• Overview of clinical trials
• Phases of clinical trials (Phase I–IV)
• Role of SAS in clinical research
• Clinical data lifecycle
• Regulatory bodies overview (FDA, EMA)
• Career opportunities in SAS Clinical
• Phases of clinical trials (Phase I–IV)
• Role of SAS in clinical research
• Clinical data lifecycle
• Regulatory bodies overview (FDA, EMA)
• Career opportunities in SAS Clinical
• Clinical trial study design
• Case Report Forms (CRFs)
• Source data vs clinical data
• Clinical databases overview
• Types of clinical data
• Data flow in clinical trials
• Case Report Forms (CRFs)
• Source data vs clinical data
• Clinical databases overview
• Types of clinical data
• Data flow in clinical trials
• Review of Base SAS concepts
• SAS datasets and libraries
• SAS data step fundamentals
• PROC overview
• Clinical programming workflow
• SAS log and output understanding
• SAS datasets and libraries
• SAS data step fundamentals
• PROC overview
• Clinical programming workflow
• SAS log and output understanding
• Importance of CDISC standards
• Overview of SDTM and ADaM
• CDISC implementation guide
• Controlled terminology
• Regulatory submission requirements
• Benefits of CDISC compliance
• Overview of SDTM and ADaM
• CDISC implementation guide
• Controlled terminology
• Regulatory submission requirements
• Benefits of CDISC compliance
• SDTM structure and domains
• General Observation Classes
• Demographics (DM) domain
• Adverse Events (AE) domain
• Concomitant Medications (CM) domain
• Vital Signs (VS) domain
• Mapping CRF data to SDTM
• SDTM variable conventions
• Creating SDTM datasets using SAS
• Validation of SDTM datasets
• SDTM compliance checks
• SDTM best practices
• SDTM variable conventions
• Creating SDTM datasets using SAS
• Validation of SDTM datasets
• SDTM compliance checks
• SDTM best practices
• Purpose of ADaM
• ADaM dataset structure
• Subject-level analysis dataset (ADSL)
• Analysis datasets (ADAE, ADLB, etc.)
• Traceability concepts
• ADaM compliance requirements
• ADaM dataset structure
• Subject-level analysis dataset (ADSL)
• Analysis datasets (ADAE, ADLB, etc.)
• Traceability concepts
• ADaM compliance requirements
• Creating analysis-ready datasets
• Deriving variables
• Handling missing and derived values
• Baseline and change calculations
• Population flags
• Analysis dataset validation
• Deriving variables
• Handling missing and derived values
• Baseline and change calculations
• Population flags
• Analysis dataset validation
• Tables, Listings, and Figures (TLFs)
• Clinical summary tables
• Patient listings
• Graphical figures
• Regulatory reporting formats
• Output standards
• Clinical summary tables
• Patient listings
• Graphical figures
• Regulatory reporting formats
• Output standards
• Descriptive statistics
• Inferential statistics overview
• Hypothesis testing basics
• P-values and confidence intervals
• Clinical significance vs statistical significance
• Role of statistics in analysis
• Inferential statistics overview
• Hypothesis testing basics
• P-values and confidence intervals
• Clinical significance vs statistical significance
• Role of statistics in analysis
• PROC MEANS and PROC SUMMARY
• PROC FREQ usage
• PROC REPORT for clinical outputs
• PROC TABULATE basics
• Generating clinical tables
• Formatting outputs
• PROC FREQ usage
• PROC REPORT for clinical outputs
• PROC TABULATE basics
• Generating clinical tables
• Formatting outputs
• Safety data analysis concepts
• Adverse events analysis
• Laboratory data analysis
• Efficacy endpoints
• Time-to-event basics
• Clinical interpretation
• Adverse events analysis
• Laboratory data analysis
• Efficacy endpoints
• Time-to-event basics
• Clinical interpretation
