Dictionaries, uploaded once and available to every study of the tenant

Mappings, to declare which eCRF answers must be coded and against which dictionary

A coder workspace, with dictionary lookup and code assignment

A full audit trail on dictionaries, mappings and codes

Click Upload dictionary, name it, drop the package exactly as delivered by MedDRA and enter its password.

Version and language are read directly from the package.

The row shows Uploading, then Active, or Upload failed with the reason.

Several versions can be Active at once, which long studies need since MedDRA publishes about two releases a year.

Deprecate a version to stop it being offered in new mappings. Codes already assigned never change.

The package must be uploaded exactly as delivered. Unzipped, renamed or repackaged files fail processing.

One dictionary = one language × one version. Uniqueness is checked on type + version + language.

A dictionary used in at least one mapping cannot be deleted. Deprecate it instead.

A mapping is always one item to code, up to 10 supporting items, one dictionary.

Only free-text questions can be coded. Items inside repeated measures work; items inside a matrix cannot.

Supporting items can be of any type, from the same subsection. They give the coder context and are never coded.

Creation is retroactive: answers already filled are pulled into the coder's queue, not only new ones.

The item is deleted, or is no longer free text → Broken mapping (red). Collection stops and the verbatims collected so far and their codes are deleted.

The title, the variable or a supporting item changes → Modified mapping (yellow). Collection continues and codes are kept and a flag is displayed on the mapping.

The item is moved elsewhere → no flag, no impact.

One mapping per item to code and per dictionary. The same item can be mapped twice only against another dictionary.

Mappings cannot be edited, and deleting one deletes codes associated to verbatim, with no way back. A warning modal says so before confirmation.

One tab per mapping, alphabetical, with the Mappings tab last, and two views: Uncoded, the working queue, and All.

Columns are Verbatim, Code, Status, Subject, then one per supporting item. Verbatim and Code stay visible while scrolling sideways.

Clicking a verbatim opens a side panel with the full text and its supporting items, open by default.

From a verbatim. Clicking its text pre-fills the search bar, in the dictionary of its mapping, and stays editable.

From the dictionary. Find the term first, then pick a verbatim using that same dictionary.

The coder picks an LLT, displayed with its full path (LLT → PT → HLT → HLGT → SOC), so the choice can be checked before it is applied.

Search matches LLTs only, in contains mode, so partial words are enough: “ven recan proce” finds “Venous recanalization procedure”. Retired terms are excluded.

Terms on several branches show all their paths, blue for primary and white for secondary. The path selected is the path stored.

A verbatim can carry several codes, one per medical concept (“headache and vomiting” gets two). The status covers the whole set, and the verbatim stays one row.

The list reflects the state at load time. eCRF corrections appear after a reload or a tab switch.

Coding stops at Coded. Review, approval and export come in a next iteration.

Blinded studies are out of scope for now.

No filtering beyond the two views and no re-sorting. Use the search bar to narrow a long list.

Subjects Database centers: when a subject is added via an EDC study, their Subjects Database record now takes the study's center as the participant's global center.

Filters (Subject Database & Recruitment): after adding many filters, they could not be scrolled or added (Subject Database), and filter labels were partly cut off (Recruitment).

eConsent menu: some eConsent menu entries were renamed and reordered (e.g. "Dashboard" → "eConsent list") for clarity.

Randomization & permissions: a display issue and incorrect behaviour when configuring roles so that users (e.g. investigators) couldn’t see the randomization list without seeing the randomization settings.

eCRF review: sometimes a review was not showing in the visit view.

eCRF inclusion: form progress was not refreshed in real time (especially when answering quickly or switching sections).

CTMS payments: decimal amounts could not be entered in the payment settingd by study, the number was turned into an integer (e.g. 9.9 became 99).

CTMS payments: inconsistent behaviour when entering payment values (decimals handled differently in payment by visits / payment confirmation).

ePRO QR code: the QR link worked only for the first occurrence — after completing it, the participant could not complete the next ePRO occurrences.

ePRO dropdown: ePRO titles were not fully displayed in the selection dropdown, with no tooltip.

