SDTM and ADaM — Explained in simple words!

 The Analysis Data Model is one of the most crucial requirements for clinical trial submission (ADaM). The creation of analysis datasets and related metadata is described in ADaM standards. This ensures traceability and makes it easier for a statistical programmer to produce figures, listings, and tables. As a result, reviewers can evaluate and approve a submission more rapidly.

SDTM and ADaM go hand in hand:

The first thing to understand is how interconnected ADaM and SDTM are, despite the fact that they may serve distinct purposes.

Let's first examine their differences before seeing how they interact.

SDTM (Study Data Tabulation Model)

The model (or framework) used to arrange data from clinical trials including both humans and animals is known as CDISC SDTM. The purpose of SDTM is to clearly describe the structure, characteristics, and contents of each dataset as well as the variables you submitted as part of your clinical trial to regulatory reviewers, specifically the FDA.

Find out Everything that you need to know about SDTM

ADaM (Analysis Data Model)

Compared to SDTM, CDISC's ADaM differs slightly. Although the model is less prescriptive, it still comprises a core model and an implementation guide. Within specific limitations established by the model, more variables may be added. This provides a level of standardization that enables it to be easily understood by reviewers, while giving it the flexibility to be used for any type of study.

How do SDTM and ADaM collaborate, then?

Unlike SDTM, which creates and maps data gathered from unstructured sources, ADaM focuses on producing data that is suitable for analysis. SDTM should ALWAYS be used to create ADaM datasets. The source is always the SDTM datasets, albeit it can be the domain or an additional qualifier.