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

Area of Science:

• Clinical data management
• Pharmaceutical research informatics

Background:

• Clinical study report appendices require extensive data handling and tabulation.
• Manual appendix generation is a time-consuming and labor-intensive process.

Purpose of the Study:

• To develop an automated system for generating clinical study report appendices.
• To improve the efficiency of creating appendices compliant with CDISC/SDTM standards.

Main Methods:

• Developed the Automated Appendix Generation System (ARGUS).
• Utilized SAS (version 9.3) for core programming and R (version 3.3.1) for PK plot generation.
• System converts database files into MS Word documents with tables and plots.

Main Results:

• ARGUS generates approximately 100 tables and plots within one minute.
• Reduced appendix creation time for a 2x2 crossover study from 8 days to 6-7 hours.
• Ensures compliance with CDISC/SDTM standards.

Conclusions:

• The ARGUS system significantly accelerates the generation of clinical study report appendices.
• Automation enhances efficiency and reduces manual effort in data presentation for regulatory submissions.