3rd Party Data Integration – Reconciliation

Data Integration

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.

Data Reconciliation

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.