SAS / SAS programming in
Drug development industry : This tool is
used primary by Clinical Trial Statisticians
to analyse the data as per the statistical
analysis plan (SAP).
Industry guidelines
associated with Statistics / SAS :
1) 21 CRF Part 11
2) E9 - Statistical
Principles for clinical trials
3) E3 - Structure and
content of Clinical study reports
4) E6 - GCP
FDA needs the data sets
to be sent in XPORT file format. They also
accept xml (CDISC) files |