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2024 - Automation & Modernization

# Release Notes
Last updated: 04/14/2026

A month-by-month summary of new features, enhancements, and improvements delivered to the ClinicalDataS platform in 2024, focusing on automated data rules, medical coding, and clinical supply management.

Overview​

The year 2024 marked a foundational transformation for the ClinicalDataS platform. We shifted from a standard data capture tool to an intelligent, highly configurable clinical system. Major milestones included the launch of the advanced Automated Rule Engine, the integration of Medical Coding, the foundational setup for comprehensive Investigational Medicinal Product (IMP) management, and the introduction of the Survey & eConsent modules.

For detailed, screen-by-screen instructions on how to use these features, please refer to the specific module documentation linked in the "Learn More" section.

🎁 December 2024: Survey Maturity, eConsent & IMP Receipts​

AreaWhat it is for
Survey ModuleEnhanced data loading, participant invitations, and screening survey integration.
eConsent WorkflowsDigital signature capture, LAR (Legally Authorized Representative) support, and form versioning.
IMP Configuration & ReceiptsComprehensive setup for warehouses, products, units of measure, and receipt creation.

Key Updates

  • Survey Module: Matured the Survey experience with robust data loading for participant-specific responses, seamless integration with the Screening module, and the ability to invite participants directly from the enrollment tab.
  • eConsent Workflows: Launched core eConsent capabilities, including digital signature capture for participants and LARs, counter-signatures by staff, form archiving/publishing, and the ability to upload signed paper consent forms.
  • IMP Configuration & Receipts: Rolled out deep configuration tools for IMP (Warehouse management, Physical inventory sites, Collect wasted reasons, Products, and Unit of Measure categories). Introduced the Receipt Matrix and creation workflows for logging incoming drug shipments.

🍂 November 2024: Survey Module Launch & Advanced Randomization​

AreaWhat it is for
Survey BuilderTools for creating, configuring, and distributing participant-reported outcome surveys.
Randomization AnalyticsEnhanced statistics, stratification charts, and request management for un-blinding/un-randomizing.
Data Entry & Study HomeNew right-sidebars for issues/queries, pre-screen columns, and study dashboard chart exports.

Key Updates

  • Survey Builder: Introduced the foundational Survey Module, allowing study builders to create standalone survey packages, configure public/private access, set up participant groups, and track completion rates directly from the Study Home.
  • Randomization Analytics: Empowered study managers with detailed stratification statistics, randomized subject detail pages, and formal workflows to request and approve "Un-Randomize" or "Un-Blind" actions.
  • Data Entry & Study Home: Enhanced the Data Entry experience with a right-sidebar for real-time query and issue tracking. Upgraded the Study Home dashboard with zoomable, exportable charts and a new "Pre-Screen" column in the Event & CRF matrix.

🍁 October 2024: Rule Engine Automation & Randomization Workflows​

AreaWhat it is for
Rule EngineAutomated data validation, conditional display, and default value population within CRFs.
Randomization SetupIntuitive configuration for stratification, study groups, and randomization positioning.
Subject WorkflowsDynamic group class management, more personal data handling, and audit log integration.

Key Updates

  • Rule Engine: Successfully integrated the visual Rule Studio into the Data Entry engine. Study builders can now create complex conditional logic (e.g., hiding fields based on previous answers), set default values dynamically, and enforce automatic validations without manual effort.
  • Randomization Setup: Upgraded the randomization configuration to support complex stratification factors, study group class assignments, and customizable positioning of the randomization form within specific study events.
  • Subject Workflows: Implemented Dynamic Subject Group Classes, allowing studies to automatically categorize subjects into different cohorts based on real-time data entry. Enhanced the Subject Matrix with robust personal data handling and direct links to audit logs.

📱 September 2024: IMP Waste Management & Mobile Responsiveness​

AreaWhat it is for
IMP Waste & InventoryEnd-to-end tracking of drug waste at both warehouse and site levels, with approval workflows.
Responsive DesignPlatform-wide UI adjustments ensuring seamless usability on tablets and mobile devices.
Data Entry UX"Next/Previous" navigation, simple AE/SAE reporting, and visit information attachments.

