Understanding GCP: education, training and experience

1. Understanding GCP:education, training and experience Barbara Farrell (UKTMN) Sarah Meredith (UKCRC)

2. What is GCP? Good Clinical Practice (GCP) is defined as a ‘standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected’ (ICH GCP)

3. EU GCP Directive • Released 8th April 2005 • Deadlines for implementation • Directive came into force 28th April 2005 • UK law by January 2006 • UK regulations may need to be updated to bring them in line with the GCP Directive

4. Principles of GCP (1) • Rights, safety & well being of subjects prevail over interests of science and society • Individuals involved in trial should be qualified by education, training and experience to perform his/her tasks • Trials shall be scientifically sound and guided by ethical principles in all their aspects • Necessary procedures to secure the quality of every aspect of the trial shall be complied with

5. Principles of GCP (2) • Available non-clinical and clinical information on an IMP shall be adequate to support the trial • Conducted according to Helsinki Declaration (1996) • Protocol shall provide inclusion and exclusion criteria, monitoring and publication policy • Investigator/sponsor shall consider all relevant guidance • Information recorded, handled and stored to allow accurate reporting, interpretation and verification and confidentiality of subjects’ records

6. GCP compliance • ICH GCP section 5.18.3 allows individual researchers to assess the needs of their trial and apply GCP appropriately ‘central monitoring in conjunction with procedures such as investigators’ training and meetings and extensive written guidance can assure appropriate conduct of the trial in accordance with GCP.’ • On-site monitoring not required

7. GCP for trialist: exercise • Multi-centre open 2x2 factorial randomised controlled trial of aspirin and heparin in acute ischaemic stroke, with an additional randomisation of dose in 2 arms • Sites with track record of conducting trials • CT scan to confirm eligibility • Open label drug dispensed on the ward • Data collected centrally

8. Who must comply with GCP? • All individuals involved in any aspect of the trial must be suitably ‘qualified’ to be able to comply with GCP. • Sponsors/CIs are responsible for ensuring that all staff are able to comply with GCP.

9. What counts as ‘qualified’? • Education • Training • Experience There is no GCP ‘qualification’

10. Education Individuals must be educated to be able to competently perform their specific trial task. • Clinicians must be clinically qualified • Statisticians must be qualified • Managers must be appropriately educated

11. Training There are variety of courses and seminars currently available • Employer induction courses • Industry courses • E-learning (Institute of Clinical Research) • Private courses (usually run by freelance consultant) • Host institution courses • Trial specific workshops • Investigators meetings

12. Experience On-the-job learning • Discovering what is required • Doing the job (sometimes wrongly) • Cascading information and knowledge through teams/units • Talking to other trialists

13. Rationale and documentation • Describe the rationale for the methods of GCP ‘training’ used in the trial • Document courses/seminars/meetings attended by staff on a training file • Keep it up to date

14. GCP ‘training’ As there is no formal qualification it is essential to keep up to date records of training. Documentation, documentation, Documentation . . . .