Development of a Clinical Study Report

Venue: Gaylord National Hotel and Convention Center

Location: National Harbor, Maryland, United States

Event Date/Time: Feb 14, 2011 End Date/Time: Feb 14, 2011
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Description

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


Event Code:
11405

Venue