Version Updates

This hotfix version 4.1.8 includes the following:

• The configuration of eConsent reminders should be optional
• The signature hierarchy for eConsent can be set

You can view and download the release notes for the 4.1.8 version update here.

This hotfix version 4.1.7 includes following fix:

• The progress of the ePro is now accurately calculated as the “tabTemplatesDictionary” cache receives the most recent state of the fields

You can view and download the release notes for the 4.1.7 version update here.

This hotfix version 4.1.6 includes but is not limited to the fixes below:

• Smart fields are calculated in real-time again for ePro and survey entries
• ePro invitation links were shortened to the initial length
• The collaborator export is working again with all correct information

You can view and download the release notes for the 4.1.6 version update here.

This hotfix version 4.1.5 includes but is not limited to the fixes below:

• Loading speed was improved for loading the subject overview, switching between forms and study steps within a subject as well as data entry & saving
• The simultaneous data entry on the same subject in ePro and eCRF is now possible
• Smart fields will be calculated in real time again within an ePRO
• The export is working regardless of the number of subjects that is being exported

You can view and download the release notes for the 4.1.5 version update here.

This hotfix version 4.1.4 includes the fix below:

• ePRO emails should be sent even if the SIC contains a blank space

You can view and download the release notes for the 4.1.4 version update here.

This hotfix version 4.1.3 includes the fixes below:

• Display labels in table cells do not longer overlap in ePro and survey forms
• Multiple choice fields are always loaded for ePro and survey users
• The site filter configuration is now saved on widget level, not user level
• By adding a loading screen to widgets allows to better manage user expectations

You can view and download the release notes for the 4.1.3 version update here.

This hotfix version 4.1.2 includes but is not limited to the fixes below:

• Missing required fields in the ePRO should not be highlighted directly after the value is removed
• When clicking the next button on ePRO, the user is being redirected to the next form of the workflow
• Widgets are only updated when the dashboard status is not “inProgress”
• Loading screen is shown as long as widgets are completely updated

You can view and download the release notes for the 4.1.2 version update here.

This hotfix version 4.1.1 includes but is not limited to the fixes below:

• Unfilled required fields in the ePRO are highlighted when saving
• The ePRO save button is not disabled after saving and guides the user to missing required fields
• The snack bar messages match the study language
• Exports are possible also if a form includes a table and the form name includes a hyphen (-)

You can view and download the release notes for the 4.1.1 version update here.

With our minor release 4.1.0 we introduced several new features, improvements and bugfixes. See the most important updates below.

New Features & Improvements:

• Dashboard improvements:
  • Benchmarking: option to filter the benchmarking dataset for the selected subject's site and to compare it to other sites
  • Progression: comparison of progression curves between individual patients, promoting a deeper understanding of the patient journey and identifying outliers that may require special attention.
  • Several widget types (medical data widgets, bar charts, pie charts or operational widgets such as fill-out statistics): option to filter the visualized dataset based on pre-defined smart filters for a more granular and customizable analysis.
  • Newly integrated rich text functionality allows study managers to structure the dashboards more effectively and share relevant information and descriptions. They can highlight important information, upload images and logos and share study-related news and updates.
• Translation Module: Fast and workaround-free configuration of multiple languages for ePRO and eCRF forms to provide support for multi-national studies
• Static Randomization: To ensure a smooth user experience for sites and data managers, the randomization allocation is now fully integrated into Climedo. A randomization list can be uploaded by the user which defines all available randomization slots in a study. This list is used by the system to allocate subjects respectively to the defined subgroups. With our rights management unblinded and blinded studies can be conducted.
• Other:
  • Hybrid Consent: Possibility to track both paper and eConsent inside a study
  • Setup of custom ePRO reminder messages
  • Container Migration: Technical improvements to ease the process of running migrations

Fixes:

• Several ePRO detailed overview display fixes
• Cells in tables can be marked as available / unavailable
• and many more!

You can view and download the release notes for the 4.1.0 version update here.

In this major release 4.0.0 we introduced entirely new features and added improvements and bugfixes in several areas of the software, as listed below.

