Checkpoint checklist for ADaM submission package and SAS Macros for package validation / 中国临床药理学与治疗学

FDA clearly provides the rules for drug submission and requires that all the studies which are suitable in electronic format should follow CDISC standard.Due to the detailed contents of submission package,it's always a big challenge to submission institution and staff.It usually costs a lot of time for company or member to complete the validation before submission to FDA.Based on the ADaM submission package,this paper gives a clear picture of validation checkpoint checklist.For every checkpoint,it will see and find the ways to automatically validate through SAS macros or tools.So that it will decrease the manual checking workload,saving the time and shorten the submission period.

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.