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:

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
Various features are considered such as:
As a result a description of the data conversion process is built in the form of a configuration file with following content such as:
The creation of standard datasets can only be started after the complete approval of the Legacy data conversion plan and report by the client.