Key Updates

  • IMP Waste & Inventory: Expanded the IMP module to include full Waste Management workflows. Users can now track on-hand quantities, process waste/cancellations with configurable "reasons", and handle internal transfers with strict approval/cancellation auditability at both Warehouse and Site levels.
  • Responsive Design: Executed a major responsive design sweep across the platform. Key areas like Study Home, My Tasks, Screening Matrix, Subject Matrix, and Data Entry forms now adapt gracefully to tablet and mobile viewports.
  • Data Entry UX: Significantly improved the data entry workflow by adding "Next/Previous" form navigation, enabling direct file uploads from within the form, and introducing a simplified, configurable AE/SAE reporting section in event forms.

📦 August 2024: Comprehensive IMP Inventory & Responsive UI​

AreaWhat it is for
IMP FoundationInitial setup for Investigational Medicinal Product configuration (Products, Units, Locations, Contacts).
Data Entry TablesNew matrix and group table components for capturing repeating data structures.
Study BuildEmail notification configurations for new enrollments and mobile app setup parameters.

Key Updates

  • IMP Foundation: Laid the groundwork for the IMP module by introducing comprehensive configuration pages for Products, Unit of Measure categories, Warehouse Locations, and Company Contacts.
  • Data Entry Tables: Introduced advanced "Group Matrix" and "Embedded Table" components within the Data Entry module, allowing study builders to capture complex, repeating row data (e.g., concomitant medications) with intuitive add/remove row functionality.
  • Study Build: Added system-level configurations to automatically trigger email notifications when a new subject is enrolled, alongside foundational settings for the upcoming Mobile App experience.

🩺 July 2024: Medical Coding Launch & Data Entry Enhancements​

AreaWhat it is for
Medical CodingIntegrated dictionary coding (e.g., MedDRA/WHODrug) directly within the data entry workflow.
Input Component LibraryUpgraded form inputs (File Input, VAS, Slider, Date/Time) for better UX and cloud storage integration.
Casebook ModuleA comprehensive, subject-centric view of all clinical data and audit trails.

Key Updates

  • Medical Coding: Launched the Medical Coding module, featuring an Alias Management system, auto-coding capabilities, and a seamless interface for coders to review and assign preferred terms to adverse event (AE) and medical history data directly from the data entry screen.
  • Input Component Library: Rolled out a modernized suite of input components, including an upgraded File Input with direct cloud storage integration, improved Visual Analog Scale (VAS) sliders, and better handling of date/time formats across the platform.
  • Casebook Module: Introduced the Casebook module, providing monitors and data managers with a holistic, read-only view of a subject's entire clinical journey, including all form data, audit trails, and randomization status.

🧩 June 2024: Enhanced Data Entry Experience & Medical Coding Setup​

AreaWhat it is for
New Data Entry EngineA rewritten, high-performance experience for Data Entry forms, reducing load times.
Medical Coding MatrixCentralized dashboard for tracking coding status, preferred terms, and aliases.
System SettingsCentralized management of time formats, system logos, and cloud storage connections.

Key Updates

  • New Data Entry Engine: Completely rebuilt the core Data Entry experience to significantly improve form loading times, reduce rendering lag, and provide a much more stable experience when handling complex, repeating form groups.
  • Medical Coding Matrix: Introduced the foundational Medical Coding dashboard, allowing coding teams to track the status of all medical terms, manage aliases, and prepare for standardized dictionary integration.
  • System Settings: Enhanced the System Configuration UI with dedicated sections for managing global time/date formats, uploading system logos, and testing cloud storage connections.

🛠️ May 2024: Automated Data Rules & Modernized Form Inputs​

AreaWhat it is for
Automated Data RulesConnecting the visual rule builder to the core EDC data flow for automatic validations.
Dataset ExtractionTools for study managers to define, filter, and export specific subsets of clinical data.
Query ManagementEnhanced query permissions, email notifications, and audit log tracking.

