CDASH SAE E2B

Purpose: to educate those involved in defining, capturing and reporting clinical research safety data about the larger safety landscape, the role of safety data, and how regular AE data collection can be harmonized with SAE reporting to maximize efficiency.

 

Overview of Pharmacovigilence

  • Clinical research overview
  • Ethical protections in clinical research
  • Drug safety life cycle
  • Basics of pharmacovigilance
  • Signal detection

Safety during drug development

  • Safety data acquisition and workflow
  • Overview AE and SAE data capture
  • Introduction to AE CRFs and the SAE Form
  • Site, sponsor and regulatory reporting of (serious) adverse events

The data in Pharmacovigilence and Safety Reporting

  • Introduction to the CDISC AE standard: purpose, scope, benefits
  • Data defined in the CDASH SAE Supplement
  • General technical characteristics of CDASH/SDTM SAE and E2B variable names
  • An SAE Form: compliant with E2B and ICSR (Individual Case Safety Report) requirements

Target audience:

  • Statisticians
  • Clinical data programmers
  • Clinical data managers
  • Independent investigators
  • Pharmacovigilence specialists
  • Anyone who needs to understand the landscape of safety data and reporting in clinical research before and after product approval