Addressing ongoing GCP

Good Clinical Practice (GCP) is the international standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that involves humans. It also serves to protect the rights, integrity, safety and confidentiality of trial subjects. The principles of GCP have their origins in the World Medical Association’s Declaration of Helsinki, first published in 1964.

Why bring the GCP programme to your organisation

Today it is expected that all staff involved in clinical research should have GCP training and this training must be relevant and appropriate to the role that each staff member has in the clinical trial.

  • Pharmaceutical and Biotech companies expect to see investigative staff GCP trained as a matter of course and this training should be updated regularly to ensure knowledge remains current.

  • Increasingly FDA, MHRA and pharmaceutical-driven audits and inspections are looking for ongoing evidence that lead investigators and research staff are able to demonstrate ongoing GCP awareness and understanding.

Who you will learn with

Sophie Mepham

With a PhD in Immuno-Oncology since 2001, I've played key roles in clinical trials in the UK and Australia, from the NHS to leadership positions at Peter Mac, GenesisCare, and my current role as Global Executive Manager for Research at Icon Group. Trained as a GCP facilitator in 2011, I've taught GCP and led successful GCP-compliance inspections in the UK and Australia. Holding a Cert IV in Training and Assessment, I contribute to the education and development of individuals in clinical research.

Want to bring this course to your organisation?

We have bundled all our courses so you can provide training to your staff