This course provides a comprehensive introduction to clinical trials, emphasizing key concepts in clinical research, the role of CDISC in data standardization, and the development of SDTM (Study Data Tabulation Model) domains using SAS programming. Through synthetic raw data, hands-on demonstrations, and practical exercises, you'll learn how to effectively use SAS for managing and analyzing clinical trial data.
Learn How To
Understand the steps involved in the FDA drug approval process. Navigate and utilize CDISC and clinical research documentation for data management and submission. Prepare SDTM domains for regulatory submission to ensure compliance with industry standards. Navigate the SDTM Implementation Guide (SDTMIG). Decipher, create, and map SDTM variables. Use the SQL procedure to create datasets.Who Should Attend
This course is specifically designed for professionals working in clinical trials, clinical data management, and biostatistics, who want to enhance their skills in clinical data standardization, SDTM domain creation, and SAS programming.
Prerequisites
SAS Programming 1: Essentials (required). SAS Programming 2: Data Manipulation Techniques (recommended)Course Outline
Introduction
Introduction to Clinical Trials ResearchIntroduction to Clinical Data Interchange Standards Consortium (CDISC)Building SDTM Domains with SAS ProgrammingIntroduction to the Study Data Tabulation Model Implementation Guide (SDTMIG) Trial Design Domains Demographics (DM) Domain Supplemental (SUPP) Domain Exposure (EX) and Exposure as Collected (EC) Domains Adverse Events (AE) Domain Laboratory Test Results (LB) Domain Custom Domain 
