Training in SAS Clinical Programming

Understanding the environment and setting the stage ► Regulatory Environment: Requirements, Standards and Clinical Data · US Code of Federal Regulations (CFR) Title 21 Part 11 requirements · Creating the required documentations for effective impact · FDA expectations and QA Audits · Clinical data flow and structure ► Overview of Regulatory Processes and SAS Techniques · Process for creating and validating output · Various techniques to address requirements · Sample Clinical Study - Summary Table, Data Lists, Graph · Analysis of potential set backs ► Understanding and Applying the QC Plan · Differences between Quality Control and Reviewer/Quality · Assurance · Applying methods to validate programs from QC Plan · Completing tasks with Validation Documentation Producing Summary Tables, Data Lists and Graphs ► Programming standards, conventions and training for improved Productivity · Program Index and Directory Structure for better organization · Software Development Life Cycle (SDLC) for accurate, reliable, and validated results · Information in the Program Header · Anatomy of a SAS Application Program ► Creating Summary Tables, Data Lists, and Graphs · Developing Summary Tables · Developing Data Lists · Developing Graphs · Clinical Trials Reporting Templates ► Identifying data-related issues using edit checks and validation macros · Focus on generating output instead of writing SAS code · Easier to read SAS code that would traditionally be lengthy · Power and flexibility of Proc SQL for queries and validation · Data integrity with edit checks as PDF file · Automate communication of updated data sets and output files