GCP Training for Investigator Sites

Klinikos routinely conducts GCP courses for Clinical Investigator Site Teams. The training is of particular relevance to Principal Investigators, Co-Investigators, Research Fellows, Study Nurses, Study co-ordinators and Pharmacy personnel.

Klinikos has been running GCP courses for 15 years but more importantly we concentrate on the practical issues of running studies and how best to interact with pharmaceutical research personnel so that the site can become a preferred provider for site recruitment.



Using case studies and group exercises, this 1 day course targets real issues and problems that study site staff deal with managing a clinical trial where the Sponsor is a commercial company or an NHS Trust/Board.

Topics covered in presentation and interactively:

• Investigator and study team responsibilities
• Adverse event reporting
• Source document verification
• CRF Completion (hardcopy/EDC)
• Informed Consent
• Investigator Site File Management

This course is not passive and allows the audience to participate in exercises which they can relate to in their own studies emphasising key points when it comes to enrolling actual patients into a clinical trial.

So many NHS personnel feel they are not properly prepared when they undertake research to fully understand the legal implications of patient recruitment into studies which involve a investigational medicinal product (IMP).

Often the comment after the course is “I wish I had known... or been aware of... these issues before starting my own or commercial project”

Klinikos guarantees that this course will make participants much more aware of their responsibilities and duties in dealing with trial subjects and make study team members more confident in dealing with Sponsors.