Changes & improvements:

• ePRO, Self-Registration & Survey redesign and speed improvements:
  • 40% faster loading time when loading ePRO and survey forms
  • Redesign of all ePRO and survey screens
  • ePRO infrastructure improvements
• Other:
  • Significant performance improvements of large scheduled events exports
  • Upload of .t3d and .drc file format to climedo is now possible
  • Improvements in display of ePRO scheduling end send dates in eCRF and ePRO detailed overview
  • Benchmarking and progression widget improvements:
    • Display of option labels for benchmarking filter options
    • Filter dropdown: Ascending sorting by SIC

Fixes:

• Custom notifications are sent when triggered by ePRO user
• SIC is visible in subject selection dropdown for benchmarking & progression widget and data of the widgets is only shown to collaborators with the respective access
• and more

You can view and download the release notes for the 4.0.0 version update here.

With our hotfix release 3.5.1 we released one fix related to improve stability and efficiency of the system by stopping overload of queues in RabbitMQ.

You can view and download the release notes for the 3.5.1 version update here.

With our minor release 3.5.0 we introduced several new features, improvements and bugfixes. See the most important updates below.

New Features & Improvements:

• Dashboard & widget improvements: The benchmarking and progression widget will be available for single select field types, allowing users to visualize a subject’s progress on quality of life questions, for example. In addition, several user guidance improvements are being implemented, as well as the option to expand the information displayed for the benchmarking widget.
• ePro improvements: We are continuously improving the loading speed of the ePro form fill-out and saving process. In addition, a new ePro scheduling option will be introduced, where ePros can be triggered based on defined and collected date (and time) field data.
• Project duplication: Users will be able to copy studies and surveys with all configured forms, workflows, and trigger events, facilitating UAT preparations and amendment processes, as well as transitions from pilot studies to clinical trials.
• Other: Multiple special characters can now be used in the option labels of selection option fields such as single-select or multi-select fields; field types and option values for selection option fields are now shown in the form configuration view to provide a better overview to project configurators

Fixes:

• Audit Trail: no “Form update” events will be created upon (S)AE creation if forms have not been updated by the user; user will see all audit trail events where user has access to
• Widgets: Progression/Benchmarking widgets are not shown when user is excluded from the form the widget is based on; the sliding modal progression widget for dropped subjects will not load indefinitely
• Other: uploaded images in rich text fields are now shown correctly; fields that are marked as unavailable can now be verified using our SDV feature
• and many more!

You can view and download the release notes for the 3.5.0 version update here.

This hotfix version 3.4.3 includes but is not limited to the fixes below:

• Date, date and time, and partial date field are shown in a consistent format for CSV lambda exports
• Number fields are saved as number (not as a string) and formatted in the exports accordingly
• Updating the subject information of self-registered subjects is again possible

You can view and download the release notes for the 3.4.3 version update here.

This hotfix version 3.4.2 includes the fixes below:

• Removing data from certain field types should always create an audit trail log.
• For the internal study workflow export the following two fixes have been made:
  • All rows now include a tab name in the input fields sheet
  • ePRO columns for visit events should not be filled starting from the "send as" field

You can view and download the release notes for the 3.4.2 version update here.

This hotfix version 3.4.1 includes but is not limited to the fixes below:

• Negative decimal numbers between -1 and 0 should be allowed in number field
• Forms should get visible or hidden immediately after the data which should trigger the action was saved

You can view and download the release notes for the 3.4.1 version update here.

With our minor release 3.4.0 we introduced several new features, improvements and bugfixes. See the most important updates below.

New Features & Improvements:

• Source Data Verification (SDV): With this new function, the verification process can be documented in the input form and output in reports. During the study setup, the user can also select which fields are meant to be verified to enable a risk-based monitoring approach.
• Performance improvements: These improvements include faster loading of ePRO forms, saving new data entries in ePRO and eCRF or updating existing ones.
• Self-registration enhancements: The self-registration module has been further adapted to enable successful registration even after re-scanning the QR code. In addition, further security packages, as well as the specific audit trail events for this module have been added.
• Copy protection for ePRO questionnaires: In order to ensure conformity with the requirements of license givers, ePRO users will no longer be able to copy ePRO questionnaires or print them out via browser.

