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Table of Contents *
Evolution of the Homo Sapiens and his Mutant, the Clinical Investigatoriens
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Clinical Research: Dotted, Spotted, Colored and Flavored
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The Protocol: ?Thou Shalt Pay Thy Obedience?
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The Case Report Form (CRF): Hardcore Proof of Your Work
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Obtaining Informed Consent: Essentially a Ritual or an Essential Ritual
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That Magical Phrase: GCPs (Good Clinical Practices)
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Use of Surrogate Markers in Clinical Research: Haste that does not Waste
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Facts and Figures: Fodder for the Statistician
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Parametric and Nonparametric Tests
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Be Wholesome and Avoid Criticism Later
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Interpreting Statistical Jargon: Clarifying Obscurity
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Data (Handling): Not Fragile and Breakable but Handle with Care
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Portfolio and Project Management: Intellectual Property: Types, Rights and Caveats
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Ethics of Clinical Research: Think Just and Act Just
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Conflicts of Interest: Transparency may Invoke
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Evidence-Based Medicine (EBM): Need of the Day
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Scientific misconduct: Plain carelessness or....?
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Appendix I. Table of Contents of a Protocol
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Appendix II. Random Number Table
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Appendix III. Sample Case Record Form (CRF) for a Small, Nonfounded, Investigator Initiated Diabetes Study *
Appendix IV. Informed Consent Document Template
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Appendix V. Nomogram for Sample Size Calculation
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Appendix VI. The Declaration of Helsinki
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Appendix VII. The Nuremberg Code (1947)
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Appendix VIII. Standard Operating Procedures of Ethics Committee
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Appendix IX. The QUOROM Statement
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Index