Version Updates

With our minor release 3.1.0 we introduced an eConsent flow in Climedo, a new field type “mirrored fields” as well as some slider field improvements. See the most important updates below.

New Features & Improvements:

• eConsent flow: full integration of an electronic signature tool provider which allows users to conduct a fully remote signature process of the consent document (incl. configuration and upload of consent documents, definition of signees, signature request triggers). Furthermore, televisit solutions can be added to this flow.
• Mirrored fields: option to mirror a given value from a field in form A to form B. This new field type also enables calculations across forms.
• Slider: Several improvements, incl. an inactive state of the slider, the configuration of a default position and multiple design improvements.

Fixed:

• Audit Trail PDF shown collaborator name in “Printed by” property
• ePro history and query type property was removed from the survey PDF export
• corrected the progress calculation for tables
• etc.

You can view and download the release notes for the 3.1.0 version update here.

This hotfix version 3.0.3 includes performance improvements for the following areas: audit trail creation & dashboard widget loading.

You can view and download the release notes for the 3.0.3 version update here.

This hotfix version 3.0.2 includes fixes as listed below:

• Validations on (S)AE forms are now visible upon data entry
• Data is not saved when discarding changes in (S)AEs and unscheduled events

This list includes the main but is not limited to all fixes. You can view and download the release notes for the 3.0.2 version update here.

This hotfix version 3.0.1 includes but is not limited to the fixes below:

• Custom notifications now include PDF files if enabled for (S)AE events
• (S)AE overview should only show forms the user has access to
• (S)AE signatures reminder is only sent in case of missing signatures
• Single and multiple choice fields in the field type table/repeating fields now save data as expected
• Enable signing of unscheduled and sample events when table field is used in the form
• and more

This list includes the main but is not limited to all fixes. You can view and download the release notes for the 3.0.1 version update here.

In this major release 3.0.0 we introduced entirely new features and added improvements and bugfixes in several areas of the software, as listed below.

New Features:

• (S)AE 2.0: We improved our current (S)AE module by extending already existing core functionalities to (S)AEs, ensuring consistency across the system and allowing to set-up flexible workflow processes to facilitate the work for all parties involved. These changes include:
  • a new enhanced (S)AE overview, including the progress status per (S)AE as well the option to display custom fields which facilitate the navigation through the module. In addition, it is now possible to save and apply (S)AE filter queries to the overview.
  • in the new forms and workflow configuration area of the study, users can now create and integrate multiple (S)AE forms to be filled by sites
  • core functionalities such as locking, excluded collaborator roles or template sharing is now also enabled for (S)AE forms
  • for each study, the condition for when an adverse event is defined as serious, can be defined
  • pre-filled fields in the (S)AE form allow to display already collected data in the (S)AE form
• Wearables: It is now possible to integrate wearables data as additional source of data collection into a study. Data collection via wearables is focused on activity data, including step count, distance, heart rate and sleep duration. This data can be viewed and visualised via graphs in the wearables module per subject .
• Table / Repeating Fields: We extended the table input field with the following functionalities:
  • The option to create validations, notifications and dependencies on column level
  • Switch between the table and the repeating fields view
  • As further table customisations, users can limit the amount of rows / field groups that can be added by the fill-out user, use custom button-naming options
  • A new horizontal table export format, which provides the possibility to export tables in a separate tab, displaying the table layout similar to how it is shown in the system
• Automated Queries: We introduced the automated queries feature as part of the validation settings (step 5), with which query conditions can be pre-defined and queries are automatically opened when the condition(s) becomes true.

You can view and download the release notes for the 3.0.0 version update here.

With our hotfix release 2.2.1 we released one fix related to the data collection of numeric values, allowing users to enter and save the value “0” again in number field types.

You can view and download the release notes for the 2.2.1 version update here.

With our minor release 2.2.0 we introduced some performance and feature improvements as well as bugfixes for multiple areas of the system. See the most important updates below:

New Features & Improvements:

• Loading speed improvements for loading the subject overview, filtering for subject and study data, opening and filling ePros
• Option to deactivate collaborators and main users from the user overview
• Updated redirection link to the Data Privacy Notice on the login page of an instance

Fixed:

• Show survey entry archive event as well as query events in the subject audit trail
• Number field fixes: allow to enter a comma and block value change when scrolling
• Reduced the logo size in PDF export to decrease the overall file size
• Exporting subjects from a filtered subject overview and with multisite access is possible again
• Users with respective rights and access should be able to archive any created (S)AE

You can view and download the release notes for the 2.2.0 version update here.

With our hotfix release 2.1.1 we released one fix related to a hierarchical signature setup, allowing users with according signature rights to sign forms again.

