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Documentation Index

Fetch the complete documentation index at: https://docs.carelane.io/llms.txt

Use this file to discover all available pages before exploring further.

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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 and self-registration 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.