16. SAFETY MONITORING IN CLINICAL TRIALS
Safety monitoring is one of the most essential components of any clinical trial. Its purpose is to ensure that participants are protected from unnecessary risks and that emerging safety information…
15. DATA MANAGEMENT AND ITS COMPONENTS
Clinical Data Management (CDM) is a critical process in every clinical trial. It ensures that the data collected during the study is accurate, complete, secure, and reliable enough for statistical…
14. INFORMED CONSENT PROCESS
The Informed Consent Process is one of the most important ethical requirements in clinical research. It ensures that individuals voluntarily participate in a trial with full understanding of the study’s…
13. DESIGNING OF CLINICAL STUDY DOCUMENTS (Protocol, CRF, ICF)
Clinical study documents form the backbone of every clinical trial. They provide structure, ensure compliance with Good Clinical Practice (GCP), and protect participant rights while maintaining data integrity. Among all…
12. ABBREVIATED NEW DRUG APPLICATION
The Abbreviated New Drug Application (ANDA) is the official approval pathway for generic drugs in the United States. Introduced under the Hatch–Waxman Act of 1984, ANDA allows pharmaceutical companies to…
11. ROLE AND RESPONSIBILITIES OF CLINICAL TRIAL PERSONNEL AS PER ICH GCP
The conduct of a clinical trial requires the coordinated effort of multiple trained professionals. The International Council for Harmonisation – Good Clinical Practice (ICH GCP) guidelines outline clear responsibilities for…
10. OVERVIEW OF REGULATORY ENVIRONMENT IN USA, EUROPE AND INDIA
The global pharmaceutical industry relies heavily on strong regulatory systems to ensure that drugs are safe, effective, and of high quality before reaching patients. Understanding the regulatory environment in the…