Clinical SAS: Clinical Data Management and Analysis with SAS

Unlock your potential in clinical data management and analysis with our comprehensive Clinical SAS course from Uplatz. Clinical SAS is a powerful software suite from SAS Institute, the industry leader in analytics and business intelligence, specifically engineered for clinical research organizations (CROs) and pharmaceutical companies. Master the tools to efficiently manage, analyze, and report critical clinical trial data.

Key Skills You'll Gain:

• Data Management: Learn to efficiently manage and integrate data from diverse sources, including electronic health records (EHRs), case report forms (CRFs), laboratory data, and patient diaries. Develop expertise in data integration for streamlined clinical trials.
• Statistical Analysis: Become proficient in a comprehensive suite of statistical tools for clinical trial data analysis. Cover topics like descriptive statistics, hypothesis testing, regression analysis, and survival analysis.
• Reporting & Visualization: Create impactful reports, tables, graphs, and dashboards to effectively communicate your findings and insights. Learn to visualize data for clear and concise presentations.
• Regulatory Compliance: Understand and apply regulatory requirements and standards, including FDA 21 CFR Part 11, to ensure data integrity, security, and compliance.
• System Integration: Explore how Clinical SAS integrates with other essential systems like electronic data capture (EDC) systems, clinical trial management systems (CTMS), and data warehouses.

Clinical SAS Course Curriculum:

This course provides a deep dive into all aspects of Clinical SAS, equipping you with the skills needed to accelerate drug development.

• Clinical Research Fundamentals:
  • Historical and Ethical Background of Clinical Research & ICH-GCP Guidelines
  • Essential Documents in Clinical Research
  • Drug Development Lifecycle
  • Clinical Trial Process and Roles
  • Clinical Trial Design Strategies
  • Clinical Trial Monitoring Techniques
  • Clinical Research Terminology Glossary
  • Sponsor Responsibilities & Site Selection
  • Investigator & Clinical Research Coordinator (CRC) Responsibilities
  • QA and QC Audits & Inspections
  • Addressing Non-Compliance, Fraud, and Misconduct
  • Understanding 21 CFR Part 11
• Clinical Data Management:
  • Protocol Understanding
  • Clinical Data Management (CDM) Principles
  • Protocol Assignment
  • CRF Design & Format (including a design demo)
  • Clinical Data Standards
  • CDM Study Start-Up Procedures
  • CDM - EDC Setup Concepts
  • CDM - EDC Study Conduct Concepts
  • CDM - EDC Study Conduct Discrepancy Management
  • CDM - Discrepancy Management Techniques
  • Data Management Plan Development
  • Project Management for Data Managers
  • Vendor Selection & Management
  • Edit Check Design Principles
  • EDC Study Closeout Procedures
  • CDM Study Closeout Processes
  • CRF Completion Guidelines
  • Database Validation & Programming
  • Laboratory Data Handling
  • External Data Transfer
  • Patient Reported Outcome (PRO) Data
  • Investigator Meeting Protocols
  • Metrics in CDM
  • Ensuring Data Quality
  • Measuring Data Quality
  • Safety Data Management
  • Safety Data Reconciliation
  • Medical Coding
  • Clinical Data Archiving
  • Data Entry & Processing
  • Role & Responsibilities of CDMs
  • Medical Device Trials CDM considerations
• Clinical Research Q&A:
  • Clinical Data Management Q&A
  • Clinical Research CDM Fundamental Q&A
  • Working with CROs and Standard Operating Procedures (SOPs)
  • CDISC Standards - Part 1
  • CDISC Standards - Part 2

Benefits of Learning Clinical SAS:

• Streamline Drug Development: Improve efficiency throughout the clinical trial process.
• Make Informed Decisions: Leverage data-driven insights for better outcomes.
• Accelerate Time to Market: Reduce development timelines and bring therapies to patients faster.
• Enhance Data Quality: Ensure accurate, reliable