Translations (French, ePRO): a small wording inconsistency in the ePRO list menu.

Fix an issue when a radio-button question with an "Other" option was selected and not displayed to the user on the interface. The "Other" option is now displayed correctly.

Fix a bug, where the date/time format of an edited eCRF answer differed between the new-value and old-value fields in audit trails.

Section and subsection visibility permissions no longer apply inside the Builder. The user who restricts a section keeps access to it when editing the form.

Removing the source question of a Repeated Measures rule no longer breaks the conditional logic of the whole form. The remaining rules stay editable and can be replaced.

Duplicating a section or a subsection, or adding one from a template, now recalculates the conditional logic of the new section. The records shown were previously inherited from the original section.

Question order now holds after a page reload. Blocks could reappear in a different order than the one saved.

Updating a calculation created a duplicate entry, displayed out of order. A single entry is now recorded, in the right position.

The reason and comment entered for a Missing / Unknown answer are now recorded in the study audit trail.

Uploading a file to a file-upload question added a second entry a few seconds later that looked like a deletion, both in the Subject Database and in the eCRF. Only the upload is recorded now.

Reminders stop once the target date and time have passed, even when the questionnaire is still uncompleted. Participants no longer receive reminders for a survey they can no longer answer.

When an automation creates an ePRO for a participant with no email address, the ePRO is created but not sent, so a follow-up "ePRO sent" automation is no longer triggered.

A scheduled occurrence could be viewed and edited before sending but could not be opened from its QR code or its link. Both now open the occurrence.

Sending an eConsent to a subject with no first or last name returned a misleading message. The error now states that a first name and a last name are required.

Calculations are recalculated after importing data and exporting the list to refresh it. The imported values were kept as they were.

Returning to the participant list while it was sorted by the Availability column no longer displays an error message.

The Full Name column stays visible when the table displays only four variables.

An OPTIONS request on the public API returned a 500 error. It now returns Method Not Allowed, as expected.

❕ Platform - Draft & Suspended Studies
Study status is now much more visible while working inside a study. Draft and Suspended EDC studies now display a status chip and banner throughout the study, while Draft Recruitment Studies display the corresponding Draft indicators.

The banner is collapsed by default and can be expanded when additional information is needed. Live studies do not display a banner.

When adding participants to a Draft EDC study, a "Test subject" badge is also displayed to make it clear that participants created at this stage are test subjects.

In Recruitment Study settings, "Recruitment details" has also been renamed "Landing page" for greater clarity.

Center access is now clearer in Platform Settings > Centers. The action is displayed as Edit or View according to the user's permissions, and users with view-only access now see a read-only page.

Role changes now display both the previous role and the new role in the Study and Platform Audit Trails, providing clearer traceability of permission changes.

Fixed an issue that could generate an error when opening the Audit Trail for a Matrix question.

When an inclusion is opened from a Subject page, closing the eCRF now correctly returns to that Subject page rather than the Inclusion List.

In studies with more than 50 subjects, newly created subjects now open correctly after creation.

File removals are now recorded consistently in the Audit Trail. Previously, removing an uploaded file from an eCRF could be recorded as another upload.

Corrected discrepancies in eConsent exports where some information, including Randomization columns, could be missing depending on the selected records.

Resolved an issue where filtering a report by Center could return an empty report despite matching data being available.

Subject Database questions using conditional logic are now represented correctly in Recruitment exports instead of being displayed as ".hidden".

When a user is assigned as an administrator, access to all centers is now applied correctly.

Visit instructions are now displayed directly in the visit section of the Participant Dashboard, making important information available to participants in addition to confirmation and reminder emails.

Center codes can now contain up to 10 characters, increased from the previous 5-character limit.

When exporting a single inclusion, Queries, SDV and Missing Values are now limited to the selected inclusion instead of including information from all inclusions in the eCRF.

Repeated Measures answers hidden by conditional logic are no longer included when using the "Repeated Measures in separate sheet" export option.

