Statistical Analyses and Reporting

• Data base closure
• Creation and validation of SAS programs according to the statistical analysis plan to create tables and graphics, as well as deciding to and generating hypotheses according to study protocol
• In efficacy studies: classification of patients to validity groups according to study protocol (valid for a 'per protocol', an 'intent to treat' and a 'safety' analysis)
• Generation of results in SAS tables, SAS lists and SAS graphics
• Transfer of SAS tables, SAS lists and SAS graphics to MS Word, textual conversion of tables to a tables volume, drawing up of graphics to a graphics volume and making out of lists to a lists volume.
• Drawing up of the final integrated clinical report as a report volume according to the ICH/GCP guidelines