Curriculum
The Clinical Research program at Iihmr University Jaipur is structured over eight semesters, combining core courses, departmental electives, science electives, and laboratory sessions to provide a comprehensive educational experience. The curriculum emphasizes both theoretical knowledge and practical application, preparing students for successful careers in clinical research across diverse domains.
Course Structure Overview
| Semester | Course Code | Course Title | Credits (L-T-P-C) | Prerequisites |
|---|---|---|---|---|
| 1 | CR-101 | Introduction to Clinical Research | 3-0-0-3 | - |
| 1 | CR-102 | Basic Biology for Clinical Research | 3-0-0-3 | - |
| 1 | CR-103 | Chemistry for Medical Sciences | 3-0-0-3 | - |
| 1 | CR-104 | Introduction to Statistics and Biostatistics | 3-0-0-3 | - |
| 1 | CR-105 | Human Anatomy & Physiology | 3-0-0-3 | - |
| 1 | CR-106 | Pharmacology Basics | 3-0-0-3 | - |
| 1 | CR-107 | Research Methodology | 2-0-0-2 | - |
| 2 | CR-201 | Clinical Trial Design | 3-0-0-3 | CR-101 |
| 2 | CR-202 | Epidemiology and Public Health | 3-0-0-3 | CR-104 |
| 2 | CR-203 | Toxicology Fundamentals | 3-0-0-3 | CR-103 |
| 2 | CR-204 | Regulatory Affairs in Healthcare | 3-0-0-3 | CR-101 |
| 2 | CR-205 | Pharmacokinetics & Pharmacodynamics | 3-0-0-3 | CR-106 |
| 2 | CR-206 | Good Clinical Practice (GCP) | 2-0-0-2 | CR-101 |
| 3 | CR-301 | Advanced Drug Development | 3-0-0-3 | CR-205 |
| 3 | CR-302 | Biostatistics for Clinical Trials | 3-0-0-3 | CR-104 |
| 3 | CR-303 | Clinical Ethics and Governance | 3-0-0-3 | CR-204 |
| 3 | CR-304 | Pharmacovigilance | 3-0-0-3 | CR-205 |
| 3 | CR-305 | Data Management in Clinical Research | 3-0-0-3 | CR-104 |
| 3 | CR-306 | Introduction to Bioinformatics | 2-0-0-2 | CR-102 |
| 4 | CR-401 | Special Topics in Oncology Research | 3-0-0-3 | CR-301 |
| 4 | CR-402 | Immunology and Autoimmune Disorders | 3-0-0-3 | CR-205 |
| 4 | CR-403 | Cardiovascular Clinical Research | 3-0-0-3 | CR-301 |
| 4 | CR-404 | Neuroscience in Clinical Trials | 3-0-0-3 | CR-205 |
| 4 | CR-405 | Global Health Research | 3-0-0-3 | CR-202 |
| 4 | CR-406 | Project Management in Clinical Research | 2-0-0-2 | CR-201 |
| 5 | CR-501 | Clinical Data Analytics | 3-0-0-3 | CR-302 |
| 5 | CR-502 | Machine Learning in Healthcare | 3-0-0-3 | CR-302 |
| 5 | CR-503 | Biomarker Discovery | 3-0-0-3 | CR-301 |
| 5 | CR-504 | Regulatory Submission Writing | 3-0-0-3 | CR-204 |
| 5 | CR-505 | Translational Medicine | 3-0-0-3 | CR-301 |
| 5 | CR-506 | Drug Safety & Risk Management | 2-0-0-2 | CR-304 |
| 6 | CR-601 | Capstone Project - Clinical Research | 6-0-0-6 | All previous courses |
| 6 | CR-602 | Advanced Clinical Trial Design | 3-0-0-3 | CR-201 |
| 6 | CR-603 | Clinical Research Ethics | 2-0-0-2 | CR-303 |
| 6 | CR-604 | Pharmaceutical Industry Insights | 2-0-0-2 | - |
| 7 | CR-701 | Internship in Clinical Research | 6-0-0-6 | All previous courses |
| 8 | CR-801 | Advanced Capstone Project | 6-0-0-6 | All previous courses |
Detailed Course Descriptions
The following are detailed descriptions of several advanced departmental elective courses offered in the Clinical Research program:
- Clinical Data Analytics: This course explores methods for analyzing large datasets generated during clinical trials. Students learn about data cleaning, visualization, statistical modeling, and predictive analytics using tools like R, Python, and SAS. The course emphasizes practical applications in healthcare decision-making and regulatory submissions.
