Release on Tuesday, March 4th, 2024 between 10:00 pm and 11:30 pm UTC.
EDC - New Features
Global
Center - You can now manage detailed center information with the following fields:
Center Name and Abbreviation
Full Address: New field using Google API/Library. Users can search for and select an address, storing normalized data in separate fields.
Email Contact (Site Email): Main email contact for the center.
Phone Number (Site Phone Number): Main phone contact for the center.
Map Display: Coordinates are stored to display the center's location with a pin for the participant
Instructions (Site Instructions): Rich text field allowing up to 5,000 characters with links, lists, and formatting for the participants.
Rich text editor - A new, modern rich text editor has been added, offering enhanced customization. You can now add colors, images, titles, lists, and much more to create rich and visually appealing content.
eCRF
Bulk Signature - Added the ability to apply bulk signatures from the inclusions list, allowing users to sign multiple documents at once for improved efficiency.
eConsent
Versioning: Track and manage multiple versions of eConsent forms, ensuring clarity and compliance with version history for updates or modifications. This also allows you to create multiple documents that participants can sign.
eConsent Form List: View all eConsent forms in a centralized list, with details like eConsent name, version, version date, status and centers for quick access and management.
Invitation Modal: Send eConsent invitations with a user-friendly modal. Select sending method (Email, SMS or QR-Code), eConsent version, select participants and customize messages.
eConsent Status: Monitor the status of eConsents (Draft, Published, Archived) with real-time updates for easy tracking and management.
Dashboard: Get a comprehensive overview of eConsent activity, including statuses, and version summaries in a user-friendly interface.
Export: Export eConsent meta data in various formats for reporting, analysis, or record-keeping while ensuring data integrity and compliance.
ePRO
XLSX and CSV reports - We have introduced a powerful new Global Export feature, designed to provide advanced reporting capabilities and deeper insights into your data. This feature includes several new comprehensive reports, tailored to help you manage and analyze your study data effectively.
Here are the key reports included:
ePRO Forms List Report
Provides a complete list of all ePRO (electronic Patient-Reported Outcomes) forms associated with your study. Displays the total number of records and progress for each form. This offers a high-level overview of the forms' distribution and activity for better study management.ePRO Records List Report:
Displays all existing survey records for a specific study in detail. Includes each record's individual status, such as whether it is completed, pending, or partially completed. Allows real-time tracking of each survey's progress, including starting time and completion time, enabling users to identify bottlenecks, monitor delays, and address incomplete responses efficiently.
ePRO Compliance Report
Calculates participant compliance rates based on scheduled, completed, and uncompleted surveys. Helps you monitor participant adherence in real time, ensuring you stay informed about overall study compliance. This offers valuable insights to identify participants who may need follow-ups or reminders, enhancing data quality and consistency.
This new Global Export feature consolidates all these reports into a single, easy-to-access location, enabling you to export data in a structured and organized format. With this export, you can streamline study oversight, improve participant compliance monitoring, and gain actionable insights to optimize your research processes.
Copyright - Added the ability to include copyright information from licensed ePRO content. The copyright is now displayed in the footer of each question.
Bulk actions - We have introduced a new feature that allows users to perform bulk actions directly on the ePRO records list. This enhancement streamlines the management of survey records by enabling users to select multiple surveys at once and take the following actions:
Resend Surveys: Quickly resend selected surveys to participants who may have missed or not completed them. Ideal for ensuring timely survey completion and improving response rates.
Archive Surveys: Easily archive multiple surveys for better organization and to declutter your active records list. Archived surveys remain accessible for future reference or reporting.
Export Surveys: Select and export multiple survey records in one action for detailed analysis or reporting purposes. Exported data includes key details such as participant responses, survey statuses, and timestamps.
Study Add-ons
Automations with calculations - You can now use calculation questions to trigger automation from eCRF, ePRO, and eConsent. Multiple operators can be used to create your automations and streamline your workflow.
