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Version 1.355.4 - 14th of October 2026

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New Features

  • AI-Suggested Description & Instruction Text: The AI Pathway Builder can now propose Description and Instruction text for a question group and for each question inside it. Ask the AI to improve or write the descriptions on a group and you get the usual ghost suggestion card, with the proposed text shown under each question and one for the group itself. Accepting writes the text into the pathway and records it in the audit trail. Any description or instruction you leave out of the request stays as it is, so asking the AI for an unrelated change never wipes text someone wrote by hand.
  • Source Data Capture (Beta): Site teams can now upload source documents — lab reports, radiology PDFs, scanned notes, screenshots — directly in a participant’s pathway and let the AI suggest values for the matching CRF fields. Suggestions stream in below their fields as each document is read, showing the suggested value, a confidence tag, the verbatim source quote, and the source file name; you apply or dismiss each one individually, and nothing is ever written automatically. Applied values go through the same validation and conditional logic as hand-typed entries, and every apply or dismiss decision is recorded in the audit trail together with the document excerpt it came from. Suggestions are visible only to the user who ran the extraction. For fields marked as sensitive, the suggested value, source quote, and reasoning stay encrypted with the site’s key in the suggestion and in its audit entry, and are decrypted only for display. Uploaded documents are read once and discarded — only file names are kept in the extraction history, so rename files containing patient-identifying information before uploading. Extractions support up to 12 files and 9 MB per batch, can be stopped mid-run, and keep running if you navigate away. Source Data Capture is off by default and is enabled per study under Study > Setup > Site Settings. Active studies must be in amendment to change the setting, and every change is recorded in the study audit trail. See Source Data Capture.
  • Randomization for Controlled Trials: Studies can now allocate participants to study arms using a pre-generated permuted-block schedule instead of manual arm selection. Configure block size, per-site enrollment targets, and an over-enrollment allowance on the study setup page. Approving the first CRF version locks the configuration; the study team then generates the randomization list manually, and the study cannot be started until the list exists. Sites draw the next block on demand as they enroll, keeping arms balanced at every completed block boundary. Enrollment is blocked with a clear error when no free block or slot is available for that site, and the study team gets an early low-capacity warning to extend the list before sites are affected. Randomized participants show a Randomized tag and their arm assignment is included in CRF PDF exports. See Randomization.
  • Randomization Log Viewer: The randomization log has been upgraded to a full-featured table with new Randomized by, Block index, and Position in block columns alongside the participant, site, arm, and timestamp. You can sort, filter, and group the log by any column and export it as a CSV file. Authorized study team members also see a capacity summary of total, allocated, and remaining blocks and slots above the log, making it easy to tell when the list needs extending. Every view of the study-wide or site-scoped log is recorded in the audit trail. See Randomization log.
  • Randomization Log PDF Export: The randomization log can be downloaded as a PDF report for archiving and audit purposes. The report includes the randomization settings, the current list status (total, allocated, and remaining blocks and slots), and the full allocations log. Exports from a site page are scoped to that site.
  • Extended Thinking in the AI Agent: You can now turn on extended thinking from the model selection header in the AI Agent side panel. The model reasons through your question before answering, and its thinking appears above the answer in a collapsed panel you can expand. Extended thinking is off by default because it takes more time and tokens. It works with Claude Sonnet 4.6, Claude Opus 4.8, and Gemini 3.5 Flash. The model decides whether a question needs thinking, so simple questions may return no thinking at all.
  • Signature Meaning for CRF Signatures: CRF signatures now record their meaning, Investigator Approval, as required by 21 CFR 11.50(a). The sign dialog shows the meaning and its definition before you enter your password. The signed record, the audit trail entry, and the CRF PDF all show the stored meaning. Participant CSV exports (all participants and shadow) gain Signed By, Signature Date, and Signature Meaning columns. Existing signatures are not migrated and keep showing Author’s Signature. See CRF Signing.
  • Multiple Data Validation Rules per Question: Study designers can now attach several independent plausibility and edit checks to a single question instead of being limited to one rule. Each rule keeps its own action (flag, warn, or reject-if), condition, and message, so you can, for example, flag values outside an expected range and reject values outside a hard limit on the same field.

