🇬🇧 Interactive Training in Applied GCP – Special focus on IT Tools and Electronic Data in Clinical Research

• Clinical and Epidemiological Investigation Center (CIEC)

Effective Clinical Research relies on a growing variety of IT tools and electronic data for most processes involved. IT Tools (computerised systems) and electronic data are an integral part of the Clinical Research project scope and are subject to the quality framework for Clinical Studies.

How can we apply Good Clinical Practice (GCP) principles to ensure reliable protection of study participants, including their rights and the integrity of research data, even when using rapidly evolving IT Tools for conducting Clinical Trials?

How can we ensure that the electronic data used, which is generated, handled, and stored within computerised systems, are reliable, and their integrity can be demonstrated to auditors and inspectors? The amended ICH-GCP(R2) has provided some clarity on computer system validation, electronic data and SOP requirements. For a deeper understanding the European Medicines Agency (EMA) has released the “Guideline on computerised systems and electronic data in clinical trials” that came into force in September 2023.

In this interactive advanced GCP Training, we will present the current quality framework for electronic data and computerised systems in clinical trials and discuss the resulting practical issues, hurdles, risks, and conflicts in their development and application.

Important Information

• A GCP certificate will be delivered upon participation & passing of the final test (Otherwise certificate of attendance)
• A GCP certificate is mandatory for all persons working within studies including human subjects and is valid for a period of 2 years.

AGENDA

Trainers

Partner

Information: tania.zamboni@lih.lu