Event Detail
Development of a Clinical Study Report
April 16, 2010
- Horsham PA UNITED STATES
Drug Information Association, Inc.
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