Study Schedule

Study Schedule (CRA)

  1. Intro – Why do I want to become a CRA?, 6,
  2. Research and development of new pharmaceuticals, 6,
  3. Principles of clinical pharmacology, 6,
  4. Principles of conducting a clinical trial, 12,
  5. Regulatory affairs in clinical trials, 12,
  6. Good Clinical Practice, 12,
  7. Biology research ethics, 2,
  8. Documentation, 4,
  9. Monitoring, 24,
  10. Fraud and mistake, 2,
  11. Quality control, 4,
  12. Principles of project management, 12,
  13. Statistics and data processing,12,
  14. Monitoring of drug safety and pharmacovigilance in clinical research, 14,
  15. Therapy; therapeutic areas; biology of disease, 4,
  16. English language and business communication, 30,
  17. IT in clinical research, 30,
  18. Practical training, 60.

1stSemester

1. Intro – The role of CRA in clinical trials

2. Research and development of new pharmaceuticals

3. Principles of clinical pharmacology

4. Regulatory affairs in clinical trials

5. Regulatory affairs in clinical trials II

6. Principles of conducting a clinical trial

7. Ethics

7a. Documentation

8. Soft Skills

9. Principles of Good Clinical Practice

10. Monitoring I – Feasibility; site evaluation

11. Monitoring II – Site initiation; monitoring visit

12. Monitoring III – Monitoring visit; site close-out

13. Monitoring IV – Study close-out; archiving

2ndSemester

1. Mistake and fraud

1a. Control and compliance

2. Principles of project management I

3. Principles of project management II

4. Statistics and data processing I

5. Statistics and data processing II

6. Pharmacovigilance I

7. Pharmacovigilance II

8. Pharmacovigilance III

8a. Therapy and principles

9. Test, 4 classes

10-13. Practical training, 60 classes

 

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