Introducing Formedix CORE: a free-to-use desktop app incorporating the CDISC Open Rules Engine

Formedix CORE is a free, downloadable Windows desktop application that allows you to validate datasets using the CDISC Open Rules Engine (CORE).  The application provides an easy way to run validations on local data and identify standards conformance issues.

Formedix CORE - CDISC CORE engine
Formedix-CORE-technology preview

Formedix CORE preview version

Formedix CORE is the first desktop application to make use of CDISC CORE and its associated rule sets, which are still in development at CDISC.

This means that you’ll be trying out a preview version of Formedix CORE, to let you explore the technology and see how it can ease clinical study validation.

Test data

CDISC have provided test data for you to try out the Formedix CORE platform and see how to validate study data in practice. The test data is included in the Formedix CORE downloadable zip file.

Why use Formedix CORE?

Easy-to-read validation reports

The sortable and filterable validation reports provide better visibility of your datasets. You can also save the report as an Excel file, for storing or sharing with others. You’ll be able to identify and correct issues early on, resulting in better data quality.

Easily update to the latest rule sets

The app contains a version of the CDISC CORE and the latest version of CDISC’s rule sets (at time of release). You can refresh the rule sets with the latest from the CDISC Library. And because the rule sets are built and governed by CDISC themselves, you can have confidence that you are using the best available rules.

Greater quality and consistency

You’ll align with CDISC’s conformance rules throughout your studies. That means your data will be consistent and high quality and will be as close to submission ready as possible.

Access a support community & give feedback

As a Formedix CORE user, you’ll have access to a community forum. This will enable you to connect with fellow users, get product updates, ask questions and share your experience of the technology. Any feedback you give us will be used to inform changes and improvements we make to the app.

Formedix CORE validation software

How does Formedix CORE work?

Locate your data

Load data from your local XPT datasets.

Select rules

Choose which rules you want to validate against from standardized conformance rules in CDISC’s Open Rules Engine e.g., SDTM-IG 3.4.

Validate against chosen rules

Formedix CORE will validate your data against your chosen rules.

View validation report

The report will display any conformance issues found in your datasets so these can be corrected for better data quality.



Formedix CORE processes your data on your computer. No data leaves your computer and no data is sent to Formedix or to anyone else. See our FAQs section below for more information.

Formedix CORE - platform overview

Fill out the form to get your free download of Formedix CORE


How do I install & get started with Formedix CORE?

How to install and run Formedix CORE for the first time:

Formedix CORE must be downloaded from

  1. Download the latest Formedix CORE .zip file
  2. Extract the zip file
  3. The extracted folder contains the following:
    • the application (Formedix-CORE.exe)
    • application files (core)
    • licensing information (license)
    • system logging information (logs)
    • saved reports (reports)
    • sample datasets (test-data)
  4. To open the application, double-click Formedix-CORE.exe 
    • some users may see the Windows Security Warning and must manually confirm the launch by clicking More info > Run anyway
  5. You can use the sample datasets (provided by CDISC) to familiarize yourself with the application or load datasets from local storage
  6. Head over to our Community site for the Formedix CORE Quickstart Guide
  7. Sign up for an account to give us your CORE feedback.

Formedix CORE is designed to be run without using an installer. This is to minimise IT-related issues that installers can cause.

What is the purpose of the CDISC CORE?

CDISC describes the engine as follows:

“The overall goal of the CORE Project is to deliver a governed set of unambiguous and executable Conformance Rules for each Foundational Standard, and to provide a Reference Implementation of an open-source execution engine for the executable Rules.

CDISC has collaborated with Microsoft and other organizations to develop the CDISC Open Rules Engine (CORE), open-source software, which will execute machine-readable CDISC Conformance Rules retrieved from the CDISC Library. The global clinical research community will be able to leverage the free and open CORE software to test study data for conformance to CDISC standards as well as to regulatory and sponsor-specific conformance rule sets.”

Get more information about CDISC’s Open Rules Engine.

What is the purpose of Formedix CORE?

To help organizations produce better quality, compliant submission deliverables and ultimately, to support the adoption of CDISC’s Open Rules Engine and data standardization.

What environments and data formats are supported?

Formedix CORE is compatible with Windows only. The app supports the data formats supported by the underlying CORE engine. Initially that will be SAS XPT v5.

What plans do you have for upcoming functionality?

The CORE engine is still under development. The following updates are expected to be made by CDISC in a future release, and will be accessible through Formedix CORE:

  • Final production version of CORE engine
  • Final production version of initial rulesets
  • Additional rulesets (SEND, ADaM, FDA business rules)
  • Validation against CDISC NCI terminology
  • Validation of additional file formats, such as CSV, Dataset-XML and Dataset-JSON
  • Validation against additional dictionaries, such as UNII, Med-RT, SNOMED, MedDRA and WHODrug

Does the app take data from my machine?

Formedix CORE processes your data on your computer. No data leaves your computer and no data is sent to Formedix or to anyone else.

On startup, Formedix CORE makes a call to a Formedix server to retrieve information about the latest version of the product. It will inform you of updates and give you the option to download them.