Quick Guide to Good Clinical Practice

1. Clinical Trials: Historical Aspects and Importance and New Drug Developments
Cemal Cingi, Nuray Bayar Muluk

2. The Definition of GCP
Cemal Cingi, Nuray Bayar Muluk

3. The Principles of GCP
Cemal Cingi, Nuray Bayar Muluk

4. The Drug Development Process and Evolution of Regulations
Cemal Cingi, Nuray Bayar Muluk

5. Planning Clinical Research
Cemal Cingi, Nuray Bayar Muluk

6. Preparation of Ethics Committee (IRB) Proposal
Cemal Cingi, Nuray Bayar Muluk

7. Preparation of Informed Consent
Cemal Cingi, Nuray Bayar Muluk

8. Preparation of Findings Tables
Cemal Cingi, Nuray Bayar Muluk

9. Setting the Ideal Statistical Methods
Cemal Cingi, Nuray Bayar Muluk

10. The Duties of a Clinical Research Coordinator
Cemal Cingi, Nuray Bayar Muluk

11. The Duties of Clinical Researchers
Cemal Cingi, Nuray Bayar Muluk

12. The Phases of Clinical Studies
Cemal Cingi, Nuray Bayar Muluk

13. Safety in Clinical Trials
Cemal Cingi, Nuray Bayar Muluk

14. Setting the Size
Cemal Cingi, Nuray Bayar Muluk

15. Setting the Ideal Method
Cemal Cingi, Nuray Bayar Muluk

16. Ethics of Clinical Research
Cemal Cingi, Nuray Bayar Muluk

17. Recruitment and Enrolment
Cemal Cingi, Nuray Bayar Muluk

18. Why We Need Clinical Consent and Other Documentation
Cemal Cingi, Nuray Bayar Muluk

19. Monitoring the Trial
Cemal Cingi, Nuray Bayar Muluk

20. Inspection
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21. Ethics: Institutional Review Board/Independent Ethics Committee (IRB/IEC)
Cemal Cingi, Nuray Bayar Muluk

22. Responsibilities of the Investigator
Cemal Cingi, Nuray Bayar Muluk

23. Responsibilities of the Sponsor
Cemal Cingi, Nuray Bayar Muluk

24. Clinical Trial Protocols
Cemal Cingi, Nuray Bayar Muluk

Nyckelord: Medicine & Public Health, Drug Safety and Pharmacovigilance, Statistics for Life Sciences, Medicine, Health Sciences, General Surgery, Medical Education