Table of Contents

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   Book Overview
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   Chapter 1 Clinical Trials: Historical Aspects and Importance and New Drug Developments
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   Chapter 2 The Definition of GCP
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   Chapter 3 The Principles of GCP
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   Chapter 4 The Drug Development Process and Evolution of Regulations
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   Chapter 5 Planning Clinical Research
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   Chapter 6 Preparation of Ethics Committee (IRB) Proposal
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   Chapter 7 Preparation of Informed Consent
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   Chapter 8 Preparation of Findings Tables
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    Chapter 9 Setting the Ideal Statistical Methods
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    Chapter 10 The Duties of a Clinical Research Coordinator
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    Chapter 11 The Duties of Clinical Researchers
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    Chapter 12 The Phases of Clinical Studies
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    Chapter 13 Safety in Clinical Trials
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    Chapter 14 Setting the Size
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    Chapter 15 Setting the Ideal Method
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    Chapter 16 Ethics of Clinical Research
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    Chapter 17 Recruitment and Enrolment
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    Chapter 18 Why We Need Clinical Consent and Other Documentation
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    Chapter 19 Monitoring the Trial
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    Chapter 20 Inspection
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    Chapter 21 Ethics: Institutional Review Board/Independent Ethics Committee (IRB/IEC)
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    Chapter 22 Responsibilities of the Investigator
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    Chapter 23 Responsibilities of the Sponsor
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    Chapter 24 Clinical Trial Protocols