Everything you need to install CTDashboard, connect your clinical trial data, and start reviewing safety signals. Download, import, review – in minutes.
CTDashboard is a free Windows desktop application. No account, license key, or admin rights are required.
.exe file. The installer runs in user space – no administrator privileges are needed.Tip: CTDashboard installs to your user profile directory, so it works on locked-down corporate machines where you cannot install system-wide software.
CTDashboard works with CSV files exported from any Electronic Data Capture (EDC) system, including Medidata Rave, Oracle InForm, Veeva Vault CDMS, and others.
Import your data in CDASH (operational/collection) format directly. There is no need to run SDTM transformations before loading data into CTDashboard.
CTDashboard automatically detects and maps 14 standard clinical domains from your CSV files:
DM Demographics
AE Adverse Events
LB Labs
VS Vitals
CM Concomitant Meds
MH Medical History
DS Disposition
EX Exposure
SV Subject Visits
FA Findings About
CE Clinical Events
PR Procedures
SS Subject Status
SC Subject Characteristics
CTDashboard provides 12 interactive dashboard pages covering the full safety monitoring workflow.
High-level KPIs, incidence rates, enrollment curves, and treatment arm comparisons – your starting point for every safety review.
Population summaries, age/sex/race distributions, and treatment arm balance assessments.
Subject flow diagrams, screen failure rates, and discontinuation reasons by treatment arm.
SAE review tables, forest plots for treatment comparisons, MedDRA drill-down from body system to preferred term, drug-related AE analysis, and severity breakdowns. Chart subtitles show active filter logic.
Shift plots, trend charts over time, reference range flagging, and Hy's Law screening for hepatotoxicity signals.
Vital sign trends across visits, outlier detection, and treatment arm comparisons for blood pressure, heart rate, temperature, and more.
Medication usage patterns, ATC classification breakdowns, and temporal overlap with adverse events.
Kaplan-Meier survival curves, time-to-event analysis, and hazard ratio estimates.
Per-subject deep dive across all domains. View a single subject's demographics, events, labs, vitals, and medications on one screen.
Generate clinical narratives using AI. Produces safety summaries, lab analyses, and adverse event write-ups. Requires an AI API key.
Build your own charts, tables, and views by selecting domains, variables, and visualization types.
Load a previous data export as a baseline and see new, modified, and removed records per domain. Self-contained incremental review workflow.
A persistent sidebar provides filters that apply across all dashboard pages:
All filters support multi-select. When you change a filter, every dashboard page updates reactively to reflect the current selection.
| Action | Shortcut |
|---|---|
| Open / Connect Data | Ctrl + O |
| Save Workspace | Ctrl + S |
| Export to PowerPoint | Ctrl + E |
| Next Dashboard Page | Ctrl + Tab |
| Previous Dashboard Page | Ctrl + Shift + Tab |
| Toggle Sidebar Filters | Ctrl + B |
| Search Subjects | Ctrl + F |
| Open Settings | Ctrl + , |
The AI Patient Narratives feature uses AI to generate clinical narrative text from your safety data. This is an optional feature that requires an AI API key.
Important: AI-generated narratives are a starting point. Always review, verify, and edit the output before including it in any regulatory submission or clinical document.
Workspaces let you save and restore your session configuration so you can pick up where you left off.
Privacy note: Workspace files store file paths, reviewer notes, and preferences only – they never contain clinical data. Your trial data is never written to disk by CTDashboard.
The Comparison tab is a self-contained page for incremental safety review. Load a previous data export as a baseline, and CTDashboard shows you exactly which records are new, modified, or removed – organized by clinical domain.
Click “Clear Comparison” on the Comparison tab to discard the baseline and return to normal single-dataset mode. Other dashboard tabs are unaffected.
The baseline load uses the same field mappings (including any user corrections from the mapping dialog) as your primary data. You do not need to re-map columns for the baseline.
All comparison processing happens in memory. The baseline file paths are saved in your workspace file for convenience, but no clinical data from the baseline is stored. When you close the application, all comparison data is released from memory.
