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Good Clinical Practice Guidelines

    Introduction

1. Definitions

2. Pre-requisites for the study

2.1.           Investigational Pharmaceutical Product

2.2.           Pre-Clinical supporting data

2.3.           Protocol

2.4.           Ethical & Safety Considerations

3. Responsibilities

3.1.           Sponsor

3.2.           The Monitor

3.3.           Investigator

4. Record Keeping and Data Handling

4.1.           Documentation

4.2.           Corrections

4.3.           Electronic Data Processing

4.4.           Validation of Electronic Data Processing Systems

4.5.           Language

4.6.           Responsibility of Investigator

4.7.           Responsibilities of Sponsor and Monitor

5. Quality Assurance

6. Statistics

6.1.           Role of Biostatistician

6.2.           Study design

6.3.           Statistical Analysis

7. Special Concerns

7.1.        Clinical Trials of Vaccines

7.2.        Clinical Trials of  contraceptives

7.3.        Clinical Trials with Surgical Procedures / Medical devices.

7.4.        Clinical Trials for Diagnostic agents – Use of radioactive materials and X-rays

7.5.        Clinical Trials of Herbal Remedies and Medicinal Plants

Appendices

Appendix I: Declaration of Helsinki

Appendix II: Schedule Y

Appendix III: Format for submission of Pre-clinical and clinical data for r-DNA based vaccines, diagnostics and other biologicals.

Appendix IV: Investigator’s Brochure

Appendix V: Essential Documents


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