Off-line Data Validation

For databases that are not built on EDCPRO, SCiAN can develop programs to validate eCRF data off-line.  Programs are developed and tested by Programmer Analysts.

The process is as follows:

  • Off-line validation checks are defined in the Data Management/Validation Plan
  • The validation checks are programmed in SAS
  • On request, the eCRF data is downloaded from the study database and the validation programs executed on the data.
  • The resulting output (listings of all discrepancies) is provided to the CDM group for review and query management.