After case report data and external data are collected, the EDC system exports the data into ODM-based XML files or SAS datasets. The Study Reporter is the package that creates all the study datasets, and analysis reports.
Before starting the dataset creation, raw data provided by the EDC system is checked by the Raw Data Validator for both data structure and content consistency. The Raw Data Validator utilizes the validation spec created from Edit Checks, or Sponsor edit checks developed independently. All of the validation results are stored in the Central Repository for reporting and tracking purposes.
Through CDASH standards built into the platform, the EDC system already provides "SDTM like" raw data,. In step 4, all sources of data are integrated and relevant data relationships are generated.
For legacy raw data, the complete SDTM spec developed at the CRF design stage is used to drive the SDTM transformation. The Define.xml document is created to contain the SDTM metadata.
The ADaM Generator takes the SDTM data as input, and creates the analysis datasets based on ADaM specs. ADaM datasets contain derived elements required to support one-proc-away study report creation. The Define.xml document is created to contain the ADaM metadata.
The TLG Creator will then take the ADaM datasets as inputs, and generate all the TLG reports based on TLG specs. In addition, patient profiles or ad-hoc reports are generated through a PPV viewer.
Functional Components of Study Reporter