How to conduct a clinical trial in accordance with good clinical practice (GCP)

Only for EKFZ Academy members

Speakers

Dr. Karsten Gavenis, Dr. Thomas Asendorf, Dr. Florian Walker (Clinical Trial Unit UMG)

Krishyanthy Sritharen (Fraunhofer Institute for Translational Medicine and Pharmacology ITMP)

Description

• The workshop “How to conduct a clinical trial in accordance with good clinical practice” provides an overview of the requirements for clinical trials. It discusses the classification of different types of trials, their regulatory differences, and the impact on the respective trial design and study conduct. Important aspects of planning and implementation are discussed, such as the statistical aspects of case number planning, power calculation, and outcome, as well as endpoint determination. Regarding study conduct, emphasis is placed on the most important points of preparation and practical implementation, including pitfalls.