GCP and the EU Directive on Clinical Trials for Paediatric Research Staff

Level
Foundation

Aims
The aim is to introduce the key principles of GCP, the EU Directive on Clinical Trials and the UK legislation on Clinical Trials, and highlight day to day aspects that are specifically significant to paediatric clinical research.

Learning Outcomes
Following the course, participants will be able to:

• Understand the general principles of GCP and regulatory responsibilities to comply with the EU Directive on Clinical trials and the relevant UK legislation and how these relate to the day to day conduct of paediatric clinical research within Europe
• Understand the guidelines for children’s consent/assent and pharmacovigilance.

Programme
The course will cover the following topics:

• The key elements of GCP & the EU Directive on Clinical Trials
• Current UK regulations for research involving children
• Guidelines for children’s consent /assent
• Pharmacovigilance and safety reporting.

Duration
This is a one day course.

Further Information
This course is for staff involved in paediatric research. It is recommended that this course is attended every two years to ensure research staff are fully up-to-date with the latest regulations. The day will include a combination of presentations, discussions and workshops.

Cancellation Policy
UKCRN courses are offered free of charge to all staff and public and patient representatives working on or associated with the UKCRN portfolio of studies. Networks and host organisations are expected to pay travel, accommodation and other additional expenses incurred by their nominated staff. Failure to take up a pre-booked, confirmed place without giving the necessary notice will incur a £75.00 charge to cover part of the UKCRN Coordinating Centre’s costs. By accepting enrolment on this course, the UKCRN will determine that you are fully aware of the booking and cancellation/non-completion policies, and agree to the terms and conditions contained within these documents