GCP For The CRA
Course Title: GCP For The CRA
Time: 08h00 – 17h00
Cost: R5186.00 incl. vat
Learning Plan GCP for the Clinical Research Associate (3-day course)
By the end of the course, the learners will be able to:
1. Discuss the responsibilities of the monitor as determined in ICH-GCP
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 topics 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. In workshop activity, write a protocol summary as per workshop guideline.
10. Provide an explanation surrounding the history of good clinical practice and the principles as outlined in the ICH-GCP guideline
11. Provide a background to research ethics.
12. Discuss the basic principles of the Declaration of Helsinki
13. Define an ethics committee and discuss the responsibilities, composition, function and operations of an ethics committee
14. Define a regulatory authority and discuss the responsibilities of the South African regulatory authority, composition, function and operations.
15. Provide a background to drawing up financial budgets and investigator/site contracts
16. In workshop activity, draw up the financial budget as per workshop guideline.
17. Discuss the principles of the informed consent as described in the Declaration of Helsinki and ICH-GCP guidelines
18. Discuss the new informed consent requirements and the South African requirements
19. Discuss informed consent requirements for special cases: children, psychiatric subjects, mentally ill subjects, emergency care subjects
20. Identify the key elements of the consent form
21. Debate and identify strategies of managing informed consent in special cases.
22. In workshop activity, calculate the readability of the training informed consent document.
23. Explain the process of site selection, discuss the preparatory steps, conduct and evaluation of the site and site staff, key considerations for the sponsor and investigator site in site selection
24. Explain the process of verification of patient estimates
25. In workshop activity, discuss and identify the strengths, weaknesses, opportunities and strengths of proposed clinical trial sites
26. Define essential documents
27. Identify and file essential documents
28. Explain the process of site initiation, preparation, conduct and topics for discussion
29. Discuss the ethical issues governing patient recruitment and retention
30. Determine patient recruitment strategies
31. Determine the challenges in recruiting clinical trial patients
32. Discuss the management of subjects in a clinical trial
33. Explain the objectives of monitoring visits
34. Discuss source data verification at the research site
35. Identify key source data requirements
36. Identify monitoring tools required for a monitoring visit
37. In workshop activity, demonstrate ability to monitor source documents and case report form
38. Explain the definition of an investigational product.
39. Discuss the requirements for investigational product packaging, labelling, storage, dispensing, reconciliation and return
40. Discuss drug accountability at the site
41. Provide a background to good laboratory practice.
42. Define adverse events, adverse drug reactions, serious adverse events.
43. Differentiate between expected and unexpected adverse events
44. Differentiate between seriousness and event intensity
45. Discuss assessment of causality of investigational product to adverse event
46. Discuss investigator and sponsor reporting obligations
47. Demonstrate an understanding of adverse event management in workshop activity case studies
48. Ensure a understanding of data management process
49. Explain the process of site close-out, preparation and conduct
50. Provide a background to scientific fraud and misconduct
51. Provide a background to auditing
52. Discuss audit preparation and steps during the audit process
53. Provide a background to soft skills: problem solving, motivation, time management, assertiveness, conflict resolution, negotiation, communication
Dates
4-6 March 2009: Johannesburg, TBC
26-28 August 2009: Johannesburg, 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