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Introduction to CDISC standards

//Introduction to CDISC standards
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Introduction to CDISC standards

The Clinical Data Interchange Standards Consortium is an organization dedicated to helping improve medical research by driving interoperability through data standardization.

Formedix have been strong advocates for the use of CDISC data standards in clinical and non-clinical research for half my life now, ever since we realised how it could transform our business by enabling the rapid design and build of clinical trials. We quickly focused our company around use of CDISC standards, and are now industry leaders in CDISC software, professional services and training.

By working together using the same standards we can optimize our clinical trials by increasing data quality and reducing design and execution time. Ultimately that means getting more products to the market with less cost.

 

Data models vs content models

CDISC produce two main types of standards, which I’ll call “data models” and “content models”. Data models are ways of describing data or metadata. Think PDF or Excel.  They define how you describe an object. Content models define what objects are allowed. Think of an Adverse Events dataset and the variables it contains.

CDISC Operational Data Model (ODM) and CDASH

CDISC ODM is a data model that is used to define operational data, such as CRFs, ePRO or IVRS systems. By defining these in a standard way they become easier to re-use, quicker to validate, and more interoperable. Managing metadata standards in a system independent way becomes possible, so you can define organizational standards that can be used regardless of your chosen data capture solution. ODM can also be used to import and export clinical data from various systems.

CDASH is a content model that defines how best to structure your case report forms (CRFs), to ensure you gather the data you require and that it can easily be used for a standardized SDTM submission.

You can use ODM and CDASH together to rapidly define the data you need to collect in your clinical trials.

Take a look at our blog about using ODM and CDASH for CRF design.

CDISC Define-XML

CDISC Define-XML is a data model that defines tabular dataset structures. This includes system-specific dataset structures that are exported from an EDC system, or standardized CDISC domains such as SDTM. It can be used to drive process efficiencies throughout the clinical life cycle, and must be used to describe your submission datasets when submitting to regulators such as FDA or PMDA.

Find out more in our blog about using Define-XML for dataset design.

CDISC SDTM, ADaM and SEND

CDISC define content models to help standardize regulatory submissions. FDA now require studies to be submitted using “standardized data”, which means using CDISC Study Data Tabulation Model (SDTM), Standard for the Exchange of Non-Clinical Data (SEND), and Analysis Data Model (ADaM). These standards make it easier for a regulator to understand your trial data. Being able to easily work with SDTM, ADaM and SEND datasets is a key part of any trial process.

See our blog about using SDTM, ADaM and SEND for regulatory submissions.

NCI Controlled Terminology

CDISC have partnered with the National Cancer Institute (NCI) to publish an evolving set of terminology standards. These are used along with content standards like SDTM to help ensure that the content of the data is easy to understand.

Here’s out blog on using NCI Controlled Terminology for standardizing data.

Want to know more?

Formedix have been using CDISC to help drive efficiencies in clinical research for nearly twenty years, and have made major contributions to the development of the standards to ensure they provide maximum benefit to the industry.

We have an extensive suite of products to enable you to take advantage of CDISC standards and optimize your trial process.

If you have any questions about CDISC or would like to know how you can use it to your benefit, we have a team of experts that can help you use CDISC to accelerate your clinical trials. We can also provide various types of CDISC training to help get you up to speed.

 

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