Clinical Trial Reporting

Course Overview

This course focuses on the end-to-end process of clinical trial reporting, covering the generation of Tables, Listings, and Figures (TLFs) and their integration into Clinical Study Reports (CSRs). You’ll learn how to organize, summarize, and present clinical data in a regulatory-compliant format, following CDISC and ICH guidelines.

Learning Objectives

• Understand the components and workflow of clinical trial reporting.

• Learn to generate and validate TLFs using SAS programming.

• Link TLFs with SDTM and ADaM datasets for traceability.

• Comply with global reporting standards (CDISC, ICH E3, FDA, EMA).

• Develop automated and reproducible reporting pipelines.

Course Modules

Module 1: Introduction to Clinical Trial Reporting

• Overview of CSR and its regulatory context

• Structure of Tables, Listings, and Figures (TLFs)

• Data flow from SDTM → ADaM → TLFs

Module 2: Table Generation and Formatting

• Generating summary tables for demographics and efficacy

• Using PROC REPORT and PROC TABULATE

• Formatting outputs for CSR integration

Module 3: Listings and Data Validation

• Creating patient-level data listings

• Ensuring consistency between datasets and outputs

• Common QC procedures for listings

Module 4: Figure Production and Visualization

• Creating visual summaries using PROC SGPLOT

• Standard safety and efficacy visualizations

• Exporting publication-ready figures

Module 5: Automation and QC

• Macro-based automation for multiple outputs

• Traceability and audit readiness

• Reproducible workflow management

Module 6: Final Report Integration

• Preparing outputs for CSR submission

• Using templates and cross-referencing

• Best practices for documentation and traceability

Key Features

• 📊 Hands-on exercises with real clinical trial datasets

• 💡 Focus on TLF design, QC, and submission readiness

• 🧭 Step-by-step guidance for CSR report preparation

• ✅ Practical knowledge applicable to regulatory submissions

Who Should Attend

• SAS programmers involved in clinical reporting

• Biostatisticians preparing regulatory deliverables

• Clinical data analysts and statisticians

• Anyone aiming to master end-to-end reporting workflows

Duration

Approx. 10 hours (including exercises and case-based projects)

What You’ll Gain

By the end of this course, you will have the skills to design, generate, and validate comprehensive clinical trial reports that meet international regulatory standards, positioning you for advanced roles in biostatistics and clinical programming.