Released: 25 August 2021
Added features/functionalities
In-person signing
eConsent now supports hybrid consenting procedures. Besides the support of remote consent via embedded video calling, consenting can also take place via the in-person signing process. When the subject signs in-person they are not required to create an eConsent account.
- Study setting ‘In-person signing’ is added to enable the in-person signing process.
- The in-person signing process is started by the user that is conducting the consent procedure by selecting the ‘Sign in-person’ ICF option from the subject.
- The study team member that is conducting the consent procedure first has to confirm the subject's identity before the in-person signing could kick off. This identity confirmation step is logged in the audit trail.
- When handing over the device to the subject, the subject can directly sign the ICF without having to create an eConsent account.
Screening ID automated generation
Besides screening ID, a second subject identifier, subject ID, is added. Screening ID's can now be generated automatically by the system.
- A field to collect the subject ID is added.
- A study setting to let eConsent automatically generate screening ID’s is added. Site abbreviation, a separator, and the number of digits are configurable when enabling automatic screening ID generation. When this feature is enabled, no manual entry of screening ID’s is allowed.
- A study setting to copy over the screening ID into the subject ID is added for studies that do not make a distinction between these two identifiers.
Eligibility
Subject eligibility can now be captured in eConsent.
- A study setting ‘Eligibility field’ is added to enable the collection of your subject eligibility status (available statuses are pending, pass, and fail) including the timestamp of when this was updated.
- The eligibility status can be updated manually, or automatically based on the outcome of a screening survey that is filled in by the subject (see next section about integrations and data exchange).
Integration with enrollment portal and data exchange with Castor EDC
The integration with study specific enrollment portals and data exchange between Castor EDC is revised, in order to better support the main patient enrollment processes.
- Our customized study specific enrollment portals are now directly integrated with eConsent. Subject email address and, if applicable, study site is pushed from the enrollment portal to eConsent.
- Subject record creation can trigger the sending of a screening survey in order to define whether the subject is eligible for study participation. The eligibility outcome from the survey is displayed in eConsent. If the subject is eligible, the e-mail invitation to review the ICF will be sent to the subject automatically.
- Once the ICF is signed, eConsent can trigger record creation in Castor EDC, including the exchange of the subject site (institute) and subject email address.
Toast messages
System feedback is communicated via the new addition of green success and blue information toast messages.
Improved & extended features/functionalities
Consent forms
- The IRB-EC approval date can be collected for each ICF.
- The time stamp of the added ICF signature that is displayed on the PDF version of the ICF is now also displayed on the web/html version of the ICF.
- The ‘Clear’ button linked to the ICF signature only clears the entered signature, instead of both signature and full name.
- The size of the red asterisk to mark the required ICF tick boxes on the is increased.
Subject profile page
The subject profile page that is displayed when opening a subject record has gone through a complete redesign by implementing card components.
- The following card components are added: Subject profile, Consent information, Personal details, and Video call.
- Linked ICFs are removable from the subject via the ‘Remove’ action.
- Field ‘Created by’ is added to the subject profile
- Field ‘Country’ is hidden from the subject profile
- The table that displays the linked ICFs is moved to a new ‘Consent forms’ tab.
- The ‘Video calls’ tab is removed as it is replaced by the ‘Video call’ card on the Subject profile.
Other
- Configurable email notification triggered by subject record creation is added.
- The interaction with the main menu/navigation bar is improved.
- An information banner ‘Your call has started, please join the call.’ is showing for the subject once the investigator has started the consent call.
- Studies in the status ‘Live’ are opening in the ‘Subjects’ overview by default.
- The ICF version number and/or date is displayed in the ICF picker field when assigning an ICF to a subject.
- Subject invite statuses ‘Pending invite’ and ‘Accepted’ are changed into ‘-’ and ‘Active’ respectively.
- Site abbreviation has to be between 2 and 6 characters and cannot longer contain a space. These rules are implemented as the site abbreviation can be used in the automatic screening ID creation.
System defects fixes
A series of production defects have been fixed and included in this product update. A summary of these is listed below:
- Fixed a defect where ICFs from other sites were showing when linking additional ICFs to a subject.
- ICF version date and version number can no longer be edited once the ICF template is published or archived.
- The required ICF tick boxes are now marked with the red asterisk in the preview modus and PDF version.
- Bold styling in the ICF signature statements wasn’t reflected in the PDF download of the ICF.
- Subject site and language are editable again.
- The email address input field on the login and sign up pages is no longer in italic.
- Users with a ‘study’ role weren’t showing for users with a ‘site’ role.
- Consent status ‘Incomplete’ is now shown in the general Subjects overview if there is at least one ICF for that subject in that status.
Minor release 2021.3.1
August 26, 2021
Only technical improvements are implemented in this version, there are no functional changes for users.
Minor release 2021.3.2
September 3, 2021
System defect fix
- Fixed a defect where in specific video call scenario's the users were not able so see and/or hear each other.
Minor release 2021.3.3
September 9, 2021
System defect fix
- Fixed a defect where is wasn't possible anymore to upload a study logo.
Minor release 2021.3.4
September 10, 2021
Only technical improvements are implemented in this version, there are no functional changes for users.
Minor release 2021.3.5
September 16, 2021
Improvements
- Technical improvements are made that enhance the speed of the general Consent forms tab and the data exchange between Castor eConsent and Castor EDC
Minor release 2021.3.6
September 20, 2021
Improvements
- Technical improvements are made that enhance the speed of signing large sized consent forms.
Minor release 2021.3.7
September 29, 2021
System defect fix
- Fixed a defect where in specific video call scenario's the subject wasn't able to join a video call.
Minor release 2021.3.8
October 10, 2021
System defect fix
- Trigger to create a subject record in Castor EDC can now be configured as well for the consent form status "Consented".
Minor release 2021.3.9
October 22, 2021
System defect fix
- Fixed a validation issue with in-person signing.
Minor release 2021.3.10
October 28, 2021
System defect fix
- Fixed a security issue.