Major Release eConsent 2024.1.0.0

Release dates

EU server: March 6, 6 pm CET / 12 pm ET

US server: March 7, 9 am CET / 3 am ET

New features and enhancements

• A study team member with PII rights can withdraw a participant from the participant detail page. An Audit Trail Event will be logged to document this change. Following the withdrawal, both the participant and the study team member will have access restricted to actions equivalent to those allowed for an archived participant.
• The consent status of the participant changes to 'Withdrawn' when they are withdrawn from the study.
• When processing the withdrawal of a participant, a date of withdrawal has to be selected which reflects the actual withdrawal date of the participant. This date is then also included in the Audit Trail Event that is logged.
• Within the study settings, a study administrator can toggle the 'Reason for withdrawal' setting. When turning this setting on, a reason must be provided when withdrawing the participant. Next to that, the administrator can configure the reasons an investigator can choose when withdrawing.
• When withdrawing a participant, the study team member is able to select a pre-configured reason of withdrawal. After confirmation, the reason of withdrawal is added to the audit trail event.
• When withdrawing a participant, a study team member can choose 'Other' as a reason for withdrawal. This allows them to fill in a custom reason in a text field.
• A study team member with PII rights can undo the withdrawal of a participant. An Audit Trail Event will be logged to document this change. The study status will change back to the original status of the participant and the restricted access is removed from the participant record.
• When withdrawing a participant, the study team member can decide to send an automatic confirmation email to the participant after the withdrawal is processed.
• A study team member with PII rights can withdraw a participant from the participant list.
• Withdrawn participants are hidden from the participant overview by default. They can be shown by turning on the 'Show withdrawn participants' in the filter menu.
• The participant detail export now includes two columns around withdrawal: 'Withdrawal reason' and 'Withdrawal date'.
• After being withdrawn, participants have the same type of access as archived participants. They can view the study, their documents and their participant details. However, they can not change anything or sign any documents.
• An active participant can either be withdrawn or archived. After withdrawing, a participant can not be archived anymore and vice versa.
• When withdrawing a participant record with a LAR attached to it, the study team member will be asked if the LAR should be notified instead of the participant.
• When withdrawing a participant, the question about asking to notify the participant is deactivated in case there is no email present. Next to that, if there is a LAR added then the question phrasing is changed to ‘Send email notification to LAR?’ instead of ‘Send email notification to LAR?’.

• Castor staff is able to configure a client-provided video that will be shown on the study dashboard of the participant. This allows the participant to be informed about the study without having to read through a lot of text.
• When registering for a study as a participant, the date of birth field is pre-filled with today's date. To prevent participants from skipping the field, they will have to select another date in order to save their registration.
• When downloading a document that is signed by the participant, the file name will use the following format: '[Screening ID]_[ICF-Name]'. For documents that are unassigned or unsigned by the participant, the file name will use the following format: '[ICF-Name]'.

System defect fixes

• Fixed an issue where the order of LAR relationship answer options would change when changing other elements of the ICF.
• Fixed an issue where fonts and font colors could look different between the web version and pdf version of an ICF.
• Fixed an issue where study team members without PII rights were able to search and find participants when they filled in the participants' full email address.
• Fixed an issue where study team members without PII rights could see empty data fields in the 'Participant edited' audit trail event. They weren't able to see it when it contained data, but the field should say 'Restricted access' regardless of data being present or not.
• Fixed an issue where archived participants without an account would not be able to access the study.
• Fixed an issue where using a password manager was not possible when providing credentials during the signing process.

Minor Release 2024.1.2

Release date

EU & US servers: May 16, 9 AM CET / 3 AM ET

New features and enhancements

• The flow to reset your password has been made more user-friendly. The flow can now be initiated by pressing the 'Change password' button on the account settings page.

System defect fixes

• Fixed an issue where in some cases an email would not be send to the participant when re-inviting them to sign an ICF they have signed before.

Hotfix Release 2024.1.2.1

Release date

EU & US servers: May 22, 2:30 PM CET / 8:30 AM ET

System defect fixes

• Fixed an issue where in some scenarios the links in invitation emails for new users would redirect to to the log in page instead of to the registration page.
• Fixed an issue where new API service accounts would not be able to use the eConsent API.

Maintenance Release 2024.1.3.0

Release date

EU & US servers: August 22, 3 PM CET / 9 AM ET

New features and enhancements

• Various technical improvements to allow for better configuration of study settings.

Maintenance Release 2024.1.4.0

Release date

EU & US servers: September 23, 9 AM CET / 3 AM ET

New features and enhancements

• We've improved the consent process to make it more user-friendly and accessible. Now, you can type your signature on consent forms. This will be the default signing method, but you'll still have the option to switch to drawing your signature if you prefer.
  
  By default, this feature will only be available for new studies. However, if you'd like to use it for an existing study, please contact our Support team, and we can enable it for you.
• We localized the placeholder text on the study profile registration page so the examples are better fitting to the language that is selected.
• Various technical improvements to allow for better configuration of study settings.

Maintenance Release 2024.1.5.0

Release date

EU & US servers: September 16, 9 AM CET / 3 AM ET

New features and enhancements

• Various technical improvements to allow for better configuration of study settings.