Legacy data conversion planning
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
The first phase, the Data structure mapping is fundamental for understanding and for a proper implementation of the standards.
It is an interactive process between the clients and our experts.
We designed a configuration form in excel for the Data structure mapping. It is filled out in this project phase.
This configuration file is used for
- creation of the Legacy data conversion report and
- automatic creation of the standard datasets.
Various features are considered such as:
- SDTM and ADaM Implementation Guides
- Specific characteristics of the raw data
- Application of Metadata
- Application of Controlled Terminology
- Specific characteristic of SAS
As a result a description of the data conversion process is built in the form of a configuration file with following content such as:
- Specification of the SDTM domains to be generated
- Generation rules for each field of the SDTM domains
- Procedures of the quality assurance
The creation of standard datasets can only be started after the complete approval of the Legacy data conversion plan and report by the client.