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
