The value that is represented doesn’t change, but the format it’s stored in does. Attributes such as label, type, length, and format must comply with the SDTM attributes. The variable attribute changeĪs well as variable names, variable attributes must be mapped. For example, if the original variable is GENDER, it should be renamed SEX to comply with SDTM standards. Some variables need to be renamed in order to map to the corresponding SDTM variable. These can be directly carried forward to the SDTM datasets, and don’t need to be modified. These are variables that are already SDTM compliant. SDTM Mapping scenarios The direct carry forward If you master these, SDTM mapping becomes much more achievable.

Create custom domains for other datasets that don’t have corresponding SDTM datasets.Īccording to a paper published at PharmaSUG, there are 9 possible scenarios in the SDTM mapping process.

Map variables in the datasets from step 1 to SDTM domain variables.

Gather the metadata of the datasets and the corresponding SDTM metadata.

Identify the SDTM datasets that correspond to those datasets.

If you get familiar with the SDTMIG before you start SDTM mapping, it’ll make the whole process much smoother! Download Now: Free guide on how to overcome the challenges of SDTM clinical trialsĪ typical SDTM mapping scenario contains five steps:

It includes guidance for producing SDTM datasets. The implementation guide gives a detailed overview of SDTM specifications and metadata for all SDTM domains. However, if you don’t, the SDTM Implementation Guide (SDTMIG) is an essential resource. If you’re attempting SDTM mapping and converting data to SDTM, you should have a basic knowledge of how SDTM works. If you’re interested you can read more on SDTM on our blog post All you need to know about SDTM . The best practice is always to align with CDISC standards before you collect any patient data. In order for clinical trial data to be analyzed and accepted by regulatory reviewers, CDISC standards must be adhered to. If CDISC standards haven’t been implemented from the start, it’s going to take a lot more time and effort when it comes to SDTM mapping later on. An example is mapping datasets from the structure used in your clinical data management system, or from another similar database to a CDISC SDTM structure.

That is mapping datasets from a non-CDISC structure to the CDISC SDTM structure. One of the most challenging programming problems in a clinical trial involves SDTM mapping.

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