Users with permission to manage Automations can now correctly select questions when creating or editing an automation, even without access to the Builder.

Corrected an issue where Role Assignment Restrictions could prevent authorized users from updating another user's center assignments, even when no change was made to their role.

All relevant Pre-screening Survey questions are now available when filtering participants within a Recruitment Study.

Recruitment Pool permissions have been corrected to ensure access follows the appropriate Recruitment Invitation permissions.

Subjects with only a phone number are now correctly included when creating ePRO records using "No invitation" and "All subjects".

Improved the performance of ePRO reminder processing.

ePRO links sent by SMS are now valid for 90 days instead of 30 days.

A transition mode in Global settings > Recruitment > Statuses: Manual only, On booked visit or On pre-qualified

A Pre-Qualified status between Interested and Qualified, with its own chip and quick status change in the participant list

A qualifying flag on one visit per schedule, next to the anchor visit, shown in the calendar, the bookings and the booked visits list

A per-study override in Study settings > Optional settings > Statuses, by turning off Use global settings

A Booking mode on each schedule, replacing the Published toggle: Manual only (only recruiters can book visits, from the Datacapt platform), Link only (participants can only book through a link shared by the recruiter) or Public (participants can book through any channel)

Share schedule(s): select several schedules, then create and share a link to one calendar merging their slots

A reworked booking calendar that shows the slots of several schedules at once and highlights directly the days with available slots, so participants can easily pick their preferred slot without browsing the calendar

The detail panel can now be resized by dragging its edge.

The verbatim panel no longer leaves empty space when a verbatim has no supporting items.

A code you've selected but not yet applied now stays visible if you navigate away and come back.

Two new columns show whether each participant has an email and a phone number (yes/no), to make managing email/SMS invitations easier.

The public API documentation has been cleaned up, with clearer descriptions for every endpoint.

New endpoints let you manage recruitment studies directly through the API: list and create studies, read the recruitment dashboard, get and update the landing page, and list a study's participants and payments.

Corrected an issue where the anchor visit could not be set up when creating a new schedule in a study already in Recruiting status.

Fixed an issue where scheduled ePRO invitations for participants without an email or phone number ignored their scheduled date and were sent out immediately instead.

When inviting participants to an ePRO by email, the selection list no longer shows participants who have no email address, so they can no longer be picked by mistake.

In Draft studies, all automation fields can now be edited. Before, some fields were locked even though the study was still in draft.

Fixed an issue where ePRO answers no longer appeared in reports. They weren't updated in the report and were missing from report exports. ePRO answers now display, refresh and export as expected.

When you change a slot's capacity in the calendar, the change is now kept after the schedule is edited. Before, these changes were reset every time the schedule was edited.

Participants can no longer book a visit through a schedule link once the recruitment study is Ended. The QR code, the invitation email and the participant workspace already blocked booking. Schedule links now do too.

Fixed an issue where some questions shown by conditional logic in the Subject Database questionnaire could stay hidden from the participant. This happened when:

Those new questions weren't displayed to the participant. They now appear as expected.

Fixed an issue that prevented opening another study from the study history in a participant's drawer. A blank page opened instead. It now works as expected.

A Statuses page in Global settings > EDC to create, rename, recolour, reorder and archive participant statuses. It is protected by a new Participant statuses permission: Edit to manage.

A default status, given automatically to new participants.

A Stops follow-up option: when a participant gets a status with this option (e.g. Screen Failure, Withdrawn), their ePRO sending, reminders and automations stop automatically.

A Participant status column in the inclusions list, shown as a coloured chip next to the participant ID, with a filter that lets you select several statuses, or No status.

A Participant status column in the eCRF study, single record, ePRO records and reports exports.

The notification emails sent around the eConsent counter-signature have a clearer subject and wording.

Fixed an issue where a subject's ePRO answers did not appear in reports when the subject also had an archived ePRO record left empty. The answers of the new record now appear as expected.

Fixed an issue where participants saw an "Oops, there is an error" message when opening the survey of a study in Recruiting status whose landing page is closed to participants. They now see a message explaining that recruitment is complete for now.

