Development of an automated appendix generation system (ARGUS) for clinical study reports.
10.12793/tcp.2017.25.1.34
- Author:
Dooyeon JANG
1
;
Seunghoon HAN
;
Dong Seok YIM
Author Information
1. Department of Clinical Pharmacology and Therapeutics, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea. yimds@catholic.ac.kr
- Publication Type:Original Article
- Keywords:
ARGUS;
CDISC;
CSR;
appendix
- MeSH:
Appendix*;
Clinical Study*;
Cross-Over Studies;
Writing
- From:Translational and Clinical Pharmacology
2017;25(1):34-42
- CountryRepublic of Korea
- Language:English
-
Abstract:
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.
