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Therapeutic Area User Guidance – The hidden Gems

July 28, 2020

CDISC standards have been around for a while with the first SDTM Standard version released in 2004. However, it was only in the last decade that it became “The Standard”, particularly when Health Authorities (HA), such as the US FDA and Japanese PMDA, made it a requirement for data submissions to support most of the regulatory requests for market approval. Additionally, most of the Pharma companies made the CDISC standards a part of their operational data model and consequently, the number of studies using the CDISC standards increased across phases of development.

The benefit of receiving data in standard formats was soon recognized by HA reviewers as they now require lesser time to understand the structure of the data they receive. Integration of data provided by different sponsors, for example on the same indication, for better understanding of safety signals, has become possible with data submitted in standard CDISC format.

However, the HAs such as the US FDA, soon realized that this was not enough, for two main reasons:

  1. sponsors sometimes make bad or different interpretations of the standard
  2. lack of standards or use cases in specific disease areas or indication
The first issue has been addressed by a number of specific HA conformance technical guidance [1,2] and regular public webinars where the HAs presented to the Industry real examples of bad standards implementations [3]. For the second issue, it was soon clear that the gap to be fixed was bigger and required more investment and resources. The CDISC Therapeutic Area User Guidance (TAUGs) are an “attempt” to fill this gap and reduce interpretation, and misinterpretation, of the standards [4].

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