The training covers topics such as the key principles of the ICH-GCP E6 guideline, the role of ethics committees, data management and study documentation. In addition, we provide a historical overview of the development of international guidelines of clinical research, a general introduction to the phases of drug development and demonstrate the importance of quality assurance and quality control.
The course consists of presentations, enriched with practical examples, supplemented with interactive exercises and case studies. Prior to the course, participants will be expected to have read the “ICH Harmonised Guideline – Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)” and the “Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects” (Version October 2013, Fortaleza) (appr. 3 hours).