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Datacapt 4.19 delivers a major step forward for RTSM (Randomization and Trial Supply Management), a completely redesigned eCRF experience, and several enhancements across EDC studies and Recruitment (Site CTMS) solutions.
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This version focuses on simplifying complex workflows for the randomization, improving data collection, and monitoring for sponsors, CROs, and sites.
š² RTSM - Randomization & Allocation
Weāve expanded our Randomization and Trial Supply Management (RTSM) to make study setup faster, safer, and fully integrated with your eCRF and inventory.
You can now activate Randomization and Allocation directly from the study settings.
Weāve moved the randomization configuration to a new Add-ons page called RTSM.
There, youāll find all the settings related to Randomization and Allocation.
All your previous randomizations have been automatically migrated to this new page and remain fully compatible.
The randomization settings have been completely redesigned to offer a clearer and more intuitive configuration experience.
New Randomization
Randomization setup is now protocol-driven and easier than ever.
Choose between Block, Dynamic minimization (PocockāSimon), or Import of pre-approved lists.
You can now manage:
Multiple randomization per study
Up to 25 treatment arms (including cross-over studies) with flexible weighting ratio
Stratification by site and up to 10 eCRF questions with a completely new item picker.
Blinding and scope control directly via permissions
Full audit trail for transparency and compliance
š” Why itās useful
Randomization is now managed in one place, no external tools, no manual tracking.
It saves setup time, keeps all stakeholders aligned, and ensures study balance automatically.
You can choose between Open Label (Single Blind) or Double Blind randomization when configuring your study.
In Open Label studies, treatment arms are visible in the eCRF, meaning investigators can see which treatment is assigned.
In Double Blind studies, treatment arms are hidden by default, ensuring that neither investigators nor participants know the assignment. Only users with specific unblinding permissions can view or manage treatment details.
The new item picker lets you browse all available questions, filter by visit, form and variable name, and choose the ones to use as stratification factors, for example: Baseline > Demographics >Gender.
Allocation
Weāve introduced a smarter way to manage kit allocation, now fully aligned with your randomization rules and site inventory.
Kit Types are the foundation, they define what is dispensed (e.g., vials, medications, or devices) and ensure each allocation follows your protocol logic.
Key updates include:
Map once, enforce everywhere: mappings flow automatically to eCRF and inventory
Site-aware allocation: only kits stored at the subjectās site are shown
FIFO logic: kits are dispensed in the order they were received
Automatic transition: from test to production lists at go-live
Real-time status sync: allocation and deallocation instantly update inventory
š” Why itās useful
Sites see only eligible kits, while sponsors and CROs keep full traceability from randomization to dispensation, all in one system.
š Learn more in the dedicated articles: RTSM - Randomization & Allocation
š§¾ EDC - New eCRF Records Design
Weāve completely redesigned the eCRF interface for data collection to make data entry, query management, and monitoring faster and clearer for all users.
Whatās new:
Left navigation tree: easily move between subjects, visits, and forms
Inline queries: view and resolve issues directly below each question
Persistent monitoring panel: SDV, review, lock, and audit trail always visible
Cleaner layout: improved spacing, visual hierarchy, and modernized question design
Quick participant switching: jump between records without leaving the form
š” Why itās useful
Everything you need to review, monitor, and verify data is now accessible without extra clicks, saving time for both site and data management teams.
š Explore the full walkthrough: New eCRF Records Design
š§¬ EDC - Study Management
Participant Statuses
Weāve introduced custom participant statuses to improve visibility and control across participant journeys.
Each status has a label, color, and optional Stop logic to pause communication (ePRO reminders, eConsent, and automations).
Statuses now appear in both the Subject Management page and the eCRF header, giving teams a clear overview of participant activity and state.
š” Why itās useful
Participant statuses let study teams represent real-world states like āScreening,ā āCompleted,ā or āWithdrawnā, making follow-up and reporting more reliable.
šŖ Need to customize your statuses?
Setup is handled by the Datacapt team. If youād like to define your own list, reach out to your Customer Success Manager who will guide you through the short setup form.
š Learn more in the detailed article: Participant Statuses
EDC - Required Email Field
You can now make the email field mandatory in study settings.
If a participantās email already exists in the system, youāll be prompted to link them from the Subject Database.
š” Why itās useful
Ensures every participant can receive ePRO or eConsent communications and prevents duplicate accounts.
EDC - Conditional Logic on Repeated Measures
You can now apply conditional display rules to Repeated measures/forms.
For example, display additional forms for concomitant treatments or adverse events only when relevant.
š” Why itās useful
Makes your eCRF more dynamic and reduces data-entry errors.
š§ CTMS - Recruitment Studies
New Participant Status Flexibility
You can now change a participantās status to any other by clicking āShow more statuses.ā
š” Why itās useful
Gives study teams more flexibility to update participant progress at any time.
CTMS - Add Participants from Recruitment Studies
Recruitment and EDC studies are now fully connected.
You can add participants directly from your recruitment study once they reach Qualified or Enrolled status.
š” Why itās useful
This saves time and avoids duplicates, participants move smoothly from screening to study inclusion.
