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:
- Define of the Legacy data conversion plan and report
- Automatic creation of the SDTM datasets and related files
- Automatic creation of the ADaM datasets and related files
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:
- SDTM and ADaM Implementation Guides
- Statistical Analysis Plan
- ADaM datasets
- Application of Metadata
- Application of Controlled Terminology
- Specific characteristics of SAS
The specification of the ADaM dataset creation is described in a configuration file.
The automatic conversion tool creates:
- the ADaM datasets in SAS Transport Format,
- the Data Definition File define.xml and
- the protocol lists of the quality assurance.
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.