Fixed an issue where a participant added from the subject page, who did not have an account yet, landed on the login page when opening a schedule link. They are now taken to account creation, as expected.

The confirmation message shown after editing or deleting an event in the calendar now displays correctly.

In the center details, the phone preview now shows the saved instructions as soon as the page opens. Before, it stayed empty until you typed in the field.

In the participant portal, the eConsent task always said "complete your eConsent", whatever the participant actually had to do. The task now shows what is expected:

On platforms using eConsent without the Subject Database, participants had a task in their profile asking for their date of birth, even though it was not needed. This task no longer appears.

Fixed an issue where adding a center or editing a center code created an empty entry in the study audit trail, with no previous or new center code. These details are now recorded. This applies to changes made after the release. Earlier entries stay as they are.

Fixed an issue where PDF exports sometimes failed with a "Couldn't download, try again" error.

In the center details, the phone preview now shows colored text and pictures correctly.

Several French translations have been corrected.

An MCP server that connects your AI assistant to Datacapt. It works with Claude, ChatGPT, Cursor, VS Code and any other MCP-compatible assistant.

With 52 tools, the assistant can read and build your eCRF, ePRO, eConsent and recruitment campaigns. It can also read your monitoring figures and the audit trail.

A new MCP page in your user settings, with the server URL, your personal MCP key and the list of connected apps. Each app can be removed with Disconnect.

Sign-in with OAuth: the assistant opens a Datacapt page where you choose to give it read access or read and change access.

An MCP badge next to the user name in the study and platform audit trails, so you can see which changes were made through an assistant.

4 coding statuses, shown as colored badges in the Coder table and in the coding panel: Uncoded (gray), Coded (blue), Approved (green) and Rejected (orange)

Approve, Reject and Clear code buttons in the coding panel, shown depending on the current status

A new Medical coding - Review permission for the people allowed to approve or reject codes

Coded by and Approved by are recorded separately, each with its date

If a verbatim is edited in the eCRF after it was coded, it goes back to Uncoded and the previous code stays visible in gray (e.g. Previous: Headache)

Every status change is recorded in the audit trail, and the status counters in the Coder tab update right away

Checkboxes in the Coder table, and a selection bar showing how many rows are selected, with Search code / Apply code(s), Approve, Reject and Clear code

Two ways to apply a code: select the rows then search for the code, or pick the code first then select the rows. An interpretation entered with the code is added to every selected row.

Only the actions that work for all selected rows are available

A confirmation window appears before approving, rejecting, clearing, or replacing existing codes

An Export button at the top of the Medical coding page, where you choose the mapping(s) to export

A CSV file with the center, subject, visit, form and item, the verbatim, its coding status, the full MedDRA hierarchy (LLT to SOC, including the primary SOC), the interpretation, and who coded and reviewed it

One row per code: a verbatim with several codes appears on several rows, numbered with a Code index. An uncoded verbatim appears on one row with empty code columns.

A new Medical coding - Export permission

Each export is recorded in the audit trail, with the names of the exported mappings

The Coder table can now be filtered by code, status and subject, searched by verbatim, and sorted by code. Filters apply to the whole list, not only to the page you are on, and are reset when you switch mapping tab.

Fixed an issue where archived ePRO records could not be exported when the ePRO form was Published. They can now be exported.

Fixed an issue where, when the last question had a data validation leading to exclusion, refreshing the page skipped the exclusion and the ePRO was sent anyway. The exclusion now applies after a refresh.

Archived centers can no longer be selected in the filters. Before, filtering by an archived center returned subjects whose center was no longer displayed.

When deleting an event, the warning said that booked visits would be deleted, while they are actually cancelled and kept in the Booked visits list. The message now matches what happens.

Fixed an issue where deleted users still appeared in the study user list on some studies.

In a LIVE study with at least one participant, center codes can no longer be added or changed. Before, this was still possible.

Fixed an issue where a user allowed to edit users, but without the Invite to all studies / projects permission, could not change some team members' roles (error 21004 when saving).