CTDashboard supports multiple export formats for sharing safety data with stakeholders:
CTDashboard ships with an automated validation engine that independently recalculates every displayed value and compares it against the application’s output, with computation evidence and app screenshots.
The report independently verifies the following analytics modules using raw data and pandas calculations that are separate from the application’s rendering pipeline:
The report is a functional verification tool, not a full Computerized System Validation (CSV) package. It does not include:
For regulated use, we recommend treating CTDashboard as a visualization and review aid. Cross-validate key findings against your CRO’s independent SAS/R output before including in regulatory submissions. For GAMP 5 classification, risk assessment, and formal vendor-file documentation, see the Validation Summary below. See the For Sponsors page for full regulatory positioning guidance.
Within CTDashboard, go to File > Export Validation Report. The report is generated as a standalone HTML file that can be opened in any browser and saved as PDF for your study files.
Download sample Validation Report (PDF)
For sponsors needing a formal document for their vendor qualification file or computerised system inventory, CTDashboard provides a Validation Summary. This companion document covers:
CTDashboard is designed with regulatory requirements in mind. This section explains how the application handles clinical data and how it aligns with industry standards for data privacy and integrity.
CTDashboard never stores, caches, or persists clinical trial data to disk. All CSV data is loaded into working memory (RAM) when you open your files and is released completely when the application is closed. There is no local database, no temporary files containing patient data, and no background syncing.
Clinical data never leaves your machine. CTDashboard does not connect to external servers, cloud services, or analytics endpoints. The application runs entirely offline with one exception: AI Patient Narratives (if enabled) sends the selected subject's data to the AI provider you configure. This feature is opt-in and disabled by default.
When you save a workspace, CTDashboard stores only file paths, filter selections, reviewer notes, and display preferences. No patient-level data, no identifiers, and no clinical observations are written to the workspace file.
CTDashboard is a read-only visualization and review tool. It does not modify source data, does not maintain audit trails, and is not intended to serve as a system of record. Because CTDashboard never writes or alters clinical data, it operates outside the scope of 21 CFR Part 11 electronic records requirements. Your validated EDC system remains the authoritative source of record.
CTDashboard processes personal data (such as subject demographics) solely in memory during your active session. No personal data is persisted, transmitted, or shared. Since data processing occurs locally on your own hardware and nothing is sent externally, CTDashboard supports GDPR data minimisation and purpose limitation principles. Organizations should still ensure that CSV exports from the EDC are handled according to their own data protection policies.
CTDashboard supports safety monitoring workflows consistent with ICH E6 (GCP) and ICH E2F (DSUR). The DSUR export feature generates ICH E2F-aligned report drafts. All visualizations, signal detection outputs, and AI-generated narratives are intended as review aids and must be verified by qualified personnel before inclusion in regulatory submissions.
When AI Patient Narratives is enabled and you generate a narrative, the selected subject's clinical data is sent to the AI API you configured (e.g., Anthropic, OpenAI). This is the only scenario where data leaves your machine. The data is sent over an encrypted (TLS) connection and is subject to the AI provider's data usage and retention policies. No API key or clinical data is stored by CTDashboard beyond the active session, except the API key itself which is saved in your local settings file.
Summary: CTDashboard is a local, read-only review tool. It stores zero clinical data, transmits nothing by default, and is designed to complement – not replace – your validated EDC and regulatory systems.
No. CTDashboard processes data in memory only. Your CSV files are read from disk when you load them and are never copied, cached, or sent to any server. When you close the application, all data is released from memory.
No. CTDashboard works directly with CDASH (operational/collection) format data exported from your EDC system. No SDTM transformation step is required.
No. AI Patient Narratives is entirely optional. All other dashboard features work without an API key. If you do not configure an AI API key, the AI Narratives page will simply be unavailable.
When you generate a narrative, the selected subject's clinical data is sent to the AI API for processing. This data is not stored by the AI provider and is subject to the AI provider's data usage policies.
CTDashboard is currently a Windows-only desktop application. macOS and Linux versions are not available at this time.
No. The installer runs in user space and installs to your user profile directory. No administrator privileges are required, so it works on corporate machines with restricted permissions.