Development of a Clinical Study Report

Part 1:
Purpose and Organization of a Clinical Study Report and Writing the Introduction
•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

Questions/Answers/Exercise