CDISC SDTM All You Need To Know

Healthcare plays an invaluable role in our society and is made up of a number of different roles and functions coming together to care from the nation. From emergency care to elderly and disabled care. In this blog we are going to explore the impact clinical trials can have on healthcare and how they can benefit us all.  CDISC SDTM also known as the Clinical Data Interchange Standards Consortium and the Study Data Tabulation Module are both important tools that are used in the US to benefit healthcare which we will explore in this guide.


What Are Clinical Trials And How Does CDISC SDTM Apply To Them

Clinical Trials are forms of medical research that are organised by a variety of different groups from crowdfunded think tanks to universities and charity funded independent work. Clinical trials can often vary in what objectives and outcomes are but ultimately the main goal of most trials is to further medical research and help aid treatment. Common clinical trials may research illnesses such as cancer or malaria which are deadly and need more solutions. In the US CDISC SDTM play an important role amongst Clinical Trials as anyone conducting trials must follow their guidelines.  Clinical Trials can take a number of different forms and can run up costs in millions depending on the scale of the trials and the equipment and participants required to undertake it.




CDISC SDTM come hand in hand when it comes to clinical trials in the United States as both have factors that intertwine and effect each other. Here are some of the key attributes of both:

  • CDISC- The Clinical Data Interchange Standards Consortium is a group that was formed to ensure that data is recorded accurately to improve overall standards of data
  • CDISC- Can be divided into two separate main forms: data models and concept models. Data models vary from concept models as they are made up of data or meta-data. They define how something may be described. Content models in contrast define what is allowed within a dataset.
  • SDTM- The Study Data Tabulation Module is a guide that sets out a structure for clinical data trials. SDTM can be described as a branch of CDISC as it helps to enable its guidelines.
  • SDTM- Is made up of two main factors/standards – the core model defines a number of different factors that can be affected by different variables. The second factor also known as known as the implementation guide defines a set of standard domains. A domain is essentially an observation that has been made during our outwith the trial which related to the trial.

Advantages Of SDTM

  • Data is more accurate and effective between studies so this means that there are less mistakes made and less time needs to be spent on study helping to free up resources elsewhere
  • There is a global community online which can help provide support in relation to any questions or queries you may have
  • SDTM can help make cross platform data interchange much easier