Versione 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.
Versione 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.
Versione 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.
Versione 3.9.2 (15/04/2025)
- Export: export tables problem solved.
- Projects/Settings: Fixed issues with save and refresh emptying fields.
Versione 3.9.1 (09/04/2025)
- Generic: Fixed issue with sending credentials after tenant publishing.
Versione 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
Versione 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.
Versione 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.
Versione 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.
Versione 3.7.2 (10/10/2024)
- Generic: Added maximum file size upload management.
- Audit/Generic: Added generic audit for ide and patient crf printing.
Versione 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.
Versione 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.
Versione 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.
Versione 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.
Versione 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.
Versione 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.
Versione 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.
Versione 3.6.2 (11/06/2024)
- Monitor: Fixed a bug on urv monitoring
Versione 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
Versione 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
Versione 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.
Versione 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”.
Versione 3.5.1 (04/03/2024)
- Codifica medica: aggiunta distinzione per il termine primario.
Versione 3.5.0 (13/02/2024)
- Esportazione: aggiunta nuova funzionalità per l’export dei dati in formato SAS.
Versione 3.4.2 (12/02/2024)
- Equery: corretto accesso ai dettagli delle equery dalla sezione archivio equery.
Versione 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
Versione 3.4.0 (23/11/2023)
- Helpdesk: Opening tickets from within ICE3
- Event email: Improved use of ‘component value’ events
Versione 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.
Versione 3.3.1 (02/11/2023)
- Conditions: Fix compute and normal range
- Permission: Fix IDE permissions
- Equery: Fix equery generation on normal range
Versione 3.3.0 (26/10/2023)
- Survey: introdotta nuova sezione “Patient Survey” collegata all’applicazione Limesurvey.
Versione 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
Versione 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
Versione 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
Versione 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.
Versione 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.
Versione 1.1.0 correzione bug e nuove funzionalità – 04/02/2025
- 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
Versione 1.0.2 correzione bug – 10/10/2024
- Correzione bug frontend: risolto un problema che reindirizzava gli utenti alla pagina di login quando inserivano l’OTP con due schede aperte
Versione 1.0.1 correzione bug – 02/10/2024
- Correzione bug frontend: risolto un problema che reindirizzava gli utenti alla pagina di login quando inserivano l’OTP con due schede aperte
- Corretto il problema relativo agli oggetti email personalizzati
Versione 1.0.0 – 03/09/2024
- L’Electronic Trial Master File è un archivio digitale per i documenti più rilevanti di una sperimentazione clinica
- Accessibile tramite browser multipiattaforma di ultima generazione (MS Edge, Chrome, Firefox e Safari)
- Progettato in conformità con il “Trial Master File Reference Model Version 3.2.0 02 Novembre 2020” proposto dalla Drug Information Association (DIA)
- Consente la gestione dei documenti della sperimentazione clinica: caricamento, revisione, approvazione o rifiuto da parte di utenti con ruoli specifici
- Personalizzazione del flusso di lavoro per ogni ruolo con autorizzazioni specifiche
- Gestisce il tracciamento completo del log di audit
Versione 1.0.2
- Correzione di un problema relativo alla visualizzazione assente o errata dei dati nella dashboard.
- Correzione di un problema legato ai centri e la loro assocazione ai pazienti e al tenant.
- Correzione di un problema relativo al tenant impiegato in fase di associazione al questionario.
Versione 1.0.1
- Correzione di problemi legati alla compilazione e traduzione di alcuni valori su questionario;
- Correzione di un problema legato all’associazione dei questionari verso il paziente;
- Correzione di bug legati ad ottimizzazioni.