The Academy is able to provide a 1-day training course for investigator site staff on an in-house or sponsored basis. We are also able to provide short presentations or half-day courses. The full day course provides training and optional examination for the Certificate in Study Site GCP. PC-based training is also available – this enables sponsors to train all of their study site personnel without the need to set up a formal course.
The full 1-day course aims to provide information on the investigator's most important GCP responsibilities. It will provide awareness of the following topics
The Academy, in conjunction with its sister company Canary Ltd, has
developed a four-part PC based training programme for investigators. The
programme covers the most important GCP responsibilities of study site
personnel.
Training can be undertaken at a place, pace and time to suit the
individual. It is an ideal introduction to GCP for trial staff and for
those unable to attend a formal course.
The four modules are provided on CD for loading on to a PC. A notes
manual is provided. The first three parts are separate 12 minute
presentations delivered using PowerPoint shows, written and narrated by
Professor David Hutchinson.
Part1: GCP fundamentals -- what it is, who it affects, ICH GCP basics
and the importance of having and following SOPs
Part 2: GCP responsibilities, site suitability and knowledge, ethics and
consent of subjects
Part 3: data collection, safety reporting and trial documentation
Part 4 is an interactive quiz that tests GCP knowledge. This can linked
to an email address for review of test scores and certification by the
Academy.
For further information, contact the Academy.