Changelog

Version 3.11.0 (23/07/2025)

  • Project/Settings: added study type and therapeutic fields.
  • Account Settings/Centers: added coordinates field in center edit.
  • Ide/Editor: added support for CDASH encoding.
  • Administration tools/Advice: Added new CDASH and Musa modules.
  • Account Settings/Roles: added download of the allowed roles matrix.
  • Audit/Trail: added role-permission tracking.
  • CDASH/Create: added new section for creating new CDASH terms.
  • User: added flag to creare user service.
  • Export: fix issue on dm export.
  • Export: fix issue on not visible form export.
  • Ide/Editor: fix issue on the possibility to make autoapprove equery.

Version 3.10.1 (26/06/2025)

  • Generic: Upgrade to Laravel 12.
  • Export: Fix issue on export of deleted related data.
  • Export: Fix issue on download saved forms not visible.
  • CRF: Fix possibility to do equery on closed patient.

Version 3.10.0 (05/06/2025)

  • Export: Added row_number column to export monitoring file.
  • Generic: Fixed issue with deleted urv selection.
  • Randomization and Users: Added button to download import template file.
  • Clinical study/eCRF: Added permission to create patients.
  • Uploader component: Added confirmation modal for file uploads.
  • Administration tools/Advice: Added new rtsm module to medical kits.
  • Administration tools/Advice: added kit threshold setting for low stock notification, if rtsm is active.
  • Rtsm: added a new section to create medical blocks and manage their states.
  • Ide/Editor: added a new attribute on the randomize button for replacing the medkit assigned to the patient during randomization.
  • CRF:added ability to upload large files.
  • Audit/Audit status kits: Added a new audit that tracks the changing statuses of medical kits.
  • Project/Settings: added double blind button to hide medkit processing.
  • Project/Settings: added medical kit double chck button to enable double checking of medical kit states.

Version 3.9.2 (15/04/2025)

  • Export: export tables problem solved.
  • Projects/Settings: Fixed issues with save and refresh emptying fields.

Version 3.9.1 (09/04/2025)

  • Generic: Fixed issue with sending credentials after tenant publishing.

Version 3.9.0 (31/03/2025)

  • ePRO: Added epro module.
  • CRF: Improvement of audit and eQuery functionalities
  • CRF: temporarily disabled visible tree discrepancies due to loading issues

Version 3.8.3 (27/01/2025)

  • CRF: General fix for query and trigger processing.
  • Export: Correct data staggering.
  • CRF/data Discrepancies: fixed the match on urvs.
  • CRF: Corrected the problem on tables where row deletion did not correctly eliminate possible medical or drug coding.

Versione  3.8.2 (13/01/2025)

  • Event mail: Added carriage return.
  • Audit: Fixed problem on filter.
  • CRF: Fixed conditions and triggers on component visibility before saving form.
  • CRF: The data of the forms saved as drafts are deleted following a structural change.
  • Export: Added idx_urv for exports grouped by visit.
  • Export: Fixed row_number in export files.

Version 3.8.1 (18/12/2024)

  • CRF/data discrepancies: Fixed the return of components that have discrepancies.
  • CRF: Added closing of equery pending on urvs which are eliminated.
  • CRF: Blocked saving the query on disabled components.
  • CRF: Removed reporting of required/warning components on deleted urvs.
  • CRF: Fixed visible conditions.

Version 3.8.0 (11/12/2024)

  • Generic: Added jwt token login.
  • CRF/data discrepancies: Added new section that tracks discrepancies on CRF components.
  • CRF: Added recalculation of conditions in equery.
  • CRF: Added required boxes on components.
  • CRF: Table data is deleted when it is disabled.
  • Protocol deviation: Added new protocol deviation section that keeps track of queries opened in this way.
  • CRF: Added the ability to open protocol deviation query comments.
  • Ide/Editor: Added the ability to mark queries as protocol deviations in triggers and warning conditions.

Version 3.7.2 (10/10/2024)

  • Generic: Added maximum file size upload management.
  • Audit/Generic: Added generic audit for ide and patient crf printing.

Version 3.7.1 (02/10/2024)

  • Ide/Editor: Fixed checking of file format when loading it.
  • Generic: Code improvements on new features.
  • Ide: Improvements on hard lock label and memory leak.
  • Export: Fixed a bug on export when grouping by visits.

Version 3.7.0 (23/09/2024)

  • Ide/Editor: Added a new apibutton component, visible only via permission.
  • Administration tools/Advice: Added new button that enables visibility permission of the new apibutton component.

Version 3.6.8 (19/08/2024)

  • CRF: Fixed emptying of field on condition.
  • CRF: Added error return on upload files that are too large.
  • Ide: Added option to hide component labels.

Version 3.6.7 (09/08/2024)

  • CRF: Fixed check/uncheck button for table component monitor.
  • Mail: Added a new mailer to send emails using the mailup api.
  • Equery: Fixed equery pending on removed table row.
  • URV Grid: fixed visualization bugs.

