CDISC Dataset Generator

What is the purpose of this application?

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.

Is the generated data suitable for regulatory submissions?

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.

What are the CRF and TFL shell documents used for?

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.

How can I use the API for programmatic access?

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.

What are specification templates and study protocols?

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.