CDISC Dataset Generator

Generate synthetic CDISC-compliant datasets for clinical research

Generate Blank CRFs
FAQ
Customize dataset with therapeutic area-specific conditions and terminology

SDTM Domains

Standard for Tabulation

ADaM Datasets

Analysis Data Model

SEND Domains

Standard for Exchange of Nonclinical Data

About CDISC Standards

The Clinical Data Interchange Standards Consortium (CDISC) develops and supports global data standards for medical research. This application generates synthetic datasets that comply with these standards:

SDTM

The Study Data Tabulation Model organizes clinical data into standardized datasets with consistent variables, allowing for efficient regulatory submissions.

ADaM

The Analysis Data Model provides standards for creating analysis datasets that are clear, reproducible, and support efficient generation of statistical analyses.

SEND

The Standard for Exchange of Nonclinical Data provides a way to standardize nonclinical or preclinical research data for regulatory submissions.

View Frequently Asked Questions

Frequently Asked Questions

This application generates synthetic clinical trial and nonclinical research data that complies with CDISC standards (SDTM, ADaM, SEND). It helps researchers, data managers, and programmers to quickly generate realistic test datasets for training, validation, and software testing purposes.

No, the generated data is synthetic and intended for training, testing, and educational purposes only. While it follows CDISC structure and formatting guidelines, it should not be used for actual regulatory submissions or clinical decision-making. The datasets are designed to mimic real clinical data but do not represent actual patient information.

The application currently supports the following formats:
  • CSV - Comma-separated values file that can be opened in Excel or other spreadsheet applications
  • SAS Program - SAS code that can recreate the dataset when run in SAS
  • SAS XPT - SAS Transport (XPT) format commonly used for FDA submissions
Note: CDISC JSON format support has been temporarily disabled and will be available in a future update.

CRF (Case Report Form) documents are blank forms used to collect clinical trial data. Our generated CRFs are designed for SDTM annotation practice, helping users learn how to map CRF fields to SDTM variables.

TFL (Tables, Figures, and Listings) mock shells are templates used in clinical study reports. They help statistical programmers practice creating output displays for clinical trial results. These can be downloaded in both PDF and RTF formats.

You can access all functionality programmatically through our REST API. Click the "API Documentation" link in the footer to view complete documentation with example requests and responses. The API allows you to generate datasets, retrieve available domains, and access therapeutic area information without using the web interface.

Specification templates are Excel files that outline the structure and attributes of SDTM or ADaM datasets. They're used by data managers and programmers to document dataset specifications before implementation.

Study protocols are comprehensive documents that describe the objectives, design, methodology, and organization of a clinical trial. Our generated protocols align with the selected therapeutic area, number of treatment arms, and study phase to provide realistic examples for educational purposes.