Curriculum Overview
The Clinical Research program at Aiph University Bhubaneswar is structured to provide a comprehensive and progressive academic journey that combines foundational knowledge with specialized expertise. The curriculum spans eight semesters, integrating core disciplines with practical applications through laboratory sessions, internships, and research projects.
| Semester | Course Code | Course Title | Credit (L-T-P-C) | Pre-requisites |
|---|---|---|---|---|
| 1 | CR101 | Introduction to Clinical Research | 3-0-0-3 | None |
| 1 | CR102 | Human Anatomy and Physiology | 4-0-0-4 | None |
| 1 | CR103 | Chemistry for Clinical Sciences | 3-0-0-3 | None |
| 1 | CR104 | Basic Statistics and Probability | 3-0-0-3 | None |
| 1 | CR105 | Introduction to Pharmacology | 3-0-0-3 | None |
| 1 | CR106 | Research Methodology and Ethics | 2-0-0-2 | None |
| 1 | CR107 | Laboratory Practical I | 0-0-3-1 | None |
| 2 | CR201 | Molecular Biology and Genetics | 4-0-0-4 | CR102, CR103 |
| 2 | CR202 | Epidemiology and Biostatistics | 3-0-0-3 | CR104 |
| 2 | CR203 | Pharmacokinetics and Pharmacodynamics | 3-0-0-3 | CR105 |
| 2 | CR204 | Drug Discovery and Development | 3-0-0-3 | CR103 |
| 2 | CR205 | Clinical Trial Design and Management | 3-0-0-3 | CR101, CR104 |
| 2 | CR206 | Laboratory Practical II | 0-0-3-1 | CR107 |
| 3 | CR301 | Regulatory Affairs in Clinical Research | 3-0-0-3 | CR205 |
| 3 | CR302 | Clinical Data Management Systems | 3-0-0-3 | CR205 |
| 3 | CR303 | Pharmacovigilance and Risk Management | 3-0-0-3 | CR203 |
| 3 | CR304 | Translational Medicine and Biomarkers | 3-0-0-3 | CR201 |
| 3 | CR305 | Global Health Policy and Ethics | 3-0-0-3 | CR106 |
| 3 | CR306 | Laboratory Practical III | 0-0-3-1 | CR206 |
| 4 | CR401 | Digital Health and AI in Clinical Research | 3-0-0-3 | CR205, CR302 |
| 4 | CR402 | Clinical Research Project I | 2-0-0-2 | CR306 |
| 4 | CR403 | Advanced Clinical Trial Design | 3-0-0-3 | CR205 |
| 4 | CR404 | Health Economics and Outcomes Research | 3-0-0-3 | CR202 |
| 4 | CR405 | Personalized Medicine and Genomics | 3-0-0-3 | CR201 |
| 4 | CR406 | Laboratory Practical IV | 0-0-3-1 | CR306 |
| 5 | CR501 | Clinical Research Project II | 2-0-0-2 | CR402 |
| 5 | CR502 | Regulatory Submissions and Documentation | 3-0-0-3 | CR301 |
| 5 | CR503 | Advanced Pharmacovigilance | 3-0-0-3 | CR303 |
| 5 | CR504 | Clinical Informatics and Data Analytics | 3-0-0-3 | CR202, CR302 |
| 5 | CR505 | Special Topics in Clinical Research | 3-0-0-3 | CR205 |
| 6 | CR601 | Clinical Research Project III | 2-0-0-2 | CR501 |
| 6 | CR602 | Industry Internship | 0-0-0-6 | CR402 |
| 7 | CR701 | Final Year Thesis/Capstone Project | 0-0-0-6 | CR601 |
| 7 | CR702 | Advanced Research Seminars | 2-0-0-2 | CR501 |
| 8 | CR801 | Capstone Project Defense | 0-0-0-3 | CR701 |
Detailed Course Descriptions
The Clinical Research program at Aiph University Bhubaneswar offers a rich array of advanced elective courses that delve deep into specialized areas of clinical research. These courses are designed to provide students with comprehensive knowledge and practical skills required in today's fast-evolving healthcare landscape.
Advanced Pharmacovigilance
This course provides an in-depth exploration of adverse event reporting, signal detection methods, risk management strategies, and post-market surveillance systems. Students learn how to monitor drug safety, analyze safety data, and implement corrective actions in response to safety concerns.
Clinical Informatics and Data Analytics
Students are introduced to the principles of clinical informatics, including electronic health records (EHRs), clinical decision support systems, and big data analytics. The course covers data mining techniques, machine learning applications, and the integration of technology in clinical research workflows.
Global Health Policy and Ethics
This course examines the intersection of health policy, ethics, and clinical research. It explores how policies shape research practices, regulatory frameworks across countries, and ethical considerations in conducting research with vulnerable populations.
Personalized Medicine and Genomics
The course focuses on how genetic variations influence treatment responses and develops strategies for individualized care based on molecular profiles. Students learn about genomic sequencing technologies, biomarker discovery, and the challenges of implementing personalized therapies in clinical settings.
Digital Health and AI in Clinical Research
This cutting-edge course explores how artificial intelligence, machine learning, and digital health innovations are transforming clinical research processes. Topics include wearable devices, remote monitoring systems, predictive analytics, and the use of AI in drug discovery and development.
Advanced Clinical Trial Design
This advanced course delves into complex trial designs such as adaptive trials, basket trials, and umbrella trials. Students learn how to design and analyze these sophisticated protocols while considering ethical implications and regulatory requirements.
Health Economics and Outcomes Research
The course introduces students to economic evaluation methods used in clinical research, including cost-effectiveness analysis, budget impact modeling, and health technology assessment. It emphasizes the role of evidence-based decision-making in healthcare resource allocation.
Translational Medicine and Biomarkers
This course bridges the gap between basic science discoveries and clinical applications. Students explore how biomarkers are identified, validated, and used in drug development processes, focusing on translational research methodologies and regulatory pathways.
Clinical Data Management Systems
Students gain hands-on experience with industry-standard data management systems and learn about data quality assurance, database design, validation procedures, and the role of clinical data managers in ensuring accurate and compliant data handling throughout trials.
Regulatory Submissions and Documentation
This course prepares students for the regulatory submission process by teaching them how to prepare and organize regulatory documents according to FDA, EMA, and other international guidelines. It covers aspects such as INDs, NDA submissions, and post-marketing reporting requirements.
Project-Based Learning Philosophy
The department's philosophy on project-based learning emphasizes experiential education where students apply theoretical knowledge to real-world clinical research challenges. This approach fosters critical thinking, problem-solving, and collaborative skills essential for success in the field.
Mini-projects are assigned during the first two years of study, allowing students to engage with practical scenarios such as designing a basic clinical trial protocol or analyzing health data sets. These projects are supervised by faculty members and often involve collaboration with industry partners or research institutions.
The final-year capstone project is a significant component of the program. Students select a topic aligned with their interests and work closely with a faculty mentor to conduct original research or develop an innovative solution to a clinical challenge. The project culminates in a comprehensive report and presentation before a panel of experts.
Students are encouraged to present their projects at national and international conferences, fostering networking opportunities and professional visibility. The selection process for projects involves discussions with faculty mentors and consideration of available resources, ensuring that students undertake meaningful and feasible research endeavors.