Good Documentation Practices

Build documentation you can defend.

Every clinical trial depends on documentation. Not just what is recorded, but how it is recorded determines whether your data can be trusted. This session breaks down Good Documentation Practices (GDP) into clear, practical actions you can apply at the site level. You will see how everyday documentation decisions directly impact participant safety, regulatory compliance, and data integrity. We walk through ALCOA+ principles in a way that connects to real work. How you write, correct, sign, and maintain records determines whether your documentation holds up under review. You will also review side-by-side examples of weak versus compliant documentation so you can recognize risks before they become findings. This session covers: • What GDP is and why it matters in clinical research • How ALCOA+ applies to both paper and electronic records • Best practices for recording data, signatures, and corrections • Common documentation mistakes and how to prevent them • The real impact of poor documentation, including regulatory findings and trial risk If you have ever questioned whether your documentation would stand up to an audit, this session gives you a clear answer and a path forward.