Drug Information Association, Inc. , Horsham PA USA
Apr 16 2010
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
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