Comprehensive Course Structure
| Semester | Course Code | Course Title | Credit Structure (L-T-P-C) | Prerequisites |
|---|---|---|---|---|
| 1 | CR101 | Introduction to Clinical Research | 3-0-0-3 | None |
| 1 | CR102 | Biological Sciences | 3-0-0-3 | None |
| 1 | CR103 | Chemistry for Clinical Research | 3-0-0-3 | None |
| 1 | CR104 | Statistics for Clinical Research | 3-0-0-3 | None |
| 1 | CR105 | Introduction to Pharmacology | 3-0-0-3 | None |
| 2 | CR201 | Clinical Trial Design | 3-0-0-3 | CR101 |
| 2 | CR202 | Epidemiology | 3-0-0-3 | CR104 |
| 2 | CR203 | Toxicology | 3-0-0-3 | CR102 |
| 2 | CR204 | Human Subjects Research Ethics | 3-0-0-3 | CR101 |
| 2 | CR205 | Pharmacokinetics | 3-0-0-3 | CR103 |
| 3 | CR301 | Biostatistics | 3-0-0-3 | CR202 |
| 3 | CR302 | Regulatory Affairs | 3-0-0-3 | CR204 |
| 3 | CR303 | Clinical Data Management | 3-0-0-3 | CR201 |
| 3 | CR304 | Good Clinical Practice | 3-0-0-3 | CR204 |
| 3 | CR305 | Drug Development Process | 3-0-0-3 | CR205 |
| 4 | CR401 | Translational Research | 3-0-0-3 | CR305 |
| 4 | CR402 | Personalized Medicine | 3-0-0-3 | CR301 |
| 4 | CR403 | Pharmacovigilance | 3-0-0-3 | CR302 |
| 4 | CR404 | Clinical Trial Management | 3-0-0-3 | CR303 |
| 4 | CR405 | Global Health Research | 3-0-0-3 | CR202 |
| 5 | CR501 | Advanced Clinical Trial Design | 3-0-0-3 | CR401 |
| 5 | CR502 | Clinical Research Project | 3-0-0-3 | CR404 |
| 5 | CR503 | Health Informatics | 3-0-0-3 | CR301 |
| 5 | CR504 | Research Ethics and Compliance | 3-0-0-3 | CR402 |
| 5 | CR505 | Drug Safety and Risk Management | 3-0-0-3 | CR303 |
| 6 | CR601 | Capstone Project | 3-0-0-3 | CR502 |
| 6 | CR602 | Internship | 3-0-0-3 | CR502 |
| 6 | CR603 | Advanced Data Analysis | 3-0-0-3 | CR503 |
| 6 | CR604 | Clinical Research in Practice | 3-0-0-3 | CR504 |
| 6 | CR605 | Research Proposal Writing | 3-0-0-3 | CR501 |
| 7 | CR701 | Advanced Topics in Clinical Research | 3-0-0-3 | CR601 |
| 7 | CR702 | Global Regulatory Framework | 3-0-0-3 | CR604 |
| 7 | CR703 | Clinical Research Leadership | 3-0-0-3 | CR601 |
| 7 | CR704 | Research Publication and Presentation | 3-0-0-3 | CR605 |
| 7 | CR705 | Industry Collaboration Projects | 3-0-0-3 | CR701 |
| 8 | CR801 | Final Year Thesis | 3-0-0-3 | CR701 |
| 8 | CR802 | Professional Development | 3-0-0-3 | CR704 |
| 8 | CR803 | Capstone Research | 3-0-0-3 | CR801 |
| 8 | CR804 | Research Ethics and Compliance | 3-0-0-3 | CR801 |
| 8 | CR805 | Industry Engagement | 3-0-0-3 | CR703 |
Advanced Departmental Elective Courses
Advanced departmental elective courses in Clinical Research are designed to provide students with specialized knowledge and practical skills in specific areas of the field. These courses are offered in the latter part of the program, allowing students to focus on their areas of interest and prepare for advanced research or industry roles.
One such course is 'Advanced Clinical Trial Design', which delves into the complexities of designing clinical trials for specific therapeutic areas. Students learn about adaptive trial designs, biomarker-driven trials, and the integration of real-world evidence in trial protocols. This course is led by Dr. Ramesh Kumar, who brings his extensive experience in global clinical trial design to the classroom.
