This module is introduced by Sebastian Marciano, Head of Hepatology at Hospital Italiano de Buenos Aires, Argentina; Cristina Sánchez-Garrido, Head of the Data Management Center at EF CLIF, Spain; and Frank Uschner, Physician at University Hospital Münster, Germany.

 

They will guide you through the essential operational and regulatory aspects of implementing prospective clinical research. The module covers ethical and regulatory requirements, data protection, study registration, site selection and initiation, electronic case report forms, and the role of biobanking in clinical research, providing the practical foundations needed to conduct high-quality, compliant clinical studies.

 

Upon completing Module 3, students will be able to:

• Anticipate and implement appropriate ethical oversight.
• Ensure compliance with data protection and confidentiality standards.
• Interpret regulatory requirements and account for regional variability.
• Understand the importance of study preregistration, and select appropriate platforms and timing.
• Plan effective site selection and study start-up strategies.
• Incorporate biobanking and electronic data capture tools (i.e., electronic case report forms) into study planning and conduct.