Course Structure Overview
The Clinical Research program at Indian Institute Of Public Health Gandhinagar is structured over 8 semesters, with a balanced mix of core courses, departmental electives, science electives, and laboratory training. The curriculum ensures that students develop both foundational knowledge and specialized skills required for a successful career in clinical research.
| Semester | Course Code | Course Title | Credits (L-T-P-C) | Prerequisites |
|---|---|---|---|---|
| 1 | CRS101 | Introduction to Clinical Research | 3-0-0-3 | None |
| 1 | CRS102 | Biology for Clinical Research | 4-0-0-4 | None |
| 1 | CRS103 | Chemistry and Biochemistry | 3-0-0-3 | None |
| 1 | CRS104 | Public Health Principles | 3-0-0-3 | None |
| 1 | CRS105 | Research Methodology | 2-0-0-2 | None |
| 1 | CRS106 | Statistics for Clinical Research | 3-0-0-3 | Mathematics |
| 2 | CRS201 | Epidemiology | 4-0-0-4 | Biology, Statistics |
| 2 | CRS202 | Pharmacology | 3-0-0-3 | Biology |
| 2 | CRS203 | Clinical Pharmacokinetics | 3-0-0-3 | Pharmacology |
| 2 | CRS204 | Biostatistics | 3-0-0-3 | Statistics |
| 2 | CRS205 | Research Ethics | 2-0-0-2 | None |
| 2 | CRS206 | Introduction to Health Informatics | 3-0-0-3 | None |
| 3 | CRS301 | Clinical Trial Design | 4-0-0-4 | Epidemiology, Biostatistics |
| 3 | CRS302 | Drug Development Process | 3-0-0-3 | Pharmacology |
| 3 | CRS303 | Regulatory Affairs | 3-0-0-3 | Research Ethics |
| 3 | CRS304 | Clinical Data Management | 3-0-0-3 | Statistics, Health Informatics |
| 3 | CRS305 | Health Economics | 3-0-0-3 | Epidemiology |
| 3 | CRS306 | Global Health Policy | 3-0-0-3 | Public Health Principles |
| 4 | CRS401 | Advanced Clinical Trials | 4-0-0-4 | Clinical Trial Design |
| 4 | CRS402 | Pharmacovigilance | 3-0-0-3 | Drug Development Process |
| 4 | CRS403 | Digital Health Technologies | 3-0-0-3 | Health Informatics |
| 4 | CRS404 | Clinical Research Capstone | 2-0-0-2 | All Core Courses |
| 4 | CRS405 | Global Health Surveillance | 3-0-0-3 | Epidemiology |
| 4 | CRS406 | Maternal and Child Health Research | 3-0-0-3 | Public Health Principles |
| 5 | CRS501 | Specialized Topics in Clinical Research | 3-0-0-3 | Clinical Trial Design |
| 5 | CRS502 | Pharmacokinetics and Pharmacodynamics | 4-0-0-4 | Pharmacology |
| 5 | CRS503 | Clinical Research Ethics and Compliance | 2-0-0-2 | Research Ethics |
| 5 | CRS504 | Health Data Analytics | 3-0-0-3 | Biostatistics |
| 5 | CRS505 | Public Health Research Methods | 3-0-0-3 | Epidemiology |
| 5 | CRS506 | AI in Clinical Research | 3-0-0-3 | Digital Health Technologies |
| 6 | CRS601 | Clinical Research Internship | 4-0-0-4 | Core Courses |
| 6 | CRS602 | Advanced Drug Safety | 3-0-0-3 | Pharmacovigilance |
| 6 | CRS603 | Global Health Research Project | 2-0-0-2 | Global Health Policy |
| 6 | CRS604 | Health Technology Assessment | 3-0-0-3 | Health Economics |
| 6 | CRS605 | Research Writing and Communication | 2-0-0-2 | None |
| 6 | CRS606 | Clinical Research Thesis | 4-0-0-4 | All Previous Courses |
| 7 | CRS701 | Advanced Clinical Trial Design | 3-0-0-3 | Clinical Trial Design |
| 7 | CRS702 | Health Economics Evaluation | 3-0-0-3 | Health Economics |
| 7 | CRS703 | Clinical Research Project Planning | 3-0-0-3 | Project Management |
| 7 | CRS704 | Digital Health Innovation | 3-0-0-3 | Digital Health Technologies |
| 7 | CRS705 | Clinical Research Leadership | 2-0-0-2 | Leadership Skills |
| 7 | CRS706 | Global Health Policy Review | 3-0-0-3 | Global Health Policy |
| 8 | CRS801 | Final Research Thesis | 6-0-0-6 | Thesis Proposal |
| 8 | CRS802 | Clinical Research Capstone Presentation | 2-0-0-2 | Final Thesis |
| 8 | CRS803 | Internship Report Writing | 2-0-0-2 | Internship |
| 8 | CRS804 | Clinical Research Portfolio Development | 2-0-0-2 | Capstone Project |
| 8 | CRS805 | Graduation Project | 4-0-0-4 | Final Thesis |
| 8 | CRS806 | Industry Collaboration Workshop | 2-0-0-2 | None |
Advanced Departmental Electives
Departmental electives are designed to deepen students' expertise in specific areas of clinical research:
Clinical Trial Design and Implementation
This course explores the principles of designing robust clinical trials, including randomization strategies, blinding techniques, sample size calculations, and endpoint selection. Students learn to evaluate trial protocols using international standards such as ICH-GCP guidelines.
