Automated Generation of Clinical Study Reports

The results of clinical / pre-clinical trials are presented to regulatory agencies in a Clinical Study Report (CSR). A CSR typically consists of a number of tables, listings and graphs each of which are stored as individual files. The process of incorporating these tables, listings and graphs in a CSR is laborious and potentially error prone. An 'automated' technique is presented in this paper which uses SAS® and Windows Scripting Host (WSH) to generate a CSR document populated with specified tables, listings and graphs. This way, parts of CSR can be generated by a simple call to a SAS macro. SAS and WSH can be used to automate routine tasks performed in MS Office. WSH is a powerful and comprehensive utility which facilitates the controlling of Microsoft applications such as MS Word programmatically. The WSH utility allows VBScript programs to run on the Windows operating system as stand-alone applications. The proposed technique uses SAS to generate the appropriate VBScript with parameters, which in turn populates the CSR with the specified tables, listings and graphs. Parameters can include specific folder location, the order and location of these tables, listings and graphs in the CSR.