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
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3. The Principles of GCP
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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
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8. Preparation of Findings Tables
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9. Setting the Ideal Statistical Methods
Cemal Cingi, Nuray Bayar Muluk

10. The Duties of a Clinical Research Coordinator
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11. The Duties of Clinical Researchers
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12. The Phases of Clinical Studies
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13. Safety in Clinical Trials
Cemal Cingi, Nuray Bayar Muluk

14. Setting the Size
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15. Setting the Ideal Method
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16. Ethics of Clinical Research
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17. Recruitment and Enrolment
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18. Why We Need Clinical Consent and Other Documentation
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19. Monitoring the Trial
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20. Inspection
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21. Ethics: Institutional Review Board/Independent Ethics Committee (IRB/IEC)
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22. Responsibilities of the Investigator
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23. Responsibilities of the Sponsor
Cemal Cingi, Nuray Bayar Muluk

24. Clinical Trial Protocols
Cemal Cingi, Nuray Bayar Muluk

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