Pharmacovigilance and Risk Management
This elective focuses on monitoring and managing drug safety risks throughout the lifecycle of a pharmaceutical product. Topics include signal detection, adverse event reporting systems, risk evaluation and mitigation strategies (REMS), and post-marketing surveillance activities.
Health Economics and Outcomes Research
Students study economic evaluations of health interventions using methods such as cost-effectiveness analysis, budget impact modeling, and quality-adjusted life years (QALYs). The course includes case studies from real-world healthcare settings.
Digital Health Technologies in Clinical Research
This course examines how digital technologies—such as mobile apps, wearables, telemedicine platforms, and AI algorithms—are transforming clinical research practices. Students gain hands-on experience with health data platforms and learn about regulatory considerations for digital therapeutics.
Global Health Policy and Regulatory Frameworks
The course introduces students to the complex landscape of global health governance, focusing on how policies shape healthcare delivery and research practices in low- and middle-income countries. It includes an overview of WHO regulations, national health systems, and ethical frameworks for international collaboration.
Clinical Data Management and Quality Assurance
This elective covers the principles of collecting, managing, and analyzing clinical data using industry-standard tools such as Oracle Clinical, Medidata Rave, and Veeva Vault. Students learn about data validation techniques, database design, and quality control measures.
Maternal and Child Health Research
This course focuses on the unique challenges facing maternal and child health in developing regions. Students study epidemiological trends, intervention strategies, and evaluation methods for programs aimed at reducing infant mortality, improving nutrition, and preventing infectious diseases.
Public Health Surveillance Systems
Students learn how to design and implement surveillance systems that track disease outbreaks, monitor health indicators, and generate actionable intelligence for policymakers. The course includes practical training in using real-time data platforms like PulsePoint and EpiInfo.
Clinical Research Ethics and Compliance
This course delves into ethical principles and regulatory requirements governing clinical research, including informed consent procedures, institutional review board (IRB) processes, and compliance with FDA and EMA guidelines. It emphasizes the importance of protecting vulnerable populations in research settings.
AI and Machine Learning for Clinical Research
This elective explores how artificial intelligence is revolutionizing clinical research through predictive modeling, natural language processing, and automated data analysis. Students work on projects using Python-based tools like scikit-learn and TensorFlow to solve real-world research problems.
Project-Based Learning Philosophy
The Clinical Research program at Indian Institute Of Public Health Gandhinagar is built on a strong foundation of project-based learning (PBL). This pedagogical approach emphasizes experiential education, where students engage in meaningful, real-world projects that bridge theory and practice.
Mini-projects are assigned in the second and third years, allowing students to apply fundamental concepts learned in lectures to practical scenarios. These projects typically involve designing a small-scale study, collecting data from a simulated or actual population, analyzing results using statistical software, and presenting findings to peers and faculty.
The final-year capstone project is a major undertaking that spans the entire semester. Students select a research topic of personal interest, develop a detailed proposal, secure a faculty mentor, and execute an independent study. The project culminates in a comprehensive thesis report and oral presentation before a panel of experts.
Project selection is guided by faculty mentors who help students align their interests with current trends in clinical research. Students are encouraged to choose projects that address pressing public health issues or contribute to ongoing research initiatives at the institute or partner organizations.
Evaluation criteria for all projects include research design quality, data integrity, analytical rigor, clarity of communication, and adherence to ethical standards. Peer reviews, mentor feedback, and final presentations play a crucial role in assessing student performance throughout their academic journey.