Angela Frotzler, PhD MBA (30min) - nothing to disclose
The first part of the workshop will provide a general overview of the benefits and requirements of the ICH GCP E6 (R2) guideline. The emphasis will be on the role and the responsibilities of the sponsor-investigator. The requirements of a research oriented, risk-based quality management system (QMS) and risk-based monitoring will be discussed in the context of feasibility and practicability in the daily clinical routine. The benefits and limitations of standard operation procedures (SOP) or working instructions as tools for quality assurance will be elucidated.

Jörg Krebs, Dr. med. PhD (30 min) - nothing to disclose
The second part of the workshop will aim at providing a deeper insight into the requirements and challenges of data management, data handling and documentation during clinical research, according to the ICH GCP E6 (R2) guideline. The principles and challenges of data management will be discussed on the basis of practical examples. Furthermore, reporting requirements during clinical trials will be discussed.

Andrea Prusse, Study Coordinator (30 min) - nothing to disclose
In the third part, we will focus on practical issues during the implementation of the ICH GCP E6 (R2) guideline in clinical trials. On the basis of an exemplary multicenter, high-risk, interventional clinical trial with spinal cord injury individuals, diverse aspects and challenges in the implementation of GCP will be presented and discussed. A special focus will lay on the feasibility and hurdles of implementing GCP guidelines. Realizable solutions for GCP-requirements will be presented.