KHP CTO: Good Clinical Practice and the Medicines for Human Use (Clinical Trials) Regulations (CTIMPs)

Event Description

This half-day course will provide those staff and students involved in the conduct of CTIMPs an informal but intensive overview of the fundamentals of Good Clinical Practice. The training is based on the principles of GCP and The Medicines for Human Use (Clinical Trials) Regulations SI. 2004/1031 and subsequent amendments, which have transposed the EU Clinical Trials and Good Clinical Practice Directives into UK law.

By the end of this course you will be able to:

• Understand the evolution of GCP including the principles of GCP, the fundamentals of the EU Clinical Trials Directive and the implementing Regulations
• Formulate strategies for incorporating the principles of GCP at the sponsor/trial site
• Be aware of the changes to the ethics process and the definition and responsibilities of the Sponsor and Investigator
• Understand the requirements for informed consent and safety reporting
• Define an Essential Document and understand the requirements for clinical trial documentation and data quality at the trial site
• Understand what an auditor/MHRA inspector will look for when visiting a site

Accreditation:

This course has been accredited 4 CPD points from the Royal College of Physicians.