Clinical SAS

This course covers the end-to-end clinical data flow, including CDISC standards (SDTM & ADaM), CRF annotation, TFL programming, and clinical trial documentation. Participants will gain practical experience in SAS Base & Advanced Programming, data handling, and statistical output generation for regulatory submissions. The course also includes a dedicated project module, live training, case studies, and official SAS training materials.

Key Learning Modules:

1. Introduction to Clinical SAS & CDISC Project (Optional Module)

✔ Understanding CDISC Standards – Overview of SDTM, ADaM, and TFL programming

✔ End-to-End Clinical Data Flow – Data collection to regulatory submission

2. CRF Annotation Overview

✔ Understanding Case Report Forms (CRFs) – Mapping clinical data to CDISC standards

3. Clinical Research Documentation

✔ Reviewing Protocol, SAP & Mock Shells – Aligning programming with study objectives

4. SDTM (Study Data Tabulation Model) Domain Programming

✔ Building SDTM Datasets: • Core Domains: TA, TE, TI, TS, TV, DM, DS, EX, LB, CM, AE, EG • Supplementary Domains: SUPPDM

5. ADaM (Analysis Data Model) Programming

✔ Developing ADaM Datasets for Statistical Analysis: • Key Domains: ADAE, ADCM, ADSL, ADLB

6. TFL (Tables, Figures & Listings) Programming

✔ Generating Clinical Study Outputs for Regulatory Submission: • Safety Listings – Subject-level data representation • Safety Tables – Summary statistics for clinical data • Safety Graphs – Visualizing clinical trial results

7. SAS Base & Advanced Programming (45 Days)

✔ Daily 1-Hour Sessions Covering: • Data manipulation, statistical procedures, and macro programming • Best practices for clinical data transformation and analysis

8. Hands-On Project (15 Days)

✔ Practical Case Study with Weekly Support Sessions – Working on assigned deliverables

9. Study Materials & Live Training Support

✔ Official SAS Training Modules – Industry-standard study materials

✔ Daily Email Handouts & Case Studies – Reinforcing key learning points

✔ Recorded Live Sessions – Access to training materials anytime Who Should Attend?

✅ SAS Programmers & Data Analysts in clinical research

✅ Biostatisticians & Clinical Data Managers handling trial data

✅ Clinical Research Professionals & Medical Writers involved in data interpretation

✅ Life Sciences, Pharmacy, and Healthcare Graduates seeking a career in Clinical SAS.