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Stability Enhancements and User Experience Improvements

  • Correct Wording for Data Validation Conditions: Fixed an issue in the data validation rule editor and viewer where the UI suggested the condition had to be not met for the validation error to trigger. The wording now correctly reflects that the error triggers when the condition is met, matching how the rules actually evaluate at data entry time.
  • “Indexed” Status for Text Documents: Study documents written in the built-in text editor now show the same indexing status tag as uploaded PDFs. Because text documents need no background extraction, they show Indexed as soon as they are saved, making it clear at a glance that the AI Agent can reference them. Existing text documents have been updated to display the tag as well.
  • Accurate “Last Updated” Dates on the Participant Pathway Dashboard: Fixed an issue where the Participant Pathway dashboard only showed the date a CRF version itself was last changed (such as its creation or a label edit), ignoring changes to its content. The dashboard now shows the most recent update to either the version or its content, so adding or editing a question is reflected immediately. Comments do not affect this timestamp. Versions within each status group are now also sorted by this same date.
  • Return to the Participant List in One Step: The study and site links in the breadcrumb of a participant record and of the participant lists now open the Participants tab of the study or site page, so you get back to the participant overview in one step instead of landing on the first tab.
  • Organization Switcher Shows Every Organization: Fixed an issue where the organization switcher cut off the list for users who belong to many organizations. The list now scrolls inside the menu, so every organization stays reachable.
  • Security Hardening: Updated third-party libraries to versions that include recent security fixes.
  • Source Data Capture Flags Differing Answers: Source Data Capture now suggests a value for a field that already has an answer when the source document shows a different value. Before, answered fields were usually skipped, so a wrongly typed value was never flagged. Carelane compares each found value with the current answer itself and shows the suggestion with the Overwrites tag and the old value struck through. The AI never receives the answers in the CRF. Fixed an issue where the Overwrites tag appeared for coded and quantity answers even when the suggested value matched the current answer.
  • Source Data Capture Supports Multiple-Choice Questions: Source Data Capture now suggests every matching option for a multiple-choice question. Before, a suggestion showed only the first option the AI found, and applying it removed all other selected options. The suggestion now lists all matching options, and applying it saves all of them.

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Version 1.342.0 - 6th of August 2026

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New Features

  • AI Pathway Builder Available Everywhere in a Study: The AI Pathway Builder no longer requires you to open a specific CRF version before you can ask for edits. The tools are now gated on the Study AI Prompts permission alone, and the AI auto-selects the only draft CRF version if there is one — or asks you which draft to edit when there are several. Combined with piecewise reads of the pathway outline and individual question groups, the assistant can now navigate and refactor mature multi-hundred-question pathways without truncation.
  • Stop Button for the AI Agent: While a response is streaming in the AI Agent side panel, the send button becomes a stop control. Clicking it cancels the request and keeps the partial response and any tool output produced so far, so you can iterate on it without starting over. Aborted requests are treated as a clean user cancel rather than an error.
  • Streamlined Organization Creation & Type Selection: The organization creation wizard has been redesigned around a card-grid picker for organization type, covering Pharmaceutical, Biotech, CRO, Hospital, Academic / Research Institute, Medical Device, and Other. A type is now required to create an organization; selecting Other requires a short free-text label so classification stays consistent across reporting and audit trails. Administrators can update the type at any time from Settings > General, and each change is logged in the organization audit trail. New workspaces are automatically provisioned with the Free license.

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Stability Enhancements and User Experience Improvements