Automations with system variable - You can now use system variables such as Center and Randomization Group to trigger automation.
CTMS - New Features
Patient Database Management
New Filters - We have added new filters for the patient database attributes to provide a better filter on your database. You now have access to:
Filter by date and text
Filter by Studies and Recruitment Studies
We added new operators: Empty/Not Empty
Bulk Delete - We have added a new Bulk Delete feature, allowing users to efficiently manage and remove multiple patients from the database in a single action. This feature streamlines patient management and provides the following capabilities:
Select Multiple Patients: Users can select multiple patient records from the patient database list for deletion, saving time and effort compared to deleting records individually.
Confirmation Prompt: To prevent accidental deletions, a confirmation prompt ensures that users review and confirm their selection before proceeding.
Compliance and Security: The bulk delete process adheres to data compliance and security guidelines, ensuring that deleted data is handled responsibly and irreversibly.
Overwrite import - We have introduced a new overwrite Import feature, designed to streamline the process of updating or replacing existing data in the database for patient attributes. This feature allows users to import new datasets while overwriting existing records.
Users can now upload a data file (CSV, Excel) and choose the "Overwrite" option during the import process. The system intelligently matches records based on unique identifiers (Datacapt ID) and updates the existing data with the new information.
Only the fields provided in the new import file will overwrite the corresponding fields in the database. Fields not included in the import file remain unchanged. All overwrite actions are logged, providing a detailed audit trail for tracking changes to the database.
Recruitment Study
New table filters - We have introduced new filters in the system to improve data management and streamline the user experience. These filters allow users to quickly narrow down and analyze data based on specific criteria.
The new filters include:Center Filter : Users can filter records or participants based on the center they are associated with. This is particularly helpful for multi-center studies, enabling users to focus on data from a specific location.
Pools Filter: Allows filtering by participant pools or groupings, making it easier to manage and analyze subsets of participants. Ideal for studies that involve segmented groups or cohorts.
Pre-Screening Survey Question Filter: Users can filter participants based on their responses to specific questions in the pre-screening survey. This functionality helps identify participants who meet or do not meet certain criteria, aiding in targeted analyses or recruitment decisions.
Delete participant - We have added a feature that allows users to delete participants from the participant list when necessary.
Disqualify reason - We now display the disqualification reason (Not eligible or Not available). This feature provides better clarity and tracking for disqualified participants.
General
Performance Improvement - We improved the overall performance for the builders and the eCRF answers when doing data entry for large study.
Error page - We have implemented a new Error Page to replace the blank white screen previously shown when an error occurred. This enhancement ensures a better user experience and provides actionable information.
Account activation - We have resolved an issue where account activation emails were sent, and the account was flagged as activated but it was not activated yet.
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Service Pack - Improvements
V4.17.1 - 5 March 2025
ePRO Sending in eCRF - We fixed an issue that prevented users from sending or resending an ePRO from the eCRF. With this fix, users can now send or resend ePROs directly from the eCRF without any interruptions.
V4.17.2 - 6 March 2025
Big File Upload (>500Mb) (Global) - Resolved an issue where uploading files larger than 500GB would fail unexpectedly. With this fix, users can now upload files exceeding 500GB reliably and without disruptions.
eConsent Signing with SSO (eConsent) - Fixed an issue that prevented users from signing eConsent forms using the SSO method. Signing eConsent with SSO now works seamlessly.
Patient Database Issue (CTMS - Database) - Fixed an issue where the profile in the patient database was not updated with the correct data for the selected subject, resulting in data being displayed for the wrong subject.
V4.17.3 - 10 March 2025
Pool SMS Campaign (Recruitment) - We resolved an issue that prevented SMS campaigns from being sent.
V4.17.4 - 16th March 2025
eCRF Performance improvements - We have migrated all GET /answers endpoints to utilize our second RDS Database instead of the primary RDS database. This change improves system performance and reliability.
