Development of a Clinical Study Report

Part 2:
Writing the Investigational Plan and Analysis Approach, Creating Effective Data Displays, and Developing the Study Population and Efficacy Results Sections
•Investigational plan through statistical methodology (continued)
•Study treatment and prior and concomitant medication
•Study evaluations
•Data quality assurance and statistical methodology
•Effective data presentations
•Study population and protocol deviations
•Efficacy results

Questions/Answers/Exercise