Version 3.6.6 (05/08/2024)

  • Ide/CRF: Numeric components now rendered without increase/decrease arrows.
  • CRF: Fixed a bug on Upload component when downloading crf files.
  • Medical/Drug coding: Added download button.
  • Codebreaking: Fixed a section visibility bug.
  • Export: Fixed a bug on URVs when grouping by visits.

Version 3.6.5 (29/07/2024)

  • Ide: Added single form optimization.
  • Medical/Drug coding: Fixed search values with ‘/’ character.

Version 3.6.4 (16/07/2024)

  • Permission: Fixed bug on IDE permission.
  • CRF: Fixed label alignment and multimedia label.
  • Medical/Drug coding: Optimized search function.
  • Update: Performance and security improvement.

Version 3.6.3 (27/06/2024)

  • Import clinical data: Fixed bug on importing data into tables.
  • Import CRF: Optimized management of event-email.
  • Administration Tools: Fixed bug on placeholders’ selection.
  • Ide: Optimization of component’s properties.
  • Patient Grid: Addition of progress-bar color for signed patients.
  • Print: Process optimization.
  • Login: Fixed bug on password change.
  • DM Export: Optimized ordering of data.
  • Monitor: Fixed bug on pdf visualization.
  • Audit: Improved system performance.
  • Equery: Optimized equery management on computed component.

Version 3.6.2 (11/06/2024)

  • Monitor: Fixed a bug on urv monitoring

Version 3.6.1 (06/06/2024)

  • Export decoded: Fixed a bug on forms/visits name
  • Print PDF: Optimization and fix on IDE print.

Version 3.6.0 (30/05/2024)

  • Drug Coding: Added drug coding functionality
  • User: Added “Associate all centers” option for users
  • Equery: Fixed save button behaviour
  • Export Clinical Data: Optimization
  • Randomization: Added permission check for randomization button
  • Medical Coding: Fix and optimization
  • Print PDF: Optimization

Version 3.5.4 (07/05/2024)

  • Export: fixe sas metafile
  • Export Clinical Data: added patient list file
  • Audit Trail: fixed visualization in form
  • Print IDE: Optimized management of component attributes
  • Export DM: Optimized management of component attributes

Version 3.5.3 (15/04/2024)

  • Equery: Resolved issue with “verify” button in URV
  • Equery: “Save” button disabled during equery generation
  • Equery: Equery on a triggered component no longer updates the enable status
  • Export: Added patient-info file to the Data Export.

Version 3.5.2 (09/04/2024)

  • Medical Coding: Fixed coding on component on deleted row of tables
  • Medical Coding: Fixed audit
  • Patient Grid: Added status patient to the export
  • DB Lock: Changed logic from “OR” to “AND”.

Version 3.5.1 (04/03/2024)

  • Codifica medica: aggiunta distinzione per il termine primario.

Version 3.5.0 (13/02/2024)

  • Esportazione: aggiunta nuova funzionalità per l’export dei dati in formato SAS.

Version 3.4.2 (12/02/2024)

  • Equery: corretto accesso ai dettagli delle equery dalla sezione archivio equery.

Version 3.4.1 (24/01/2024)

  • Editor: Fixed controls on names
  • Normal Range: Fixed condition’s generation
  • Export CSV: Changed delimiter from ‘,’ to ‘;’
  • Hardlock: Now correctly locks also centers, project configuration, any modifying action in editor.
  • Softlock: No longer available if there are pending equeries on the selected value.
  • Equery: Fixed a bug when filtering equery by ID in equery archive.
  • Equery: Equery autoapproved are now correctly shown as verified

Version 3.4.0 (23/11/2023)

  • Helpdesk: Opening tickets from within ICE3
  • Event email: Improved use of ‘component value’ events

Version 3.3.2 (08/11/2023)

  • Stampa PDF: corretta stampa su IDE annotati, risolta stampa di etichette in tabelle e stampa URV dei pazienti eliminati.

Version 3.3.1 (02/11/2023)

  • Conditions: Fix compute and normal range
  • Permission: Fix IDE permissions
  • Equery: Fix equery generation on normal range

Version 3.3.0 (26/10/2023)

  • Survey: introdotta nuova sezione “Patient Survey” collegata all’applicazione Limesurvey.

