Released: 14 December 2021

Added features/functionalities

Configurable signatures

The needed signature components on the consent forms can now be configured on a form level.

Only subject signature

Some documents only require a subject signature and no counter signature by a study team member. This use case is now supported by eConsent.

• The study team member signature component on the ICF template is now removable, which leads to only having a subject signature component included.
• Once a subject has signed the ICF that does not include a study team member signature component, the consent status of the form is set to ‘Consented’ as it is fully signed.

Second study team member signature/site signature

Some documents may require two study team member signatures.

• A second study team member signature component can be added to the ICF template. This second signature can be setup as:
  • Required - The second study team member signature component always needs to be signed before the ICF is set to completely signed (status ‘Consented’);
  • Optional - If it is unknown upfront whether a second study team member signature is needed for a specific form or subject, the second signature can be marked as optional. In that case, the second study team member signature component needs to be (de)activated by the first study team member that signs the ICF. If the signature component is deactivated, it can no longer be signed. If the signature component is activated, it has to be signed before the ICF is set to completely signed (‘Consented’).
• A new section called ‘Additional signature(s) details’ in the ‘Consent form (most recent)’ card on the profile page of the subject has been added. This section displays the consent status of the additional signature, the header name of the additional signature, and whether a notification has been sent
• When there is a required second signature component, or an activated optional second signature component, a signature can be requested by sending an email notification.
• Once a second signature component is activated by mistake, this component can be deactivated again via the action in the kebab menu of the ICF. This also works the other way around; a deactivated signature component can be activated again.
• The second study team member signature component can be signed by users with sign rights. The second signatory cannot be the same as the one who is required to sign on the first signature component.
• The headers of the study team member signatures are configurable per ICF template.
• Activating or deactivating the signature components is logged on the audit trail.

Subject personal details

Additional personal details of the subjects can now be collected. Data to be collected can now be configured on a per study level, and subjects will be prompted to fill in the data. Study team members can also add and edit this information.

• The requested subject personal details can be configured on a study level via a new tab page called ‘Personal details fields’ that has been added to the Study Settings menu. The following subject information can be collected: Name, Date of birth, Gender, Phone number, Address.
• When opening the study as a subject, and there are personal details requested, the subject is prompted to fill in and submit their data before continuing. Subjects can always review their submitted data via the ‘Study Profile’ tab.
• On the study team part of the application, the ‘Personal details’ card of the subject profile is extended. This card displays the information that is submitted by the subject. Study team members can edit information, if needed.
• Changes concerning the subject's personal details are logged in the audit trail.

Multiple language support

The subject facing screens of eConsent are now available in 3 additional languages besides English: Spanish (international), German (Germany) and Dutch (The Netherlands). More languages can be supported upon request.

• Subjects can choose the language on the application during login and sign up.
• The field labels for Full name, Date and Signature on the consent forms are getting translated in the selected consent form language.
• When inviting a subject to an ICF in one of the supported languages, the subject will see that language on the verification page.

Reporting capabilities

Two default export capabilities are now available; audit trail and signature statuses per consent form. The export reports are for now only available upon request and will be added soon to the application itself.

Improved & extended features/functionalities

Enhancements for subjects

• An email notification is sent to the subject once the ICF is fully signed. Subjects can view the signed ICF when following the link on the email.
• To improve the signing experience, the ‘Draw Signature’ placeholder text in an empty Signature field is replaced by an image of an example signature.
• A link to a video troubleshooting page is added in the information text of the ‘Scheduled video call’ component.

Enhancements on subject profile tab

• The field labels ‘Initial consent’ and ‘Invited on’ have now been relabeled to ‘Consent form signed on’ and ‘Consent form sent on’ to better reflect the data they contain.
• The field ‘Invite status’ is moved to the ‘Subject profile’ card.
• The ICF action labels have gone through an improvement.
• A back button to go back to the general Subject table has been added.
• The styling of the ‘Eligibility status’ label has been improved.

Other

• All new users are prompted to provide their first and last name during account creation.
• The user’s first and last name is now displayed on all audit trail events.
• The ICF signature header, signature statement and filled in full name are now displayed in the audit trail events “ICF signed” and “Consent form signed by subject in-person“.
• The general Subjects grid now also displays the subject eligibility status.
• The header menu now has a link to the Castor helpdesk page.
• The look of the Audit trail, Subjects and Consent Forms tables has been improved.

System defect fixes

A series of production defects have been fixed in this product update. A summary of these is below:

• Fixed an issue where the study status in the audit trail wasn’t showing the correct data.
• Fixed some styling issues in the audit trail in order to make sure all labels are readable.
• The User role field wasn’t showing as required when adding a new user to a study.
• Users are no longer able to interact with a locked consent form.
• The information message for subjects when the ICF is in a locked state wasn’t showing on smaller screens.
• The Country column in the Consent Forms table is displaying data again.
• The blue information message to subjects when the study team member ended a video call wasn’t always showing.

Minor release 2021.4.1

Released: January 4, 2022

System defect fixes

• Fixed: sending reminder emails from the EU server.
• Fixed: label change for an audit trail event related to viewing the ICF (information) to make sure the label represents the actual event better.

Improvements

• Subjects can view their study specific subject ID on their Dashboard as 'Personal subject ID'.
• Spanish, German and Dutch translations for some of email notifications to subjects are added.