- Machine Learning in Healthcare: Focused on applying machine learning algorithms to healthcare applications such as early diagnosis of diseases, drug discovery, and personalized treatment plans. Students gain hands-on experience with datasets from real clinical studies and learn how to interpret results for clinical decision support systems.
- Biomarker Discovery: Students investigate how biomarkers are identified, validated, and used in clinical settings for diagnosing conditions or monitoring therapeutic responses. The course covers molecular techniques, validation strategies, and regulatory considerations for biomarker use in diagnostics and therapeutics.
- Regulatory Submission Writing: This course teaches students how to prepare regulatory documents required for drug approval, including INDs, NDAs, and BLAs, adhering to guidelines from FDA, EMA, and other agencies. It includes writing practice sessions, peer review exercises, and mock submissions to simulate real-world scenarios.
- Translational Medicine: Examines the process of translating basic research findings into clinical applications, focusing on challenges in moving discoveries from bench to bedside. The course explores translational pathways, regulatory frameworks, and collaborative models between academia and industry.
- Drug Safety & Risk Management: Covers risk assessment strategies, adverse event reporting systems, and post-market surveillance methods for ensuring patient safety. Students learn how to develop risk management plans, conduct safety signal detection, and communicate risks effectively to stakeholders.
- Global Health Research: Addresses public health issues at global scales, including infectious disease outbreaks, health policy analysis, and international collaboration in research. The course includes case studies from WHO reports, fieldwork opportunities, and exposure to global health initiatives.
- Neuroscience in Clinical Trials: Focuses on neurological disorders and their treatment through clinical research, covering topics like neuroimaging, cognitive testing, and neuropharmacology. Students learn how to design trials for neurodegenerative diseases, psychiatric conditions, and neurological complications.
- Immunology and Autoimmune Disorders: Explores immune system function and dysfunction, particularly autoimmune diseases, with emphasis on clinical trial design and treatment strategies. The course includes exposure to current research trends in immunotherapy and personalized medicine approaches.
- Advanced Clinical Trial Design: Builds upon foundational knowledge to cover complex trial designs such as adaptive trials, basket trials, and umbrella trials, emphasizing flexibility and efficiency in research protocols. Students learn how to design efficient trials that can adapt based on interim analyses and evolving scientific understanding.
The department's philosophy on project-based learning is rooted in the belief that practical experience enhances theoretical understanding. Throughout the program, students engage in mini-projects during the first four semesters, which serve as stepping stones toward larger capstone initiatives. These projects are typically aligned with current research trends or industry needs and allow students to develop critical thinking, problem-solving, and teamwork skills.
Mini-projects begin with a structured proposal phase, where students identify relevant topics, review literature, and formulate hypotheses. Faculty mentors guide students through data collection, analysis, and interpretation phases. Evaluation criteria include clarity of presentation, methodology soundness, depth of insight, and potential impact on clinical practice or policy.
The final-year capstone project is a comprehensive endeavor that requires students to design and execute an independent research study under close supervision from faculty advisors. Projects often involve collaboration with external partners such as pharmaceutical companies, hospitals, or government agencies. The goal is to produce original contributions to the field of clinical research, which may include peer-reviewed publications, conference presentations, or patent applications.