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 plans using 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
Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.
Event Code: 12408
Organized by:
DIA
Invited Speakers:
Patricia A. Matone, PhD President Scientific Information Services LLC, United States