Clinical SAS Course Syllabus
Course Syllabus
Download SyllabusModule 1: Introduction to Clinical SAS
- Overview of SAS in Clinical Research
- Role of Clinical SAS Programmers in the Pharmaceutical Industry
- Understanding the Clinical Trial Process and Phases (Phase I to IV)
- Basics of Clinical Data Management (CDM) and its Importance
Module 2: Base SAS Programming
- Introduction to SAS Software, Interface, and Components
- Data Step Programming: Reading, Writing, and Modifying Datasets
- SAS Libraries and Data Handling Techniques
- Importing and Exporting Data from Excel, CSV, and Relational Databases
- Data Cleaning and Preprocessing using PROC SORT, PROC FORMAT, and PROC CONTENTS
- Using Conditional Statements, Loops, and Functions in SAS
Module 3: Advanced SAS Programming
- PROC SQL for Data Retrieval, Joins, and Subqueries
- Advanced PROC REPORT and PROC TABULATE for Clinical Data Reporting
- Introduction to SAS Macros for Automation and Code Reusability
- Using PROC MEANS, PROC SUMMARY, and PROC UNIVARIATE for Descriptive Statistics
- Debugging and Error Handling Techniques
Module 4: CDISC Standards in Clinical SAS
- Overview of CDISC (Clinical Data Interchange Standards Consortium)
- Understanding SDTM (Study Data Tabulation Model)
- ADaM (Analysis Data Model) Concepts and Implementation
- Creating Standardized Datasets for FDA Submissions
- SDTM Domains and Variable Mapping
- Hands-on Practice in Generating SDTM and ADaM Datasets
Module 5: Statistical Analysis in Clinical Trials
- Basics of Biostatistics and Its Applications in Clinical Research
- Using PROC FREQ, PROC TTEST, and PROC ANOVA for Hypothesis Testing
- Introduction to Survival Analysis and PROC LIFETEST
- Regression Analysis using PROC LOGISTIC and PROC REG
- Generating Statistical Reports for Clinical Trials
Module 6: Clinical Data Reporting and Validation
- Creating Tables, Listings, and Figures (TLFs) for Clinical Trials
- Understanding Case Report Forms (CRFs) and Data Collection Methods
- Generating Patient Profile Listings and Safety Reports
- Handling Adverse Events and Efficacy Data
- Quality Control and Data Validation Procedures
- Good Programming Practices (GPP) in Clinical SAS
Module 7: Regulatory Compliance and Industry Standards
- ICH-GCP Guidelines and FDA Regulations
- Understanding 21 CFR Part 11 Compliance for Electronic Records
- Auditing and Data Submission Standards for Regulatory Agencies
- Good Clinical Practices (GCP) in SAS Programming
Module 8: Real-World Clinical SAS Projects
- End-to-End Clinical Trial Case Study
- Hands-on Practice with Real Clinical Datasets
- Creating and Submitting FDA-Compliant Reports
- Mock Interviews, Resume Preparation, and Career Guidance
In conclusion, our Clinical SAS Certification Syllabus equips learners with the essential skills to master clinical data analysis and statistical programming using SAS. The course covers key topics such as CDISC standards (SDTM & ADaM), clinical trial data management, statistical analysis, and regulatory compliance, offering hands-on experience through real-world clinical datasets and projects. With a structured curriculum, students will gain proficiency in SAS programming, clinical data reporting, and industry best practices essential for the pharmaceutical and healthcare sectors. This Clinical SAS Certification Course is designed to prepare learners for careers in clinical research, biostatistics, and regulatory reporting. Start your journey today and become an expert in Clinical SAS programming!
