ADaM datasets creation

Clinical data of increased complexity come from multiple sources and in variable formats.

The Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) standards were designed to support submission by a sponsor to the FDA.

The creation of the entire data packet is carried out within the framework of a project with the following steps:

As the SDTM datasets are available, the project enters the third phase, the creation of the ADaM datasets and related files.

Various features will be considered such as:
The specification of the ADaM dataset creation is described in a configuration file.

The automatic conversion tool creates:
Furthermore, it is possible to create the Reviewer's Guide, as far as the necessary legwork of the client is ready.

The created ADaM datasets and define.xml is checked using the OpenCDISC validator tool.