Question saving (eCRF) - We have enhanced the eCRF interface to show the saving of data in real time, allowing you to visually track when information is being saved to the system. Additionally, we've implemented a safeguard that temporarily locks the "Next" action button while data is actively saving. This prevents navigation to the next form until the current data is completely saved, eliminating potential data saving issues that could occur when moving between forms too quickly.
We have also introduced a queuing system for data saving, ensuring that all changes are properly processed in sequence without conflicts, even when multiple updates are made in rapid succession.Builder loading (eCRF) - We've resolved an issue affecting the Builder that were causing reloading problems, loading failures.
V4.17.5 - 21 March 2025
Date Entry Error Message (EDC) - Fixed an issue where no clear error message was displayed if a date did not follow the exact required format from study settings. Users will now see a clear and actionable error message when entering an incorrectly formatted date.
Slider Questions Tick Value (EDC) - Fixed an issue in the where some tick values were not displayed in Slider questions. The slider now correctly shows all tick values.
Permissions Descriptions - Improved French translations and refined the English copy in the permissions descriptions under the Roles section to ensure clarity and consistency.
eConsent Date Formats - Fixed an issue in eConsent where different date formats were displayed simultaneously on the Dashboard. Dates are now consistently formatted across the Dashboard for better clarity and uniformity.
ePRO Export - Fixed an issue introduced in update 4.17.0 where the "Export ALL" functionality in ePRO was not working correctly due to conflicts with center access.
V4.17.6 - 25th March 2025
Forms Progress Label (eCRF) - Changed the status label from "Fulfilled" to "Completed" in form's progress for improved clarity and consistency across the platform.
Progress Calculations (Global) - Implemented the first phase of improved progress calculations to provide more efficient progress calculations.
eConsult Enhancements (eConsult) - Resolved multiple issues with the video televisit feature:
Fixed incorrect notification text showing "Invitation email sent to the Subject" after sending an SMS
Corrected picture-in-picture positioning and fixed non-functioning repositioning controls
Fixed meeting timer that was incorrectly displaying 00:00:00
Prevented subjects from accidentally rejoining ended calls by refreshing the page
Improved various error messages and removed unnecessary notifications
Participant Dashboard Improvements - Fixed an issue where rejected eConsent forms were incorrectly appearing in the "To do" tab instead of the "Completed" tab.
ePRO Forms (ePRO) - Fixed a bug where the red indicator for required empty fields would disappear prematurely before the answer was provided.
Alerts - Improved error messaging when entering Abbreviation codes longer than 10 characters and for creation of the automations with names exceeding 50 characters.
V4.17.7 - 31th March 2025
UI Improvements (Global) - Fixed design inconsistency with the up and down arrows for number questions.
Form Builder (Global) - Fixed an issue where the value "0" for the minimum number allowed was incorrectly treated as NULL and would disappear.
Improvements (Patient Management) - We addressed multiple issues:
Corrected the wrong icon displayed for "Account creation" in the quick view
Fixed filters not properly updating KPI
Visit Name (Recruitment - Booked Visit List) - Fixed an issue where the full name of Events was not visible in the visits column.
eCRF Records Signature (eCRF) - Fixed an error that occurred when trying to sign more than one page of inclusions simultaneously as a User with SSO.
Form Builder (eCRF) - Now allowing the use of underscore character "_" for section prefix/suffix for improved flexibility in form design.
Monitoring Tools (EDC) - Fixed an issue where the search functionality in filters was not working correctly for the monitoring pages.
Improvements (eConsent) - Made several improvements:
Added a missing "Back" button in the "Structure" part of the builder
Updated outdated footer in the email preview when sending eConsent invitation
Removed the PDF export option in the eConsent dashboard to better handle permissions
Subject Online Account (Participant Account) - Fixed an issue that made it impossible to modify their email address.
Survey Display (ePRO) - Fixed broken layout of rating questions on small screens.
V4.17.7 - 04th April 2025
ePRO SMS invitation (API) - Fixed an issue where the short code sent by SMS was redirecting to a 404 page.