Key Updates

  • Automated Data Rules: Successfully integrated the external visual Rule Builder into the ecosystem, allowing study builders to define complex validation rules and conditional logic that seamlessly sync with the Data Entry module.
  • Dataset Extraction: Introduced the Dataset Management module, allowing authorized users to define temporal scopes, select specific forms/items, handle non-completed statuses, and export normalized data for statistical analysis.
  • Query Management: Upgraded the Query experience with granular permission checks, automated email notifications when a query is assigned, and deep integration with the subject audit log.

🔍 April 2024: Query Management & SDV Workflows​

AreaWhat it is for
Query Detail PageA dedicated, full-screen view for managing complex, multi-threaded queries.
Source Data Verification (SDV)Flexible setup and execution for SDV at the Event Form and Subject ID levels.
Study Setup UIA step-by-step, user-friendly interface for configuring study events, forms, and apps.

Key Updates

  • Query Detail Page: Upgraded the Query experience with a dedicated detail page, allowing monitors and data managers to view the full context of a discrepancy, add threaded replies, close queries, and view historical audit trails in one place.
  • Source Data Verification (SDV): Rolled out comprehensive SDV workflows, allowing Monitors to verify data by Event Form or by Subject ID, with clear visual indicators and bulk-verification capabilities in the subject matrix.
  • Study Setup UI: Completely redesigned the Study Setup experience, making it easier to configure study parameters, facility information, event definitions, and application installations in a guided, step-by-step manner.

🏗️ March 2024: Study Setup Modernization & System Administration​

AreaWhat it is for
Study Build UICentralized hub for managing sites, users, events, and study group classes.
System AdministrationEnhanced matrices for Audit Login, Email Logs, and User Management with export capabilities.
Subject MatrixUpgraded subject listing with dynamic actions and reassignment tools.

Key Updates

  • Study Build UI: Launched the core "Build Your Study" workflows, including intuitive interfaces for managing Sites, assigning Study Users, defining Events/Forms, and configuring Study Group Classes for randomization.
  • System Administration: Enhanced the Administration module with detailed, exportable matrices for Audit Login trails, Email Logs, and User Management, providing system admins with complete visibility into platform activity.
  • Subject Matrix: Upgraded the Subject Matrix with robust action menus (Edit, Remove, Restore, Reassign) and seamless navigation to Subject Details and Randomization workflows.

🛡️ February 2024: System Configuration & User Role Management​

AreaWhat it is for
Role-Based Access ControlGranular permission management for users, studies, and sites.
System SettingsEnhanced configuration for password policies, login/logout behaviors, and email defaults.
Screening ModuleFoundational workflows for screening setup, editing, and enrolling/rejecting subjects.

Key Updates

  • Role-Based Access Control (RBAC): Introduced a robust permission framework, allowing system administrators to define highly specific access rights for Clinical Research Coordinators (CRCs), Monitors (CRAs), and Study Admins.
  • System Settings: Upgraded the System Configuration UI with dedicated sections for Password Policy enforcement, Two-Factor Authentication (2FA) setup, and Login/Logout session management.
  • Screening Module: Laid the groundwork for the Screening module, featuring configuration screens for screening labels, code generation, and the initial UI for editing, rejecting, and enrolling screened subjects.

🧭 January 2024: Core Foundation, Localization & Navigation​

AreaWhat it is for
Localization & NavigationMulti-language support and a modernized, scalable navigation structure.
Study HomeA redesigned central hub for quick access to study statistics, events, and applications.
All Studies ManagementCentralized administration for creating, removing, and restoring clinical studies.

Key Updates

  • Localization & Navigation: Implemented comprehensive multi-language support (including English and Vietnamese) alongside a completely modernized navigation system to support future mobile and web integrations seamlessly.
  • Study Home: Launched the new Study Home dashboard, providing study managers with immediate visibility into enrollment statistics, active sites, study collapse navigation, and quick links to installed applications.
  • All Studies Management: Introduced the "All Studies" administration view, allowing System Administrators to easily create new studies, manage study statuses (Design, Available, Frozen, Locked), and handle study restoration/removal workflows.

Learn More​

To learn how to use these features in your daily workflow, explore the following documentation sections:

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