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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 |
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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 |
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