect
A remote PIN reset function has been added to the activation management modal on Castor Connect enabled studies. Once paired with release 2022.3 of the Castor Connect app, this will allow for full remote resets of the participant PIN for Castor Connect without the need for reactivation or reinstallation. Castor Connect 2022.3 is planned for release in September 2022.

 

Maintenance Release 2022.3.2.0 - 29th September 2022

New features and / or  enhancements

• We improved the presentation of user roles for grid fields in the Audit Trial
•  API usage has been restricted for accounts using SSO and Hybrid- SSO

Castor Connect enabled studies

• The activation emails and push notifications associated with a mobile survey package are now editable by study builders
• A remote PIN reset function has been added to the activation management modal for Castor Connect enabled studies
  • Remote PIN reset will only function for participants using a PIN, instead of native security
  • Remote PIN reset is paired with the upcoming 2022.4 Castor Connect release, and is non-functional until that release
  • Where a reset has been requested by a participant, an indicator will be added to both the participants overview page and the activation status indicator for; in addition, a notification email will be sent to clinician users with both the manage participants and send survey permissions at the participant’s site
  • An audit trail event will be added to the study audit trail on PIN creation and reset

System defects fixes

We have addressed and fixed the following defects and issues:

• We have fixed an issue where XML exports containing a Survey without forms could not be imported
• We have addressed an error that was occurring when trying to merge changes in linked studies with Castor Connect enabled survey packages. 
• We fixed a problem where it is not possible to archive repeating data for users without the Edit rights and with Archive rights. Now Edit rights are not mandatory
• An issue where the 'Add survey' button in forms was not retaining the configured visit. Now, when the button is configured to include a specific visit it will include it by default
  
   

Maintenance Release 2022.3.3.0 - 14th October 2022

System defects fixes

We have addressed and fixed the following defects and issues:

• We have implemented a security fix for survey packages.