SDTM 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
After the Legacy data conversion plan was successfully completed and approved by the client, the project enters the second phase, the creation of the SDTM datasets and related files.
We developed a conversion tool that creates automatically:
- SDTM datasets from the raw clinical data in SAS Transport Format,
- the related Data definition File define.xml and
- the protocol lists of the quality assurance.
The conversion tool uses the configuration file created in the previous Legacy data conversion planning phase. Therefore further software development is not needed.
In addition, an annotation of the blank Case Report Form PDF file is prepared.
The created SDTM datasets and define.xml are checked using the OpenCDISC validator tool.