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Table of Contents

Chapter 1: Introduction
1.1 Background of the Study
1.2 Statement of the Problem
1.3 Objectives of the Study
1.4 Research Questions
1.5 Significance of the Study
1.6 Limitations of the Study
1.7 Scope of the Study

Chapter 2: Literature Review
2.1 Overview of Pharmacovigilance
2.2 Importance of Pharmacovigilance in Clinical Trials
2.3 Current Trends in Pharmacovigilance
2.4 Challenges in Pharmacovigilance in Clinical Trials
2.5 Regulatory Framework for Pharmacovigilance

Chapter 3: Research Methodology
3.1 Research Design
3.2 Data Collection Methods
3.3 Data Analysis Techniques
3.4 Sampling Techniques
3.5 Ethical Considerations

Chapter 4: Discussion of Findings
4.1 Overview of Study Findings
4.2 Comparison with Existing Literature
4.3 Implications of Findings
4.4 Recommendations for Future Research

Chapter 5: Conclusion and Summary
5.1 Summary of Findings
5.2 Conclusion
5.3 Recommendations for Practice
5.4 Limitations of the Study
5.5 Areas for Future Research

Brief Overview:

Pharmacovigilance in Clinical Trials is a critical aspect of drug development and patient safety. It involves the monitoring, detection, assessment, and prevention of adverse effects or any other drug-related problems associated with pharmaceutical products. This thesis aims to explore the current trends, challenges, and regulatory framework surrounding pharmacovigilance in clinical trials.

The study will address the importance of pharmacovigilance in ensuring the safety and efficacy of new drugs, as well as the significance of proper data collection and analysis techniques in monitoring adverse reactions. The research methodology will involve a comprehensive literature review and data analysis to provide insights into the current practices and challenges faced in pharmacovigilance in clinical trials.

Overall, this thesis will contribute to the existing body of knowledge in pharmacovigilance and provide recommendations for future research and practice in this field.

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