Hi:
At a very -basic- level, my Pharma students tell me that they use the following methods to produce the tables and graphs they need for clinical trial reporting:
--PROC REPORT
--PROC TABULATE
--SAS/GRAPH with ANNOTATE
--ODS GRAPHICS with Statistical Procedures
--SAS/GRAPH SG Procedures
--SAS Macro Programs
The key thing is getting the data organized appropriately, in the required form and structure required by the FDA. If you look at the PharmaSUG and other user-group papers, which are archived at:
http://www.lexjansen.com, you will find quite a few hits, these among them.
http://www.lexjansen.com/phuse/2008/ad/ad12.pdf
http://www.lexjansen.com/pharmasug/2007/tt/tt14.pdf
http://www2.sas.com/proceedings/sugi22/TRAINING/PAPER320.PDF
http://www.nesug.org/Proceedings/nesug06/po/po23.pdf
http://www2.sas.com/proceedings/sugi26/p129-26.pdf
http://www.lexjansen.com/pharmasug/2009/sa/sa-ad-02.pdf
For more information about the FDA requirements, you should look at the FDA site. In addition, if you work for a Pharmaceutical company or a CRO, it is my experience that every company has their own procedure for validating code logic and producing reports. Some companies produce tables with DATA _NULL_ and LISTING output and have a group create the RTF or PDF files required by the FDA. Some companies use ODS RTF or ODS PDF.
As previously explained the standards are voluminous and the implementation of the standards is equally voluminous.
cynthia
