Development of a Clinical Study Report

Introductory Course for Those Who are New to Writing or Reviewing Integrated Clinical Study Reports

This fast-track course will teach you the latest strategies for preparing clear, well-organized, and ICH-compliant clinical study reports.

WHAT YOU WILL LEARN

·          Structure and format of an integrated clinical study report in accordance with ICH guidelines

·          Investigational plan through statistical methodology

·          Study population and protocol deviations

·          Placement and presentation of study information and data in various report sections, including tables, appendices, and supporting documentation

·          Safety and efficacy results

·          Pharmacokinetic and/or pharmacodynamic endpoints

·          Acceptability of abbreviated study reports