Development of a Clinical Study Report

This fast-track course covers the latest strategies for preparing clear, well-organized, and International Conference on Harmonisation (ICH)–compliant clinical study reports. Topics include investigational plans using statistical methodology, study population and protocol deviations, and safety and efficacy results.

• 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

• Clinical research and development professionals
• Medical writers
• Regulatory affairs personnel
• Biostatisticians
• Clinical operations professionals

Participants who complete this training should be able to:

• Recognize key regulatory requirements for integrated and abbreviated clinical study reports
• Explain the format and structure of a clinical study report
• Describe the relationship of the clinical study report to the clinical study protocol
• Discuss various approaches to solving problems related to preparation, protocols, patient disposition, compliance, and changes to statistical methods
• Develop a comprehensive and easily reviewable clinical study report