  • Longer AI Multi-Step Runs: The AI Agent’s per-response tool-step budget has been raised from 10 to 75, so multi-step tasks like reading a large pathway and then rewriting it complete in a single turn. If the AI still runs out of steps, it stops with a message asking you to send a short follow-up (for example, “continue”) to pick up where it left off.
  • Organization Creation Restricted to the Carelane Team: Organization creation is now handled by the Carelane team to prevent orphaned or duplicate tenants that were difficult to trace in support. The Add Organization entry no longer appears in the organization switcher for customer accounts, and the underlying endpoint rejects non-Carelane callers so the restriction cannot be bypassed from outside the UI. Customers who sign in without belonging to an organization now see a screen directing them to their administrator or support@carelane.io instead of a creation wizard they cannot complete. To request a new organization, contact Carelane support with the organization name, type, and intended administrator.
  • Private Workspace Removed: The “private workspace” option has been removed from onboarding. Every new workspace is now a standard organization, so single-user teams get the same collaboration, invitation, and role controls without a separate flow.
  • Participant Self-Registration Removed: Participants can no longer register themselves through a public portal. Onboarding is uncharacteristic for an EDC when it happens outside the study and site workflows, so the Participant Registration Portal setting, the per-site registration PIN and its public registration page have all been removed. The Public Participant Information editor is removed along with them, as the registration page was the only place its content was ever shown — the Public Info Hub study information page is unaffected. Participant enrolment continues unchanged through the study and site teams, and study arms are no longer restricted by a registration portal.
  • Public Templates Removed: Removed the option to share templates publicly across organizations. Questionnaire, Participant Pathway, and Site Task templates are now strictly private to their owning organizational unit while remaining fully accessible to your team.
  • Simpler Organization Creation: The organization description field has been dropped from the initial creation step to keep the wizard focused. You can still add a description (and logo and branding) later from Settings > General.
  • Accurate Participant Status Displays: Resolved an issue where rapid-fire updates (such as verifying several form sections in quick succession) could cause the participant list and dashboard to display an outdated status tag compared to the actual participant page. The system now always double-checks the live record to ensure your dashboard and list views stay perfectly accurate.
  • Optimized Public Page Loading: Enhanced the loading experience across all public-facing study and registration pages to eliminate blank delays. The system now displays immediate loading indicators to reassure visitors that the page is on its way.
  • AI Assistant Reliability Improvements: Fixed an issue where the AI assistant would occasionally freeze or crash when reviewing participant data. This occurred because the assistant would mistakenly load massive public study documents - including large attachments - into its memory. The system now ensures the AI only references this information when strictly relevant and automatically filters out heavy file data to maintain fast, stable performance.
  • Site-Role Redirection Fix: Fixed an issue where users with dual roles (both sponsor and site staff) were incorrectly redirected to the global study participant list after archiving a participant. The system now preserves your site-level view, returning you directly to your specific site’s participant list so you can continue your site workflow without interruption.

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Version 1.336.0 - 6th of July 2026

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New Features

  • “Queries Responded” Tracking & Filters for Site Teams: Improved the query workflow for site staff by distinguishing between open queries requiring site action and those already answered. Site members now have access to a dedicated “Queries Responded” dashboard card, participant tags, and list filters to easily isolate cases awaiting sponsor review. Additionally, the daily pending query email notifications have been updated to exclude these answered queries, eliminating unnecessary automated reminders.
  • Dropdown Controls for Multiple-Choice Questions: Extended the dropdown selection mode to multiple-choice questions, so designers can now toggle the display of both single-choice and multiple-choice questions between the standard list view and a compact dropdown format. Dropdown values can be cleared by deselecting them, and any change to a question’s display control is captured in the questionnaire audit trail.

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Stability Enhancements and User Experience Improvements

  • Accurate Participant Record & Query Statuses: Fixed a display discrepancy where the participant list and main dashboard could fall out of sync with the actual data shown on the participant’s details page. This was caused by background tasks processing rapid updates out of order, which occasionally left the duplicated display data in an incorrect state (e.g., a participant still appearing as having open queries on the dashboard after they were resolved). Statuses on the listing pages now update reliably, ensuring consistency across all views.
    • Note: The underlying source data and the participant details page itself were never impacted by this issue.
  • Form Builder Drag-and-Drop Stability Fix: Fixed a page crash that occurred when dragging top-level pathway sections in the form editor.

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Version 1.334.0 - 22nd of June 2026

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New Features

  • Dropdown Controls for Single-Choice Questions: Added a dropdown selection mode as an alternative layout for single-choice questions to better accommodate long option lists (like countries or taxonomies). In the study model editor, designers can now toggle a question’s display between the standard list view and a compact dropdown format.