ā ļø Requirements:
- Recruitment study status must be "recruiting"
- EDC study status must be "live"
- Link to the EDC study must be set-up in the recruitment study settings "EDC link"
CTMS - Restrict Who Can Apply
A new āWho can applyā option under study settings allows you to control recruitment access.
You can now choose between:
Allowing everyone to apply, or
Restricting to invited participants only
If someone not invited tries to apply, theyāll see an informational message but can still create an account for future invitations.
š” Why itās useful
Gives you greater control over recruitment flow and avoids unsolicited sign-ups.
The landing page now features a clear āEnrolling by invitationā badge, making it easier to identify studies with restricted enrollment.
š Bug Fixes
Weāve resolved several issues to improve stability and usability:
Fixed cases where password reset links didnāt work correctly
Updated Translation Access/Edit permission for non-Builder users
Fixed a behavior in Roles where permissions could toggle without saving
š¬ Learn More
š” Tip
If youād like a guided walkthrough of these new features, contact your Datacapt Customer Success Manager, we will be happy to show you whatās new in your workspace.
Release Package
š§ Minor Releases
Release 4.19.1 - Thursday 13th November 2025
š§© EDC - ePRO
Fixed an issue preventing ePRO records from being archived when selecting all pages.
Participants can no longer move forward (go next) without completing the āOtherā field in Radio or Checkbox questions.
Fixed an error when clicking āSee all recordsā in the ePRO Compliance with certain permissions.
Corrected a discrepancy where the questions counter could exceed the total number of questions in the ePRO Records list.
The confirmation popup for bulk resend now correctly shows how many invitations were sent.
Fixed the inability to paste multiple participant IDs when inviting via ePRO.
š² EDC - RTSM
Randomize and Allocate buttons now correctly remain disabled when the participant eCRF is locked.
Fixed an issue where imported randomization configurations could be removed when editing.
Added German translations for the RTSM module.
Added an error message when attempting to allocate with a configuration that has no kit type.
āļø Platform settings & Interface
Creating a new center now places the cursor in the Name field at the beginning of the page instead of Description at the end of the page.
When users select multiple records using the selection ticks, the corresponding rows are now clearly highlighted to indicate the active selection.
Fixed several issues related to browser window resizing.
The modal now highlights mandatory fields more clearly and automatically scrolls to any hidden required fields on smaller screen sizes.
š· Builder
The Edit and Duplicate Visit icons are now always visible, previously they appeared only when hovering over the visit name.
Release 4.19.2 - Wednesday 19th November 2025
š§© EDC - eCRF
We have fixed an issue where the eCRF answers were saved but not correctly displayed in specific conditions
š² EDC - RTSM
Fixed an issue where randomization details could appear in the network response when using the legacy Double Blinded Import workflow.
Corrected a bug where users without Unblind Access could still see the treatment arm in XLSX and CSV exports in double blind studies. Fix was applied to all exports.
Fixed an issue preventing exports to XLSX when the eCRF contained a calculation referencing Treatment arm ID.
Added support for the variable āTreatment_Arm_Nameā in automation rules. You can now use {TREATMENT_ARM_NAME} in subject title and mesage.
šØ CTMS - Recruitment
We fixed an issue in recruitment studies by clearly indicating the maximum limit of 20 pools, so users understand why they can no longer create new pools once this limit is reached.
āļø Platform Interface
We have fixed an issue where long participant status names could break the left menu layout in the new eCRF design. Layout is now stable.
Release 4.19.3 - Monday 24th November 2025
š§© EDC - eCRF
Fix bug and improved the accuracy of progress indicators in Repeated Measures: some answers were not counted, which could display an incorrect completion percentage.
Fixed an issue where table/matrix answers were not being saved correctly.
Corrected a behavior where pressing Enter in the new eCRF design caused the left menu to collapse.
Users can now manually type dates for all date/time fields after setting a custom date format in EDC settings.
š EDC - Audit Trails
The question filter now works for eCRF, ePRO and eConsent, instead of being limited to eCRF fields.
Resolved a display issue where some Audit Trails content became hidden after resizing the window. The view now adjusts properly even for small screens.
š Site CTMS - Calendar
Improved the display when two months overlap within the same week, ensuring the header remains clear and readable.
š· Global - Form Builder
Fixed a display issue in the Instructions editor (static content) where selecting a font color caused the page to scroll down unexpectedly.
Release 4.19.4 ā Wednesday 3rd December 2025
š§© EDC ā eCRF
We fixed an issue in the āSign eCRFā window where some forms appeared as needing corrections when, in fact, all visible questions were already completed.
We also resolved a problem affecting older studies where the legacy āRando Group IDā calculation could show an incorrect value.
š Site CTMS ā Recruitment
Participants applying to a recruitment study with an existing Datacapt account were sometimes redirected to the wrong page. The flow is now consistent and correct.
Invitation emails sent from the recruitment pool now include the "See Study" button, making navigation easier for participants.
š„ Platform ā Navigation & UI
Pagination no longer allows invalid values such as decimals.
š„ Platform ā Center Management
We fixed an error that occurred when creating a center with an address in the platform settings. New centers can now be added smoothly.