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.