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Stability Enhancements and User Experience Improvements

  • Extended MFA Backend Enforcement: Following our recent release of organization-wide MFA enforcement, we have extended this security model to protect all sensitive backend operations across the platform. This update introduces strict security gates that block non-MFA sessions from executing critical actions - such as data exports, user invitations, and CRF schema changes - ensuring end-to-end data isolation without changing the experience for users with an active MFA session.
  • Unified Study Arms & Lifecycle Guardrails: Simplified study design by moving study arm configurations out of individual CRF versions and into a single, shared list at the study level. To protect this unified data, the system now restricts changes based on the status of your CRF versions. While draft configurations remain fully editable, study arms referenced by testing versions cannot be changed or removed. Once any CRF version is approved, the entire study arm configuration is locked completely to eliminate the risk of accidental design alterations during active data entry.
  • Consolidated Multi-Version Reporting: Optimized participant data exports to seamlessly group unchanged clinical fields across different CRF versions. Participants on different CRF versions will now have their unchanged data fields properly aligned into the same export columns, preventing column duplication during study data analysis. See Export Types.
    • Caution: Because this updates the CSV header structure, refreshing data within existing reports will disrupt current field-level filters. Teams will need to re-verify and adjust their filters to match the new unified column names

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Version 1.330.0 - 8th of June 2026

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New Features

  • Organization-Wide MFA Enforcement: Organization administrators can now require all team members to use Multi-Factor Authentication to access Carelane. When enabled, users without MFA will be prompted to complete a quick setup before they can continue using the platform, and manual deactivation is disabled to keep accounts secure. For team members who work across multiple organizations, MFA will remain active as long as at least one of their organizations requires it.
  • Advanced Data Validation & Edit Checks: Study designers can now build complex rules to verify the plausibility and consistency of clinical data during entry, going beyond simple completion checks. The system supports soft warnings and hard limits for both single-field values and multi-form logic. When filling out or previewing a CRF, these rules run in real time - triggering inline alerts or preventing invalid saves to eliminate human error at the source.
  • Human-Readable CRF Record Exports: Introduced a human-readable PDF export for individual CRF records, designed for auditing and compliance tracking. The system generates a complete, standalone PDF document containing all clinical data fields alongside their corresponding signature histories and transition audit events. This ensures that accurate record copies can be easily saved, archived, and reviewed entirely outside of the platform.
  • AI-Powered Study Analyses (Beta): Launched a modern data-analysis preview tool featuring an integrated, in-browser Python runtime. This environment allows study teams and our AI assistant to instantly collaborate on generating custom data plots, trend metrics, and summaries from live participant data - maximizing analytical flexibility while keeping execution completely secure and sandboxed.

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Stability Enhancements and User Experience Improvements

  • Organization Settings & Navigation Fix: Resolved an issue where editing organization details would cause the UI to flicker, fail to save changes, and freeze the screen, blocking users from navigating to other pages.
  • Next-Gen AI Model Upgrades: Upgraded our underlying AI models to Gemini 3.5 Flash and Claude Opus 4.8 to ensure optimal performance and speed across the platform. Gemini 3.5 Flash now completely handles PDF document extraction during study setup and chat context loading, replacing the legacy Gemini 2.5 models to provide more accurate structural parsing.
  • “Ready for Review” Filters & Shortcuts: Added a “No Queries in Progress” option to the participant list filter, alongside a “Ready for Review” shortcut card on the study dashboard. This allows monitoring and review teams to immediately surface cases that are fully completed by site staff but still require data verification.

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Version 1.324.0 - 29th of April 2026

This release bundles every improvement merged since version 1.302.0 into a single, unified update — with a focus on Site Tasks, a redesigned AI experience with the new AI Pathway Builder, and a safer, more visible enrolment workflow for sites.

