Back to Agenda
Part 1 - Purpose and Organization of a Clinical Study Report and Writing the Introduction
Session Chair(s)
Diptee A. Gajjar, PhD
Intercontinental Regulatory Strategy Lead
Bristol-Myers Squibb Company, United States
- Introduction, purpose, and general requirements of a clinical study report
- Clinical study report organization and hints on authorship
- Other types of study reports (abbreviated/synoptic reports)
- Title page, ethics, and study administrative structure
- Introduction and study objectives
- Investigational plan through statistical methodology
- Investigational plan
- Subject selection criteria
Have an account?