EDCPRO was developed to meet Sponsor's and Industry requirements with respect to data exchange standards. SCiAN supports data transfers in CDISC - ODM standards, SAS transport files, Excel files and other XML formats. Data from 3rd party sources can be imported in their native format and converted to CDISC - ODM or other formats as needed.
For data provided by 3rd parties that are linked to subject data in the clinical database, the data reconciliation process is as follows:
- Reconciliation programs are programmed in SAS per the requirements defined in the Data Management/Validation Plan
- The eCRF data is exported from the clinical database
- The 3rd party data is downloaded from the source website or provided via secure transmissions
- The data reconciliation programs are executed and a listing of discrepancies is produced
- The resulting output (listings of all discrepancies) is provided to the CDM group for review and query management.