You can view and download the release notes for the 2.1.1 version update here.

This minor release 2.0.1 comes with new functionalities and improvements on our export module as well as fixes in multiple areas of the system, as listed below.

New Features & Improvements:

• The Subject Audit Trail Export in PDF format is now available as a premium feature in Climedo. All users with respective export rights in the project set-up have the option to export via the “Data export” module. This file includes all audit trail logs created for a subject during the course of the study.
• For main users it is now possible to draw a Main User Export in Excel format from the main user overview. This file contains user information as well as an overview of his/her access rights.
• It is now possible to export all roles that have been set-up in a study. The previously existing collaborator export only includes the relevant role information of selected collaborators.
• The Export Naming Logic has been made consistent for all export files.

Fixed:

• The search for a subject ID in the subject overview was enabled again
• Audit Trail: users can now view audit trail events of archived sites; grouping of field & form added events in the audit trail overview; adding form and step information for locked/signed events in the detailed changes
• Exports: the survey export as well as the unscheduled events export now display the subjects that have been selected for export; the additional zip file inside a CSV export zip file is removed; the annotated PDF now shows the correct set-up of tab dependencies, overlapping text issues have been fixed and the (S)AE form is now again visible;
• Unscheduled: reference data update

You can view and download the release notes for the 2.1.0 version update here.

As part of the hotfix release 2.0.2, the following fixes were introduced:

• A user can only view scheduled/unscheduled/sample events of which his/her role is not excluded from
• Validations on date (and time) fields considers today's date as trigger for comparisons with "Today”
• Spelling error update

You can view and download the release notes for the 2.0.2 version update here.

This hotfix release 2.0.1 comes with mainly fixes and minor improvements, as listed below.

Improved:

• The system performance has been improved, which results in an increase of loading speed for the following areas: Progression and benchmarking widgets
• Study entry overview and switching between forms
• Validations and custom notifications (in study setup step 5)
• Advanced filter widget in the subject overview
• Subject overview is now accessible via the navigation side-bar for study dashboard and documents & files.
• Smart field: Possibility to use operators within numeric formulas and smart field updates are excluded from the reason for change feature.

Fixed:

Several smaller issues within the following areas have been fixed:

• Audit trail: Order in scheduled event forms now follows the workflow logic and audit trail filter dropdown options only show enabled modules.
• (S)AEs: Updated notification link redirecting to the respective (S)AE event.
• Subject information: Email and landline phone (if filled in) are now again shown in the ****export.
• Widgets: The fill-out statistics widgets now works for all studies and surveys without having to select a specific project.
• User roles: The subject profile button is now shown to users with read subject information rights. Users that only have read rights for input form management are now able to open the field details to see existing fields and the update button.
• Closed queries in forms can now be viewed via the “view query” dropdown option.
• Custom notification: For every enrolled patients only one CN is sent (if previously configured). This also applies to the re-enrolment of subjects.

This list includes the main but is not limited to all changes. You can view and download the release notes for the 2.0.1 version update here.

This major release 2.0.0 comes with main changes to our system structure, improved and entirely new features, as listed below.

Changes & improvements:

• The patients, (S)AE and samples module, previously modules on instance level, have been moved underneath a study, now presenting sub-modules of a study. Thus, all study relevant events and information are linked to its respective subject within a study.
• Collaborator rights access (sites, roles, management rights) and input form set-up, previously on instance level, can now be managed within a project (study or survey).
• User rights are now configurable on a more granular basis, differentiating between main users (instance rights) and collaborators (users with project access). In addition, distinguishing between site rights (i.e. subject-specific rights) and management rights (i.e. project configuration rights) within a project is now possible.
• The new audit trail layout for the subject audit trail per project will make it easier for users to view and filter for the information needed.
• Navigation and project set-up flow are adapted based on the new structure, (sub-)modules activated and customized project configurations. These changes, also referred to as the Isolated Project Cosmos (IPC), will enable our customers to manage multiple projects with different partners within the same instance and at the same time.

New Features:

• Dashboards:
  • The progression widget allows users to see the development of a subject's data points (e.g. lab parameter) captured over time (e.g. across multiple study visits).
  • The benchmarking widget helps to compare a defined data point of a subject to the values of the study's subject population. Benchmarking can be performed for one specific point in time as well as for the entire or filtered study population.
• A new field type, the smart field, performs automatic real-time processing and calculation of a subject’s data based on a configurable syntax logic.
• Export of collaborators per study including assigned site and management roles.
• Configurable enrolment screen per study.
• And many more!

Fixed:

• This update contains multiple fixes in all areas mentioned above, please find all details in the release notes.

You can view and download the release notes for the 2.0.0 version update here.