Spot the Difference

The delivery of high quality statistical analyses within stringent time limits is a challenge for any statistical programming group. Meeting delivery dates depends on factors such as the availability and quality of data, finalization of the statistical analysis plan (SAP) and table shells, ad hoc requests, last minute changes etc. Above all you still need to provide high quality even against high-pressure deadlines. Thorough validation and change control of SAS programs and outputs is crucial, but can be time-consuming. Depending on the data volume, as well as the number and complexity of outputs, the repeated execution of all programs can take hours, not to mention the re-validation of hundreds of outputs. At this stage, an efficient process is required to minimize time and personnel expenditure and to increase accuracy in output validation. This paper demonstrates how o archiving of previous data sets and TLGs (Tables, Listings, Graphs) o execution of SAS-programs for generation of ADS (Analysis Data Sets) and TLGs o programmatic re-validation and change control of outputs can be combined in a single macro call. INTRODUCTION For the analysis of a clinical study or the preparation of a meta analysis typically hundreds of outputs, i.e. analysis data sets, tables, listings and graphs need to be produced. Programming and validation always has to be started long before database closure because results need to be available and reliable within a few days after the database has been locked. To facilitate the process of re-running, some kind of SAS program or script is usually applied to enable re-run with just one command. The Macro RMC (Rerun programs and Mark Changes) presented in this paper combines the automatic re-run of programs with the possibility of saving previous outputs and making comparisons against these with the updated versions. RMC displays an overview of which files have been changed and shows all changes in detail. At a late stage of a project when all data sets and outputs have already been validated and change requests arise, the RMC macro is particularly useful in supporting change control. All changes can easily be reviewed and any unintended changes will be detected. At the same time, it can be shown that no changes occurred if RMC displays that no discrepancies were found. SYSTEM ENVIRONMENT The RMC macro was developed at Accovion using SAS on a UNIX operating system and makes use of the interface to the operating system. Hence, the macro combines SAS procedures and data steps with UNIX-specific commands and shell scripts. The UNIX specific elements could be adapted to respective commands for other operating systems, e.g. to make the RMC macro compatible for use on a Windows platform.