GCP Workshop (Investigator Site Team)
Course Title: GCP workshop, 2 days
Time: 08h00 – 17h00
Cost: R2600 (incl VAT)
Learning Plan This is a basic GCP course focused for new entrants in the clinical research field.
By the end of the course, the learners will be able to:
1. Provide an explanation surrounding the history of good clinical practice and the principles as outlined in the ICH-GCP guideline
2. Define what a clinical trial is
3. Differentiate between the phases of clinical trials
4. Identify and explain the different features of a clinical trial
5. Define what an investigator’s brochure is.
6. Explain the purpose of an investigator’s brochure and list the key content topic in an investigator’s brochure
7. Define what a protocol is
8. Explain the function of a protocol and list the key content topics in a protocol
9. Provide a background to research ethics.
10. Discuss the basic principles of the Declaration of Helsinki
11. Define an ethics committee and discuss the responsibilities, composition, function and operations of an ethics committee
12. Define a regulatory authority and discuss the responsibilities of the South African regulatory authority, composition, function and operations.
13. Debate the ethical issues in a proposed clinical trial using the South African Clinical Trials Guidelines and the Declaration of Helsinki
14. Explain the process of site selection, discuss the key considerations for the sponsor and investigator site in site selection
15. Discuss and identify the strengths, weaknesses, opportunities and strengths of proposed clinical trial sites
16. Discuss the principles of the informed consent as described in the Declaration of Helsinki and ICH-GCP guidelines
17. Discuss the new informed consent requirements and the South African requirements
18. Discuss informed consent requirements for special cases: children, psychiatric subjects, mentally ill subjects, emergency care subjects
19. Identify the key elements of the consent form
20. Debate and identify strategies of managing informed consent in special cases.
21. Provide a background to organisation of the clinical trial site infrastructure to successfully conduct a clinical trial
22. Debate and discuss the ethical issues governing patient recruitment and retention
23. Determine patient recruitment strategies
24. Determine the challenges in recruiting clinical trial patients
25. Discuss the management of subjects in a clinical trial
26. Discuss the investigator responsibilities associated with document management
27. Demonstrate documentation of key source data requirements
28. Demonstrate ability in completion of case report form
29. Ensure a understanding of data management process
30. Explain the definition of an investigational product.
31. Discuss the requirements for investigational product packaging, labelling, storage, dispensing, reconciliation and return
32. Discuss good laboratory practice.
33. Define essential documents
34. Identify and file essential documents
35. Define adverse events, adverse drug reactions, serious adverse events.
36. Differentiate between expected and unexpected adverse events
37. Differentiate between seriousness and event intensity
38. Discuss assessment of causality of investigational product to adverse event
39. Discuss investigator and sponsor reporting obligations
40. Demonstrate an understanding of adverse event management in workshop activity case studies
41. Provide a background to scientific fraud and misconduct
42. Provide a background to auditing
43. Discuss audit preparation and steps during the audit process
Dates
13-14 February 2009: Johannesburg, TBC
10-11 July 2009: Pretoria, TBC
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