Clinical SAS Programming Tutorial for Beginners

Introduction

• Speaker: Naidu, SAS Trainer and Programmer in an MNC, India
• Audience: Non-IIT, Non-programming background individuals
• Objective: To provide an understanding of clinical SAS programming roles, responsibilities, and how to start programming

Topics Covered

1. What is Clinical SAS?
2. Introduction to Clinical SAS Training
3. Role of a SAS Programmer in a Clinical Trial
4. How to Start Writing a SAS Program
5. What is CDISC, SDTM, ADaM, and TLFs?
6. Eligibility to Learn This Course
7. Job Scope of Clinical SAS Programming
8. How to Learn Clinical SAS Programming Step by Step
9. Questions and Answers

Clinical SAS

• Definition: Using SAS software in the clinical industry, mainly pharmaceutical companies, for reporting purposes
• Application: Analyzing clinical trial data to get FDA approval for new drugs

Role of SAS Programmer in Clinical Trials

• Clinical Trial vs Pre-clinical Trial: Trials on humans vs animals
• Process: Administering drugs, collecting data, analyzing and reporting to FDA
• Importance: SAS programmers must analyze trial data for drug approval

Detailed Explanation of Clinical Trials

• Protocol: A guiding document for SAS programmers and other clinical trial participants.
• Site Selection: Choosing hospitals for trials, often done in multiple centers/countries
• Patient Recruitment: Eligibility criteria based on protocol; inclusion and exclusion factors
• Case Report Form (CRF): Document capturing patient information, including medical history and vital signs

Data Handling in Clinical SAS

• CRO Organizations: Enter data into databases for SAS programmers to analyze
• Editing: Validation checks on data, including alert programming to flag out-of-range values
• Reporting: Generating reports (tables, listings, figures) and submitting to FDA
• Results Meeting: Discussing findings with stakeholders

CDISC, SDTM, ADaM, and TLFs

• CDISC: Clinical Data Interchange Standards Consortium
• SDTM: Study Data Tabulation Model; raw data standards
• ADaM: Analysis Data Model; derived data for analysis
• TLFs: Tables, Listings, Figures; final report for FDA submission
• Standard Compliance: Mandatory for FDA approval

Career Guidance

• Who Can Learn: Any graduates, postgraduates in various scientific and technical fields
• Job Scope: High demand; starting from fresher to experienced professionals
• Salary Insights: Ranges from 3.5 lakhs for freshers to 40 lakhs for highly experienced professionals

Training Details

• Duration: 60 days of training, 1 hour/day
• Class Timing: Monday to Friday (IST)
• Practice: Lifetime access to SAS software and material
• Support: 24/7 live support via WhatsApp, on-job support
• Course Content: Comprehensive training including real-time projects
• Environment: Interaction with trainer, live sessions

Additional Notes

• Importance of Protocol: Essential for understanding clinical trials and programming tasks
• Multi-Center Trials: Necessary for global drug approvals
• CRF to Database: Scanned CRFs converted to digital data for analysis
• Data Entry and Validation: Ensuring accuracy through entry checks and validations
• SAS Programming: Writing programs to generate required reports, ensuring compliance with standards

Conclusion

• Commitment: Attend all sessions, practice regularly
• Demo: Free demonstration available
• Contact: Provided number and website for registration and queries