SDTM – The Study Data Tabulation Model

What is the SDTM?

The SDTM is a CDISC content standard that describes the core variables and domains to be used as a standardised submission dataset format for the Food and Drug Administration (FDA). Define.xml holds the metadata for these datasets.

SDTM data is submitted in the proprietary SAS transport file format which is not a CDISC model.  Moves are afoot to ultimately replace this with an HL7 message.

The model itself has several key concepts, the main one being that domains should be split up according to Findings, Interventions, Events and Special Purpose domains.

CDISC have separated the implementation guide from the underlying content standard.  This separation enables implementation guides corresponding to different standards to be produced which all build upon the underlying core model.

The SDTM implementation guide specifies the core safety domains and their variables e.g. adverse events, concomitant medications etc: all the common elements of a clinical trial.

In order to create therapeutic specific domains, a designer would pick from the relevant superset of Findings, Interventions and Events variables found within the core SDTM standard.  Each new domain would have its own two letter abbreviation.

The SDTM is a well thought through model that allows companies to add additional variables outside of the CDISC control variables by means of supplemental qualifiers.

Business Benefits of Using SDTM

Standardized Dataset Format

The SDTM facilitates communication between CRO’s and sponsors or sponsors and regulators.  Regulators in particular benefit from the standard: the FDA can begin to perform meta-analysis of safety across new drug entities from multiple companies for example. 

The FDA has invested significant sums of money in data warehouse tools for such a purpose (JANUS) and in training reviewers to understand these structures.

With standardized variables and domains, queries to pharmaceutical companies about the structure of their submissions should be reduced. 

The SDTM is named in regulatory guidance as the recommended submission format and it is proposed that the SDTM be regulated for in the near future.

Formedix Products which use the SDTM to help you in your Clinical Trials Process:

• Origin^TM Submission Modeller – A dedicated SDTM and proprietary dataset definition tool utilising define.xml