Fixes:

• Audit Trail: Several fixes were made to the audit trail. These include displaying the ePRO open event when ePRO is opened, showing a complete history of field-data changes in the field audit trail, and displaying all IDAT-related events in the audit trail.
• (S)AE: Fixes made for the (S)AE module include that the completion percentage of (S)AE overview is now in synch with subject overview, the changelog includes detailed information for create/update notifications, and (S)AE overview percentage is recalculated after changes in step 3.
• Self-Registration: Fixes related to self-registration include triggering the ePRO after the subject completes self-registration, removing the display of completion percentage for the contact form, and synchronizing selected IDAT fields and IDAT fields in the contact information form.

You can view and download the release notes for the 3.4.0 version update here.

This hotfix version 3.3.1 includes but is not limited to the fixes below:

• Successfully activate a study when the self-registration module is enabled
• Show the QR code generation option in the survey module
• Improve ePRO loading speed
• Allow choice fields to be removed if connected dependencies are deleted
• Ensure that the study overview synchronizes correctly after updates are made in ePRO forms

You can view and download the release notes for the 3.3.1 version update here.

With our minor release 3.3.0 we introduced several new features, improvements and bugfixes. See the most important updates below:

New Features & Improvements:

• One-device enrollment: The new "one-device enrollment" module allows enrollment of multiple subjects with the same contact information to a study, supporting the use of site tablets to fill out ePROs without the need for subjects to bring and use their own device.
• Bulk locking and signature: With this feature, you can lock or sign up to five subjects simultaneously with the option to filter by study step.
• Self-Registration: Patients have the convenience of self-registering to a study in Climedo, either by scanning a QR code or directly accessing the unique enrollment links. Once a link is scanned, it is tied to the patient's device for increased data safety. To ensure the patient has provided a correct email address and is willing to receive ePROs throughout the study, Climedo offers double opt-in.
• Performance Improvements: Improvements in system performance include faster loading of the subject overview, subject overview loading times, deletion of collaborators, audit trail search bar, and field audit trail.
• eConsent: Minor usability improvements include validation checks for required data entries and improved eConsent restart button behavior.
• Random SIC generation: It is now possible to use an alternative SIC format, which will be a randomly generated 8-digit combination of numbers and characters.
• Amendments: Improvements regarding the efficiency of study amendments. In addition, part of the study setup is now visible but non-editable in active studies.

Fixed:

• Several export-related fixes (No overlapping of (S)AE table of contents, 0 value is included in validation settings in annotated PDF, correct table row naming after name was changed)
• Mirroring of empty data to destination fields
• Several table fixes ("add new entry" and "bin symbol" are greyed out for ePRO form when it is open from subject overview, export of table use display labels for export)
• etc.

You can view and download the release notes for the 3.3.0 version update here.

The hotfix release 3.2.1 includes but is not limited to the fixes below:

• Improvement for uploading and visibility of files
• No query replication for activated studies
• “Updated at” timestamp in (S)AE overview is shown on (S)AE creation
• Improvement for table fields created before the enhanced table upate
• Improvement for large export requests

You can view and download the release notes for the 3.2.1 version update here.

With our minor release 3.2.0 we introduced several new features, improvements and bugfixes. See the most important updates below:

New Features & Improvements:

• Partial date entry is now possible in Climedo. Users can configure the accepted date formats for this new field type, thus still ensuring the collection of the required information.
• Answer option values will enable users to assign a numeric value to answer options and thereby greatly simplifies subsequent analyses. This feature will enable calculations based on answers of single choice and dropdown fields.
• The new report module enables to configure aggregated and customised exports in Excel format, thus facilitating study analyses and providing a summary overview to sponsors, monitors and data managers. A variety of configurable basis reports is provided, incl. reports for the subject status, subject enrollment, query status, (S)AE status, scheduled events (data count & exact data), and (S)AE exact data.

Fixed:

• Several table fixes (e.g. hidden columns not calculated into fill-out progress, display of entire value in date and time field)
• eConsent fixes (e.g. correct update of signee, audit trail events only visible to respective users)
• Slider fixes (e.g. correct display of ticks and slider values, reverting back to default position during mobile scrolling)
• etc.

You can view and download the release notes for the 3.2.0 version update here.

With our hotfix release 3.1.1 we released one fix related to the display of the correct number of subjects in the subject overview.

You can view and download the release notes for the 3.1.1 version update here.

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.