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 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.
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.
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.
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.
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.
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.
Load data from your local XPT datasets.
Choose which rules you want to validate against from standardized conformance rules in CDISC’s Open Rules Engine e.g., SDTM-IG 3.4.
Formedix CORE will validate your data against your chosen rules.
The report will display any conformance issues found in your datasets so these can be corrected for better data quality.
How to install and run Formedix CORE for the first time:
Formedix CORE must be downloaded from formedix.com
Formedix CORE is designed to be run without using an installer. This is to minimise IT-related issues that installers can cause.
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.”
To help organizations produce better quality, compliant submission deliverables and ultimately, to support the adoption of CDISC’s Open Rules Engine and data standardization.
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.
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:
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.
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