Version 3.2.0 (16/10/2023)

  • URV Grid: Added a new section to better display all the compiled URVs form of a patient
  • Import clinical data: Added system for massive import of clinical data
  • Project Settings: Projects name can now be longer
  • Editor and Trial interfaces: Optimized both interfaces, no more overlapping elements!
  • Conditions: Fix on condition creation an management on elements duplication, on condition urv pointers. on compute elements, on normal ranges, and overall fix on system variables
  • Upload Component: Fixed equery on upload components
  • Medical Coding: CTCAE should now work accordingly
  • changelog.change_3.2.0_8

Version 3.1.3 (13/10/2023)

  • Conditions: Fixed system variable. Fixed datetime diff. Warning mesagge is now mandatory
  • Medical coding: Now tracked also the searched term. Fixed CTCAE
  • Equery: Added equery option for Uploader components. Fixed date format
  • Checkbox: Fixed option ‘required’ on checkbox
  • Print: Optimized print patient and print editor

Version 3.1.2 (28/07/2023)

  • Export: Optimization of DM-export
  • Conditions: Fix condition’s management on duplication. Fixed conditions in tables
  • Audit: Broadened tracking for audit-generic
  • Component library: Fixed condition management

Version 3.1.1 (25/07/2023)

  • Numeric component: Added option for 1 decimal
  • Maintenance: Admin user can now activate the maintenance for the study
  • Conditions: Fixed conditions in URV. Fixed compute with null value. Fixed errors on datetime conditions
  • Editor: Fix form properties
  • Equery: Add verify status to export
  • Sign patient: Add checks for equery pending and closed patient
  • Normal range: Fixed evaluation of conditions when component disabled.

Version 3.1.0 (12/07/2023)

  • Audit trail: Audit trail is subject only to soft-delete. Added tracking of download of eCRF uploaded files
  • eCRF validation: Added flag to identify the validated CRF
  • Condictions: Fixed required, visible, compute and warning check
  • CRF Tables: Fixed table’s management and evaluation of triggers and condictions
  • Helpdesk: Optimized access to support links
  • Editor: Fixed print filters
  • Tables: Optimized use of delete actions.

Version 1.2.1 new updates (12/11/2025)

  • Upload Document: Added error message for documents exceeding the allowed size.
  • Tree view: added the color legend of the tree studies.
  • Audit Trail: Fixed the issue with the studios filter messing up other filters.

Version 1.2.0 new modifications and features (15/10/2025)

  • Users: added the ability to associate users with the study centers they belong to.
  • Upload documents: you can only upload documents for centers you’re associated with. Documents will be visible based on your permissions.
  • Tree view: if a tree element is selected and the upload button is pressed, the fields will be automatically pre-filled.
  • Users List: you can now delete and restore users.
  • Role/Permissions: Added new permission to associate user-study.
  • Added permission to export documents to the default sponsor role.
  • Audit Trail: name of closed practice made visible.
  • User/Create: added the ability to create a new user without an associated study.
  • Tree view: added color to folders to distinguish empty ones from those with content
  • Added the ability to choose whether to see default roles or not when creating clients.
  • Added the ability to set a maximum number of studies that can be created in the client.
  • Support: added link to Knowledge Base.
  • Support: added a new Changelog section to show version changes.

Versione 1.2.0 Bug fix (18/12/2024)

  • Implemented the flow for the closure and the approval of the studies.
  • Backend: The possibility of closing a study through an external API is added.
  • Added Google reCAPTCHA v3 in the “Password forgotten ” page e validated the captcha in the backend
  • Modificato il controllo della dimensione massima dei file, ora verifica il php.ini e convalida anche il frontend
  • Esportazione di documenti, report CSV e voci di database per singoli studi
  • Esportazione di documenti per zone, sezioni e reperti
  • Esportazione dei ruoli in formato CSV
  • Esportazione del log di audit in formato CSV
  • Backend: Aggiunta l’attivazione del flag SESSION_SECURE_COOKIES
  • Backend: Corretto il problema delle sezioni duplicate durante la migrazione

Version 1.1.0  bugfix (10/10/2024)

  • Frontend bugfix: Fixed bug that redirected users to login when inserting OTP with two tabs ope

Version 1.0.1 bugfix (02/10/2024)

  • Frontend bug fix: fixed an issue that redirected users to the login page when entering the OTP with two tabs open
  • Fixed: resolved the issue related to custom email objects

Version 1.0.0 (03/09/2024)

  • The Electronic Trial Master File is a digital archive for the most relevant documents of a clinical trial
  • Accessible via next-generation cross-platform browsers (MS Edge, Chrome, Firefox, and Safari)
  • Designed in compliance with the “Trial Master File Reference Model Version 3.2.0 – November 2, 2020” proposed by the Drug Information Association (DIA)
  • Enables the management of clinical trial documents: upload, review, approval, or rejection by users with specific roles
  • Workflow customization for each role with specific permissions
  • Provides complete tracking of the audit log

Version 1.0.2

  • Fixed an issue related to missing or incorrect data display in the dashboard.
  • Fixed an issue related to centers and their association with patients and the tenant.
  • Fixed an issue concerning the tenant used during questionnaire association.

Version 1.0.1

  • Fixed issues related to the compilation and translation of certain values in the questionnaire.
  • Fixed an issue concerning the association of questionnaires with the patient.
  • Fixed bugs related to optimizations.

Version 1.0.0

  • Initial release.

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