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.