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New Features

  • Site Tasks: A brand-new task management system for study-to-site workflows. Study teams create reusable task definitions (title, description, tags, SLA in days, required documents) and bulk-assign them to one or many sites in a single operation. Each assigned task has its own lifecycle (Requested → In Review → Completed, with Changes Requested and Cancelled branches), a dedicated comments thread, a status history stepper, per-document upload tracking, and full audit logging of every action. Definitions can be exported as organization templates for reuse across studies, and assigned tasks appear in the site metadata export. See the new Site Tasks documentation.
  • Redesigned AI Chat Experience: The AI assistant has been rebuilt as a persistent side panel with three tabs — Agent, Prompts, and Models — accessible from the “AI Agent” button in the study toolbar. Users can switch between Claude Sonnet 4.6 (recommended default), Claude Opus 4.6, Gemini 2.5 Flash, and Gemini 2.5 Pro per chat. The panel attaches study documents, participant context, and the active artifact (for example, the CRF version currently being edited) automatically, and shows a “Private Mode” tag to reassure users that inputs are discarded after use and never used for model training. Panel state (open chat, selected model, attached context) now persists as you navigate across the study.
  • AI Pathway Builder: The AI assistant can now propose structural changes to a participant pathway as inline “ghost” suggestion cards. Three tools are available — Pathway Outline (proposes section titles and descriptions), Section Detail (populates a section with question groups and activities), and Questionnaire Edit (proposes additions, removals, reorders, or modifications to an existing question group, shown as a coloured diff). Every suggestion can be accepted, accepted-and-continued (which prompts the AI to keep going), or rejected. Available to roles with the “Study AI Prompts” permission — Chief Coordinating Investigator, Deputy Coordinating Investigator, and Study Administrator. See the new AI Pathway Builder documentation.
  • Integrated Site-to-Sponsor Chat: We’ve introduced a secure, real-time communication layer directly within Carelane to replace fragmented email threads. This system features strict site isolation to ensure privacy between different trial locations, while providing study teams with read receipts and unread message status indicators.
  • CRF Signature via Login: Signing a CRF now requires the signer to re-authenticate with their Carelane credentials (and MFA, if enrolled). The “Sign CRF” button opens a Confirm Your Identity dialog that explicitly states “Signing as [Name]” so there is no ambiguity about who is applying the signature. This aligns the signature flow with 21 CFR Part 11 expectations for credentialed, non-repudiable e-signatures.
  • Site Data Entry Status: Sites now carry an explicit Data Entry status (Pending, Open, or Closed Enrollment) that surfaces as a coloured tag on every site card and on the Site Settings page. Closing data entry blocks new participant registrations while allowing ongoing data collection on existing participants — useful when a site has reached its enrollment target or is pausing intake. Status transitions accept an optional reason that is captured in the audit trail.
  • Query Activity Filters: The participant list now offers a Query Status filter with three options — Queries in Progress, Queries in Preparation, and Queries Responded — so study teams can jump straight to participants that need attention. Visual row indicators make responded queries easy to spot, and query counts are denormalised on the subject record for fast filtering across large studies.
  • Reduced Default PHI Requests: The participant enrollment form now requests fewer PHI fields by default. Only essential fields are pre-populated; optional PHI (e.g. subject initials, full date of birth) must be explicitly enabled per study. This supports data-minimisation requirements and reduces the compliance footprint of new studies.

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Stability Enhancements and User Experience Improvements

  • Improved AI PDF Extraction: Uploaded PDFs are now processed by Gemini 2.5 Pro with a revised prompt that preserves tables, diagrams, lists, and markdown structure — and drops page numbers and running headers. Extracted content is cached by content hash, so the same document does not need to be re-processed across AI requests. Both study setup and AI chat benefit.
  • More Reliable PDF Parsing: Resolved a case where uploaded protocol PDFs could fail to parse during AI extraction, causing study setup to error out.
  • Legacy Task Consolidation: The Site Pathway page has been removed to provide a cleaner study interface. Its core settings have been moved to the Site Settings section on the study dashboard, and legacy workflow tasks have been renamed to “Feasibility & Capability” surveys. All existing data remains intact, but future onboarding and general site management should now be handled through the new Site Tasks system.
  • Condition Editor Crash Fix: Fixed a crash that occurred when opening the condition editor on certain pathway steps. The editor now loads reliably regardless of the referenced item type.
  • Report Data Consistency: Fixed a bug where participant reports could display stale data after the underlying participant record had changed. Reports now refresh correctly when participant data updates.
  • Participant Details Breadcrumb Fix: Fixed a case where the participant details breadcrumb did not update correctly when navigating between participants from the site dashboard.
  • MFA Availability Fix: Fixed a configuration error that caused 2FA enrollment to fail. Users can now successfully generate QR codes and link their accounts to authenticator apps for enhanced login security.
  • Notification Email Enhancements: System emails now appear from “Carelane Notifications” with standardized reply-to paths, making it easier for users to identify and organize Carelane-related communications.
  • Streamlined Study Creation: Optimized the study creation process by removing redundant steps. This makes the setup process faster and more intuitive while maintaining all necessary configuration options.

