This on demand training will take approximately 6 hours to complete.
This fast-track online course is designed for professionals new to clinical development and Clinical Study Report preparation. The Clinical Study Reports for submission to the Health Authorities are required to be in compliance with the International Conference on Harmonization (ICH) standards and must meet high quality standards so that it provides most concise yet comprehensive summary of the study. The course will provide latest strategies for preparing such clear, well organized, ICH-compliant Clinical Study Reports in a most efficient way.
Course Level: Beginner
- Structure and format of a 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
Who should attend?
- Medical writers
- Clinical research and development professionals
- Regulatory affairs personnel
- Clinical operations professionals
At the completion of this activity, participants 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 address issues related to patient disposition, compliance, and statistical methods in the clinical study report
- Develop a comprehensive and easily reviewable clinical study report