Clinical Reporting with R: Raw Data to SDTM and ADaM

Navigating the transition from raw clinical trial data to submission-ready reports can be challenging without a clear understanding of industry standards. This course provides a structured, text-based introduction to clinical data reporting using the R programming language. You will learn how to map raw Case Report Form (CRF) and non-CRF data into standardized SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) formats. By reading through practical explanations and reviewing clear code examples, you will understand how to build reproducible clinical pipelines that align with modern biostatistics workflows. What you'll learn: - Understand the core architecture of the clinical data flow from raw data sources to final reports. - Map raw clinical trial data to standardized SDTM domains using R. - Derive analysis-ready datasets by building compliant ADaM structures. - Generate clinical tables, listings, and figures (TLFs) using modern R reporting packages. - Apply modern reproducible reporting principles with R Markdown and Quarto. - Implement best practices for data validation and traceability in clinical programming. The course begins with foundational concepts of clinical trials and CDISC standards before moving into step-by-step code walkthroughs for data transformation. You will progress from raw data ingestion to creating final compliant outputs using industry-aligned R packages. This course is designed for aspiring clinical programmers, biostatisticians, and data analysts who want to learn clinical reporting standards. A basic familiarity with R is helpful, but no prior experience with clinical trials or CDISC standards is required. Start your journey toward mastering clinical data pipelines today.