CC03
Streamlining SASŪ Data Listings to Match CRF Data Flow for Use in Limited Internal Audits
Michael Acra, Glaxo Smith Kline
Greg Henkle, Glaxo Smith Kline

At Glaxo Smith Kline we use a proprietary electronic data capture (EDC) tool to database clinical study data. Before authorizing a database, an internal audit is performed to compare the eCRF data printout from Microsoft Access tables with the processed d ata that is extracted from the EDC output into SAS data sets. The converted data sets are uploaded to the VAX for further processing, data checking, and printing. The data set print utility is written using SAS 6.08 on the VAX and is comprised of three ma cros that work in tandem to produce the printed output in the desired data sequence for a 10% random list of subjects to be sampled. The eCRF order of variables and data sets repeats in the printed output for each subject. This allows for a direct compar ison between the original EDC tables and the SAS data sets found on the VAX.