The entire programme consists of two, stand alone courses. However participants may feel that their role requires only completion of Part 1 of the programme. Part 2 is more relevant to those involved in the design and management of clinical studies.
Part 1 is a 2.5-day course covering the fundamentals of clinical research (basic course). Participants who have attended this course are eligible to sit an independently marked and validated examination leading to the Certificate in Basic Clinical Research & GCP Competence.
Programme participants may then attend the 2-day Part 2 applied course. This focuses on project management and GCP-problem solving skills. Participants who attend the Part 1 course, pass the Part 1 exam and attend the Part 2 course are eligible to sit the examination for Certificate in Clinical Research & GCP. Examinations are undertaken at a time and location to suit the participant. More details of the courses may be found below.
This is a 2.5 day basic “fact giving” course which provides a comprehensive introduction to the fundamentals of clinical research and GCP. Little or no experience is necessary. However, those with more experience will still find the course informative and brings together and consolidates knowledge already acquired. The course is mandatory for those wishing to attain certification. The course qualified for the independently validated examination leading to the Part 1 Cert CRGCP “Certificate of Basic Competence Clinical Research & GCP”. The course is also open to participants who do not wish to take the examinations or attain certification.
Educational objectives and course content
This 2-day applied course covers advanced and practical topics not covered in Part 1. It is dominated by group work and gives participants the chance to develop their trial design and project management skills as well as promoting clinical research problem solving skills. General awareness information is provided about the new European requirements for interventional trials in humans. Participants who have passed the basic course examination and have attended this course are eligible to sit the optional examination for the “Certificate in Clinical Research & GCP”. The course is also open to participants who do not wish to take the examinations or attain certification.
Educational objectives and course content