Release dates: 

EU server: March 7, 6 PM CET

US server: March 8, 10 AM CET

Added features/functionalities

Single Sign-On support

 We are extending our user management capabilities with the support of Single Sign-On (SSO), possibility to integrate external Identity Providers (IdPs) via OpenID Connect (OIDC). In this release we commence pilot integrations with our partners. This allows users to login to eConsent and sign consent forms using the authentication credentials from an external (non-Castor) identity provider. Further scaling is planned after the 2022.2 release.

Improved & extended features/functionalities

Multiple language support

• In addition to English, all eConsent emails that are sent to subjects are now available in Spanish, German and Dutch language. The language of the email is defined by the language that is assigned to the subject.
• In addition to the mentioned languages above, other languages for emails can now be configured upon request.
• An application language picker is now available in the user account settings, enabling subjects to change their application language when they have successfully logged in to eConsent.
• To ensure clarity, an information toast message “The eConsent platform is only available in English for study team members. Only subjects can view the eConsent platform in different languages.” will now be displayed when any other language than English was selected by a site user.
• The existing Spanish, German and Dutch content, in subject facing screens of the application, has been extended.

Enhancements around the ICFs

• The PDF output of your ICF now has the version displayed in the header and page numbering on the footer on each page.
• The default header for the subject signature component on the ICF labeled as “Subject signature” is now editable. This allows sponsors to use their own wording (for example “Participant signature”) and to support different ICF languages better.
• The date field(s) on the ICF are now getting displayed in the language that is assigned to the ICF.
• Some design improvements around adding and editing the subject checkboxes on ICF templates are implemented. The checkbox fields are also relabelled and are now called ‘Subject agreements’.

Other

• When opening the study as a subject, and the personal details “Name” is requested, the user name that the subject already saved in their account will be pre-populated.
• The ‘Eligibility’ field is now always editable for users with the permissions to do so. This was restricted before when the Eligibility was updated automatically based on the outcome of a linked Castor EDC survey.
• When adding a new subject, and there is a linked EDC survey that calculates the subject’s eligibility, the default setting to send out the invitation to the subject is now set to ‘No’. When selecting ‘Yes’, an information message will appear to inform the user that the general setup is to automatically send the invite only after the subject is found eligible.
• When there is a required second signature component on the ICF, the signature can be requested by sending an email notification.
• Locking and unlocking ICFs can now also be done via the ‘Consent information’ card in the profile page of the subject.
• The signature placeholder example in ICFs disappears automatically when hover over.
• The ‘Add new subject’ modal is replaced by a new screen.
• The design of the archived subject records in the general Subjects overview is improved.

Fixes

A number of previously reported issues have been resolved as part of this release. A summary of these is below:

• In a specific scenario an error was showing after an ICF was successfully signed by the investigator, this has been fixed.
• The study status was missing from a few audit trail events.
• The ICF version date has been restored to the general Subjects overview.
• The wrong styling of the region picker on the general Studies overview on Safari browsers is fixed.

Maintenance release 2022.1.1.0

Release date EU and US server: March 22

System defect fixes:

• Fixed an issue where the subject eligibility status was not always updating with the outcome of the EDC screening survey.
• Fixed an issue where multiple subject records with the same email address could be created.
• Fixed an issue where the audit trail event for study creation was displaying incorrect information.
• Fixed an issue where some audit trail details were showing incorrectly.

Maintenance release 2022.1.2.0

Release date EU and US server: May 11

Enhancement:

• Searching on Subject ID is supported.