Performance of clinical trials according to the Good Clinical Practice (GCP) standard has been introduced as a European regulatory requirement for clinical trials with medicines but as this is a globally agreed best practice standard for clinical research involving human subjects, it is an ethical obligation for clinical researchers to apply this standard to all type of studies to ensure optimal protection of participants and generation of reliable results. It is the basis for enabling funding, acceptance of publications and for patients’ access to new treatments. This standard has implications for all stakeholders and processes in clinical trials. However, despite overall commitment and best intentions to apply to these requirements, monitoring, audits and inspections regularly find deficiencies of different levels of severity.
In this interactive 3 lunchtime lectures current experience and requirements of GCP-conform set-up and performance of clinical studies will be presented, practical implications and examples discussed and pragmatic solutions for your daily practice elaborated.
for articles/videos/studies
Healthcare professionals who wish to be part of a unique network, providing access to up-to-date, accurate and validated information about clinical research.
Investigators and study staff who wish to be part of a unique network, in order to stay abreast of clinical trials taking place in Luxembourg and who are willing to further develop their competencies.
