Release dates:
EU server: June 14, 6 pm CEST / 12 pm EDT
US server: June 15, 10 am CEST / 4 am EDT

New features

Introducing LAR signature capabilities

To better align with user needs, we’ve built the option to include LAR (Legally Authorized Representative) signatures in your eConsent process.

This includes a LAR ICF builder component that, when added, will consist of: 

• Configurable signature header

• Configurable signature statement (optional field)

• Signature fields: Full name, Date, Signature

This LAR signature component will still be editable and removable as long as the ICF template is a draft. The implications in the ICF builder will be that the Subject signature component is marked as 'optional'. Also, you can include a custom radio button field to collect the relationship of the LAR signer to the subject. In addition to this, LAR agreements can be added, edited and removed, and they can be set as optional or required.

All the LAR specific components of the ICF template are visible in both the HTML as the PDF version of the ICF template.

Along with the changes in the ICF builder, LAR has some other implications throughout eConsent. 

If the LAR signature component is enabled in the ICF template, users will be able to activate it during or after creating a subject record.  

An activated LAR signature component will also be reflected in the general subjects overview, showing in the “invite status”, “invited on” and “consent status” columns. The subject card will also show the LAR inclusion in the “Consent information (most recent)” section, and the button there echoes these changes.

As per sending invitations to sign an ICF, you can configure reminders to the LAR signer, just as with regular subject invitation reminders. The email notifications text is adapted to their LAR status. 

When adding a second ICF to a subject record that has an activated LAR signer, the LAR signature component on the new linked ICF will get automatically activated.

And in the case there is a linked Castor EDC study, if there is a LAR signer linked to a subject record, eConsent will share the email address of the LAR signer with the linked Castor EDC study.

How will this look from a LAR’s perspective?

An invited LAR signer will be able to login and interact with the subject facing side of the application.

In case the study requires them to fill in personal information of the subject, the LAR user will be  prompted to fill it in.

The fields 'Relationship to' and 'I am consenting on behalf of' on the ICF will auto-fill the name of the subject.

They will also be able to accept the LAR agreements on the ICF. The required LAR agreements must be ticked before the LAR can sign.

The LAR signer will be able to sign on the ICF. All the signing workflows are supported: asynchronous signing, singing during a video call, and the in-person signing flow.

What are the implications for the audit trail?

"Legally authorized representative" has been added as user type to the Audit trail events.

We’ve included a set of audit trail events related to LAR: ‘LAR invited to sign ICF’, ‘LAR accepted invitation’,  ‘LAR denied invitation’ and ’LAR reminded to sign ICF’.

Other enhancements

• From now on, study team members can be removed from a study. This will revoke their permissions and the user won’t be able to access the study. It will also trigger an audit trail event.

• We’ve improved the dialog to confirm the signers’ identity for the in-person signing flow: the text is adjusted and the user will need to actively tick a checkbox.

• The study title and study status have been added to the eConsent header bar, so now it can be seen at all times.

• ICF templates no longer display the pre-populated day of today, it will only auto-fill during the signing process.

• New ICFs can be assigned to the subject via the “Consent forms (most recent)” card in the subject profile.

• The fields in the “Personal details” card within a subject profile are no longer required to be filled in.

• The confirmation messages to send and resend an ICF invite to the subject or their LAR are now consistent throughout the system.

• When updating a signature header in the ICF builder now it’s directly reflected in the header of the card.

• We’ve replaced the audit trail event "Subject invited to eConsent" with "Subject invited to sign ICF". Also, the event "Subject reminded to sign ICF" will always be created when a reminder is sent.

• The audit trail has gone through some technical improvements.

• From now on, the action to send an ICF invitation from the subjects overview is only possible if there is an ICF linked to the subject.

System defects fixes

Here’s a list of the most relevant fixes included in this release:

• The audit trail event "Subject invited to sign ICF" was incorrectly triggered during subject record creation while not sending an ICF invite.

• It was possible to create duplicated screening IDs and subject IDs within the same study.

• Fixed a display issue when having more than 30 ICF templates in a study.

• The Spanish, German and Dutch translations, in subject facing screens of the application, were missing from some toast messages.

• For a specific scenario, the ICF was not getting unlocked after kicking off the in-person signing flow.

• The link to eConsent in the 'ICF signed' email notification to the subject was not always leading to the correct SSO login page.

• Fixed an issue for SSO users where the study invite was sent again when updating the role of the user.

• Some kebab menus weren't responding when using the vertical scroll.

• The name of the ICF template was editable after being Published, and it isn’t supposed to, so we’ve corrected that behavior.

• The Screening ID wasn't displaying the archived prefix.

• Now it’s no longer possible to remove all sites and all countries from a published ICF template.

• The study name was not showing in the information dialog when hitting the “i”icon in the general studies overview.

• Fixed the issue where the 'Loading...' mask in the Screening ID cell of the general Subjects overview wasn't displaying for studies that have a connection to Castor EDC.

• Fixed an issue where the record in a connected Castor EDC study was not getting created for a specific use case with a second study team member signature.

• Fixed various design/styling issues and inconsistencies, in:

  • the Consent forms overview

  • the study information dialog from the general studies overview

  • the "Invite user" dialog

  • the red validation messages in the "Add site" dialog

  • a validation message on the ICF template settings page.

Maintenance release 2022.2.1.0

Release date EU and US server: June 22, 12 pm CEST / 6 am EDT

Enhancements

The following enhancements related to the reporting capabilities are implemented:

• A third export report is now available; subject personal details.
• The email address of the subject is added to the Informed consent information report.

These reports are available upon request and will be added soon to the application itself.

System defect fixes

• Fixed an issue where changes in the user permissions were not getting updated correctly.
• Fixed an issue where a wrong English label was showing for a required LAR agreement (checkbox field) on the ICF template.