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Version 1.302.0 - 17th of March 2026

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New Features

  • Advanced Participant Pathway Versioning & Lifecycle Management: You can now manage multiple versions of a participant pathway with a formal lifecycle (Draft, Testing, Approved, and Retired). This allows you to safely “dry-run” new study designs in test sites before approving them for the entire study, ensuring data integrity and allowing for safe, iterative design changes without impacting production data.
  • Multi-Model AI Support: We’ve completely overhauled our AI architecture to support multi-model selection, including Claude 4.6 and Gemini 2.5. This update moves AI processing to our secure backend, which enables faster parsing of PDF documents and integrates AI actions directly into the study’s audit logs.
  • 2FA Backup & Recovery: We’ve added backup code support for Multi-Factor Authentication. New 2FA enrollments now include a secure recovery code that can be used at login to reset access. If you are already using 2FA, we recommend re-enrolling to generate your backup code and ensure you have a fallback method.
  • Enhanced Role and Permission Management: A new visual permissions matrix and context role descriptions now clarify exactly what each role can see and do across the platform. You can view the permissions grouped by “Role” or by “Permission” when managing your team and directly see the associated permissions when assigning a new role to a user.

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Stability Enhancements and User Experience Improvements

  • Improved Organization Switching: To ensure security and data consistency, switching organizations now resets your view to the main landing page. This prevents unauthorized data warnings from the previous organization.
  • Query Status Synchronization: Resolved a bug where deleted queries were still being counted in the participant dashboard and overview. We’ve implemented a data migration to resync these statuses, ensuring that the participant list accurately reflects the current state of all queries.
  • Score-Based Conditions: Resolved an issue where the condition editor would not accept values for “Score” items. This allows you to accurately trigger pathway logic based on “Score” items.
  • Site Task Comments Fix: Resolved an issue where comments on assigned site tasks were not visible.
  • Pathway Visualization Fix: Fixed a visual bug in the participant’s CRF where the “Verified” status step would disappear after a record was signed. The CRF now correctly displays both steps simultaneously.
  • Enhanced Timestamp Visibility: All date/time inputs and fields now display the user’s specific time zone. Replaced date-only displays with full timestamps across all participant and record status history tables.
  • Report Sidebar Visibility: Resolved a bug that caused the column and filter sidebar controls to close prematurely and “flicker” when the user is actively modifying columns or filters.
  • Tag Layout Correction: Fixed a visual bug where long study titles would cause tags to be squashed.
  • Signature Audit Visibility: Fixed an issue where the audit trail was not visible when accessed directly from a CRF signature card. Additionally, the signer’s name is now displayed in the password confirmation dialog for better clarity during the signing process.
  • Improved Audit Logging: Added unique User IDs to the audit trail table to help distinguish between users with similar names. The columns “Old Value”, “New Value” and “Change” now show the actual values when exported.
  • Study Deletion Audit Trails: Added audit logging for the permanent deletion of a study. These events are captured within the Organization Unit’s audit trail, ensuring a complete record of study lifecycles from creation to final removal.
  • Document Management Fix: Fixed an error that occurred when deleting text documents quickly after editing them.
  • Enhanced Interactive Feedback: Added subtle hover effects to all clickable cards across the platform. This provides clearer visual cues for interactive elements, making navigation more intuitive.
  • Frontend Performance Optimization: We’ve implemented a caching system for practitioner data to reduce redundant background requests. This results in faster page loads and a snappier experience when navigating between different studies and team views.