V4.17.8 - 08th April 2025
CSV exports (Global) - We improved CSV exports to handle open text questions with line breaks that were breaking document formatting.
Data Visualization (EDC - Reports) - Fixed an issue where the same color was used for different values on a single chart. We also improved tables layouts when many date questions are added to prevent tiny, unusable columns
Logo in PDF (EDC) - Fixed logo customization not working properly in PDF exports.
Randomization (EDC - eCRF) - Fixed an issue where changing a study to LIVE status was not generating new strata or resetting the stratum in specific configuration.
Languages & Translations (EDC) - We added support for Brazilian Portuguese in EDC translation and we fixed translation errors in Portuguese. We also corrected French translation for "Payment" in the Recruitment solution.
Profile Picture (Patient Management) - Fixed an issue where subject pictures would incorrectly appear for subjects without photos when navigating with Previous/Next buttons in quick view.
Payments (CTMS) - Fixed incorrect error message when confirming an already confirmed payment (processing status).
Participant Account Improvements:
Fixed an issue where rejected eConsents remained in the "To do" tab instead of moving to appropriate status.
Fixed misalignment of information in "Participation details" on public recruitment pages.
Fixed 404 errors when opening login links from "Your Account Is Scheduled for Deletion" emails
Corrected links that were leading to /en/ language path when the subject's selected language was different
User Interface - Fixed display issue where long email addresses didn't fit in the information field. We Resolved bugs in the Recruitment settings page associated with smaller screen sizes. We corrected the rich text editor behavior where clicking any icon would move the cursor to the beginning
V4.17.9 - 16th April 2025
Improvements (eCRF):
Fixed an issue where only one uploaded file was visible when users uploaded multiple files at once
Resolved a bug where the dash (-) character was deleted from number fields unless quickly followed by a number
Fixed the number question issue in the builder where setting decimal limit to 0 was not properly enforce
Fixed an issue where users couldn't close a question or a repeated measure if it was opened as a result of a search in the builder
Fixed an issue where users were unnecessarily prompted to enter free text Subject ID when the Subject already had an ID assigned
Automations - Fixed an issue where an "Email is incorrect" error appeared when users typed part of an email and then pressed Enter
eConsent Enhancements:
Fixed records that were incorrectly stuck at "needs counter signature" status when they should be showing as "signed"
Resolved duplicate events appearing in eConsent Audit Trail for improved tracking accuracy
Date/Time Questions (EDC) - Improved the "Now" button functionality to correctly use the time zone time instead of system time for more accurate timestamps
Audit Trails (EDC):
Corrected labeling where "User role" was incorrectly called "Invited user role" and missing role information
Added missing file names in "Details" section of Audit trails related to Document actions (Created/Downloaded/Deleted)
User Interface:
Fixed display issues with long email addresses not fitting in information fields on Safari browser
Corrected the positioning of the "No Activity" image in Subject Database, which was shifted left instead of properly centered.
Public Portal - Fixed placeholder text "{e-mail}" incorrectly appearing instead of the participant's actual email address on the "Recover your password" page
V4.17.10 - 24th April 2025
Source Data Verification (eCRF) - Fixed an issue where forms weren't properly marked as SDV-ed even when all displayed fields were verified.
ePRO Integration (eCRF) - Improved clarity of error messages when attempting to invite a subject to ePRO via eCRF when the subject is already invited and occurrences are disabled.
Date/time picker (Global) - Corrected date/time item and calendar picker components to properly use the configured time zone settings instead of system date for consistent global usage.
Upload file deletion (Global) - Added confirmation tooltip before deleting uploaded files to prevent accidental deletions.
User Interface Improvements:
Enhanced the rich text editor to maintain proper cursor position after hovering over header icons.
Fixed layout issues in the Automation when using "Question" displaying long field content.
Corrected German translation for the word "SUBJECTS" to ensure language consistency throughout the platform.