Date(s) And Time(s):
Apr 16 2010 8:00AM - Apr 16 2010 4:00PM
Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509
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
For detailed program information including faculty and topics, please contact: