SAS Clinical

Course Overview

Course Curriculum

Week 1: Foundations of Clinical Domain and SAS Programming

  • Overview of Clinical Domain: Understanding the significance of clinical research in healthcare and pharmaceutical industries.
  • Clinical Trial Phases: Exploring the sequential stages of clinical trials, from initial testing to post-market surveillance.
  • Clinical Trial Designs: Delving into various methodologies employed in clinical research, such as randomized controlled trials and cross-over trials.
  • Regulatory Guidelines: Getting acquainted with regulatory standards set by bodies like the International Council for Harmonisation (ICH) and the importance of adherence to Good Clinical Practice (GCP) guidelines.
  • Study Documentation: An introduction to essential documents like annotated Case Report Forms (aCRF), Protocols, Statistical Analysis Plans (SAP), and Specifications.

Week 2: CDISC Standards and Safety Domains

Week 3: ADAM Model Implementation and Dataset Development

Week 4: Advanced ADAM Implementation and Dataset Development

Week 5: Report Generation and TLFs Development

Week 6: Review, Discussion, and Mock Interviews

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