GCP workshop, 1 day
Course Title: GCP Workshop (Investigator Site Team) (1 day)
Time: 08h00 – 16h15
Cost: R1300 (incl VAT)
Learning Plan Refresher GCP (1-day course)
Learner selection criteria:
The learner should have at least 2 years of clinical trial experience or previously attended a GCP training course. By the end of the course, the learners will be able to:
1. Provide an explanation surrounding the history and development of good clinical practice and the principles as outlined in the ICH-GCP guideline
2. Discuss the principles of the Declaration of Helsinki
3. Provide a background to the clinical trial guidelines of South Africa
4. Provide a background to FDA regulations on clinical trials
5. Provide a background to recent global and local regulatory updates
6. Provide a background to new South African regulations and guidelines governing clinical research
7. Discuss the documentation of key source data requirements
8. Discuss the management of electronic source
9. Ensure a understanding of data management process
10. Define essential documents
11. Identify and file essential documents
12. Discuss the principles of the informed consent as described in the Declaration of Helsinki and ICH-GCP guidelines
13. Discuss the new informed consent requirements and the South African requirements
14. Discuss informed consent requirements for special cases: children, psychiatric subjects, mentally ill subjects, emergency care subjects
15. Provide a background to clinical trial insurance with respect to sources of liability, South African law, scope of liability, claims, ABPI guidelines
16. Demonstrate an understanding of pre-study, initiation, routine monitoring and close out visit requirements
17. Discuss the requirements for investigational product packaging, labelling, storage, dispensing, reconciliation and return
18. Define adverse events, adverse drug reactions, serious adverse events.
19. Differentiate between expected and unexpected adverse events
20. Differentiate between seriousness and event intensity
21. Discuss assessment of causality of investigational product to adverse event
22. Discuss investigator and sponsor reporting obligations
23. Demonstrate an understanding of adverse event management in workshop activity case studies
24. Provide a background to scientific fraud and misconduct
25. Provide a background to auditing
26. Discuss audit preparation and steps during the audit process
Dates
17 April 2009: Pretoria, TBC
19 June 2009: Johannesburg, TBC
5 August 2009: Pretoria, TBC
7 August 2009: Johannesburg, TBC
16 October 2009: Johannesburg, TBC
AGCP will conduct 1 day GCP training at investigator meetings – for more information, please contact Savi Chetty-Tulsee.
For more information on the courses and course bookings contact
Johannesburg: Savi Chetty-Tulsee 082 654 8395 or savi@agcp.co.za
Durban courses on a need basis only: Savi Chetty-Tulsee 082 654 8395 or savi@agcp.co.za
Courses for Cape Town on a need basis only: Fathima Amod 079 496 2814 or fathima@agcp.co.za