'Biostatistics and Data Science in Clinical Research' is another advanced elective that focuses on the application of statistical methods and machine learning in clinical research. This course is taught by Dr. Anjali Mehta, who has published extensively on the use of big data in healthcare. Students gain hands-on experience with advanced statistical software and learn to apply predictive modeling techniques to clinical datasets.
'Regulatory Affairs and Compliance' provides students with a deep understanding of the regulatory landscape governing clinical research. This course covers the regulatory processes in major markets, including the FDA, EMA, and other global regulatory bodies. Dr. Nisha Gupta, a leading expert in clinical ethics and regulatory affairs, leads this course.
'Translational Research and Personalized Medicine' explores the integration of basic research findings into clinical applications. Students learn about genomics, proteomics, and personalized treatment strategies. This course is led by Dr. Deepak Singh, who has pioneered several translational research initiatives.
'Clinical Data Management and Quality Assurance' focuses on the management and quality control of clinical data. Students learn about data collection, validation, and management systems. This course is taught by Dr. Priya Sharma, who has extensive experience in clinical data management.
'Pharmacovigilance and Drug Safety' covers the monitoring and evaluation of adverse effects of drugs. Students learn about signal detection, risk management, and safety reporting. This course is led by Dr. Suresh Patel, who has worked extensively in drug safety and pharmacovigilance.
'Clinical Trial Management and Operations' provides students with practical skills in managing clinical trials. This course covers trial initiation, monitoring, and close-out processes. Dr. Arjun Patel, who has led numerous clinical trials, teaches this course.
'Global Health Research and Policy' explores the intersection of global health issues and clinical research. Students learn about health policy, global health disparities, and research ethics in international settings. This course is led by Dr. Nisha Gupta.
'Health Informatics and Digital Health' introduces students to the role of digital technologies in clinical research. Students learn about electronic health records, mobile health applications, and data analytics in healthcare. This course is taught by Dr. Priya Sharma.
'Clinical Research Ethics and Human Subjects Protection' delves into the ethical considerations in clinical research. Students learn about informed consent, ethical review processes, and the protection of vulnerable populations. This course is led by Dr. Nisha Gupta.
'Drug Development and Regulatory Strategy' focuses on the strategic aspects of drug development. Students learn about market analysis, regulatory strategy, and the commercialization of new drugs. This course is taught by Dr. Ramesh Kumar.
'Clinical Research Project Management' provides students with skills in managing research projects from conception to completion. This course covers project planning, risk management, and resource allocation. Dr. Arjun Patel leads this course.
'Clinical Research in Rare Diseases' focuses on the challenges and opportunities in researching rare diseases. Students learn about orphan drug development, patient registries, and the regulatory environment for rare disease treatments. This course is led by Dr. Suresh Patel.
'Infectious Disease Research and Clinical Trials' explores the design and execution of clinical trials for infectious diseases. Students learn about vaccine development, antimicrobial resistance, and global health threats. This course is taught by Dr. Deepak Singh.
'Clinical Research in Mental Health' addresses the unique challenges in conducting clinical research in mental health. Students learn about psychiatric drug development, clinical trial design, and ethical considerations. This course is led by Dr. Priya Sharma.
'Clinical Research in Cardiovascular Disease' focuses on cardiovascular disease research and clinical trial design. Students learn about heart disease risk factors, drug development, and clinical trial outcomes. This course is taught by Dr. Ramesh Kumar.
Project-Based Learning Philosophy
The department's philosophy on project-based learning is rooted in the belief that real-world experience is essential for developing competent and confident clinical researchers. Students engage in both mini-projects and a final-year thesis, which are designed to provide hands-on experience and foster critical thinking skills.
The mini-projects, undertaken in the third and fourth years, allow students to apply theoretical knowledge to practical scenarios. These projects are typically collaborative, involving students working in teams to address real challenges in clinical research. The projects are guided by faculty members who provide mentorship and support throughout the process.
The final-year thesis is a comprehensive research project that requires students to conduct independent research under the supervision of a faculty mentor. The thesis is a significant component of the program, as it allows students to demonstrate their mastery of clinical research principles and their ability to contribute to the field through original research.
Students select their projects and faculty mentors based on their interests and career goals. The department provides a list of potential research topics and faculty mentors, and students are encouraged to discuss their preferences with faculty members. The selection process ensures that students are matched with projects that align with their interests and career aspirations.