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Version 1.290.0 - 11th of February 2026

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New Features

  • Official Carelane Documentation: We’ve launched docs.carelane.io, a comprehensive documentation hub covering everything from role management and study setup to AI features. It includes a full platform changelog and serves as the definitive guide for both new and power users. This is an evolving resource that we will continuously improve and expand to ensure you always have the most up-to-date guidance.
  • Enhanced Study-Aware AI: The AI assistant is now automatically “study-aware.” Every conversation now automatically includes key study metadata, providing more accurate and relevant answers without requiring you to manually attach documents.
  • Capability & Feasibility Export: You can now export task and site data across all study sites in a single structured CSV. This export includes site metadata and detailed task status, using a consistent header format that mirrors our participant data exports for easy analysis.
  • Organization-Level Audit Trails: Carelane now tracks every critical change at the Organization Unit (OU) level. This includes management of members, partner organizations, templates and branding changes (logo/name), ensuring a complete compliance log for administrators.

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Stability Enhancements and User Experience Improvements

  • Streamlined Document Management: We have simplified the study setup by removing the separate “Protocol” template. All protocol-related files are now managed directly within the Documents tab, centralizing your study materials and reducing UI clutter.
  • Site Audit Visibility: Fixed a bug where updates to tasks performed by external users were not correctly appearing in the Site Audit Trail.
  • Infrastructure Hardening: We’ve improved our internal deployment process to enhance testability, platform security and ensure more reliable system updates.

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Version 1.286.0 - 29th of January 2026

This major update introduces a complete overhaul of our audit trail systems, making Carelane more transparent and compliant than ever. We’ve also launched a series of “Quality of Life” features - including a redesigned onboarding flow and significant AI enhancements - to make your daily work smoother and faster.

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New Features

  • New User Onboarding: New users are now greeted with a guided “Welcome to Carelane” section on empty dashboards, providing a personalized greeting and a checklist to help them build their first study and team.
  • AI Protocol Creation Wizard: A new 3-step flow allows you to upload a protocol document (PDF, TXT, or Markdown) and have the AI automatically extract the study title, description, and objectives. This significantly reduces manual setup time while allowing you to review and edit all extracted data before finalizing your study.
  • PDF Support for AI Chat: The AI assistant can now interact directly with PDF documents. You can select existing study PDFs as context for the conversation, allowing the AI to answer questions and extract insights based on the actual content of your protocol documents.
  • New Audit UI: A dedicated audit trail table now features field-level event tracking and JSON diffs, allowing you to see exactly what changed in a record or configuration.
  • Advanced Audit Trails & Compliance: Study definitions, sites, and participant records now feature granular, richer and field-level logging across the platform.
  • Robust CRF Data Modeling: Repeated question groups now receive unique, stable IDs instead of position-based indexes. This ensures that references in audit trails and queries remain accurate and unambiguous, even when repeated entries are added or deleted.

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Stability Enhancements and User Experience Improvements

  • “Jump Back In” Section: Your dashboard now features a “Recently Visited” section that tracks up to 20 of your last locations (studies, sites, participants, or templates) for lightning-fast navigation.
  • Members & Roles Management: A new centralized tab on Study and Site dashboards clearly separates “My Roles” from other study and site members and includes a specialized audit trail for all permission changes.
  • Participant Search: You can now search for participants directly by their pseudonym in the participant overview list.
  • CRF Visual Cues: Mandatory and conditional fields in the CRF editor now feature clear text labels with distinct colors and a new branch icon for conditional logic, making data entry requirements obvious at a glance.
  • Always-On Controls: To improve speed, the edit and collapse buttons in the CRF are now always visible, and hover animations have been removed for a snappier feel.
  • Improved Tag Management: Study team members can now delete participant tags directly from the Study Setup > Participant Tags area.
  • AI Safety: Removed the “All participant data” context option from the AI to prevent incorrect results in large datasets and improve data privacy.
  • Enhanced AI Assistant: We’ve rebranded the AI interface to show the underlying models (Gemini 2.5 Flash and Pro), with Gemini 2.5 Pro now serving as the high-quality default.
  • User Profiles: Fixed a bug where updated phone numbers in the user profile were not being saved correctly.
  • Site Configuration: Resolved an issue where clicking an already-selected task in the site pathway triggered a redundant save and audit event.
  • Performance: Implemented backend optimizations to ensure large audit trails load quickly and reliably.
  • Enhanced Web Security: We’ve optimized the platform’s background security settings to meet current industry standards.