Development of an automated appendix generation system (ARGUS) for clinical study reports

Data handling and tabulation are a time-consuming job when writing appendices for clinical study reports. The authors have developed an automated appendix generation system (ARGUS) conforming to the CDISC/SDTM standard using SAS (version 9.3) and R (version 3.3.1: for PK plot generation). It consists of the one main program and three subprograms. The program runs to convert a database file into an appendix document with about 100 tables and plots in MS Word format within one min after pressing the submit button under common desktop environments. We found that tasks of constructing appendices for a typical 2×2 crossover design study that have taken our team about 8 days were completed within 6 or 7 hours using the ARGUS system.