QUESTIONSDevelopment 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 |
Report as SpamDescription
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
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
