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B-SC-CLINICAL-RESEARCH in General at Sri Ramachandra Institute of Higher Education and Research
Chennai, Tamil Nadu
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About the Specialization
What is General at Sri Ramachandra Institute of Higher Education and Research Chennai?
This B.Sc. Clinical Research program at Sri Ramachandra Institute of Higher Education and Research focuses on equipping students with essential knowledge and practical skills for the dynamic field of clinical trials. It covers drug development, regulatory affairs, data management, and ethical considerations. India is a significant hub for clinical research, driven by its large patient pool and cost-effective research environment, making this program highly relevant for the burgeoning healthcare sector.
Who Should Apply?
This program is ideal for fresh graduates with a science background (Physics, Chemistry, Biology) who aspire to contribute to drug development and healthcare innovation. It also suits individuals seeking a robust foundation for further studies in clinical research or related life sciences. Aspiring clinical research coordinators, data managers, and regulatory associates will find this curriculum particularly beneficial, aligning with specific prerequisite science knowledge.
Why Choose This Course?
Graduates of this program can expect promising career paths as Clinical Research Coordinators, Data Managers, Regulatory Affairs Associates, Pharmacovigilance Associates, or Medical Writers in India. Entry-level salaries typically range from INR 2.5 Lakhs to 4.5 Lakhs per annum, with significant growth potential up to INR 8-12 Lakhs for experienced professionals in CROs, pharmaceutical companies, and hospitals. The curriculum prepares students for relevant professional certifications.
Student Success Practices
Foundation Stage
Build Strong Scientific Fundamentals- (Semester 1-2)
Focus intensely on foundational subjects like Anatomy, Physiology, Biochemistry, Pharmacology, Pathology, and Microbiology. Use textbooks, anatomical models, and lab sessions to grasp core concepts. Form study groups to discuss complex topics and clarify doubts, creating a robust base for specialized clinical research subjects.
Tools & Resources
Essential textbooks (e.g., Guyton & Hall for Physiology, Robbins for Pathology), Medical dictionaries, Lab manuals, Online anatomy/physiology atlases
Career Connection
A solid understanding of human biology and disease mechanisms is crucial for interpreting clinical trial data, understanding drug effects, and identifying adverse events in later stages. This knowledge is essential for roles in drug safety and clinical monitoring.
Develop Essential Data & Communication Skills- (Semester 1-2)
Pay close attention to Biostatistics and Computer Applications. Practice statistical analysis using software (e.g., Excel, introductory SPSS) and enhance proficiency in MS Office for professional documentation. Simultaneously, actively participate in English and Environmental Science & Ethics classes to refine communication and ethical reasoning.
Tools & Resources
SPSS/R tutorials, Online courses on Excel, Grammar handbooks, Public speaking clubs, Case studies on research ethics
Career Connection
Strong biostatistical understanding is vital for data analysis roles, while computer proficiency is a basic requirement across all clinical research functions. Excellent communication ensures effective interaction with sites, sponsors, and regulatory bodies.
Engage in Early Research Exposure- (Semester 1-2)
Beyond coursework, seek opportunities to attend seminars or workshops on research methodology or current healthcare trends, even if introductory. Read up on simple research articles or news about clinical trials in India. This proactive engagement will spark early interest and provide context for future studies.
Tools & Resources
University library resources, PubMed, Healthcare news portals (e.g., Express Pharma, BioSpectrum India), Departmental seminars
Career Connection
Early exposure helps students understand the practical relevance of their studies, informs their career choices, and develops a research-oriented mindset valued in the clinical research industry.
Intermediate Stage
Master Clinical Research Principles & Regulations- (Semester 3-5)
Dive deep into Introduction to Clinical Research, GCP, Clinical Trials Operations & Management, and Regulatory Affairs. Aim to understand the ''''why'''' behind each guideline and regulation. Engage in mock protocol development and ethical committee reviews. Consider pursuing an online ICH-GCP certification.
Tools & Resources
ICH-GCP guidelines (official website), CDSCO guidelines, Industry webinars, Case studies of clinical trial failures/successes, NPTEL courses on clinical trials
Career Connection
A thorough grasp of GCP and regulatory frameworks is non-negotiable for any role in clinical research, from monitoring to regulatory submissions. Certifications enhance employability significantly.
Cultivate Practical Data & Documentation Expertise- (Semester 3-5)
Focus heavily on Clinical Data Management and Medical Writing subjects. Practice designing CRFs, entering data, resolving queries, and writing various medical documents like protocols and patient information sheets. Use real-world examples (anonymized) to apply concepts learned in class.
Tools & Resources
Mock CRFs, Industry templates for medical documents, Software like EDC systems (if available for demo), Scientific writing guides
Career Connection
Proficiency in data management and medical writing opens doors to specialized roles in CROs and pharmaceutical companies, which are constantly in demand for skilled professionals.
Network with Industry Professionals- (Semester 3-5)
Actively seek out opportunities to interact with professionals through guest lectures, industry events, or informational interviews. Utilize platforms like LinkedIn to connect with alumni and experts in clinical research. These interactions can provide valuable insights, mentorship, and potential internship leads.
Tools & Resources
LinkedIn, Professional associations (e.g., Indian Association for Clinical Research - IACR), Career fairs, University alumni network
Career Connection
Networking is crucial for understanding industry trends, discovering unadvertised opportunities, and building a professional circle that can support career growth and job search efforts.
Advanced Stage
Excel in Project Work and Internships- (Semester 6)
Treat the final semester Project Work / Internship as a critical bridge to the industry. Choose a project topic aligned with your career interests and apply all learned concepts. For internships, actively seek placements in reputable CROs, pharma companies, or hospitals to gain hands-on experience in real clinical trial settings.
Tools & Resources
University''''s placement cell, Industry contacts, Research databases, Mentorship from faculty and industry supervisors
Career Connection
A well-executed project demonstrates practical skills to potential employers. Internships often lead to pre-placement offers or provide invaluable experience that makes a candidate highly marketable.
Specialize and Prepare for Specific Roles- (Semester 6 onwards)
Based on your interests and strengths, choose the elective wisely (e.g., Medical Law & Bioethics, Advanced Epidemiology). Deepen your knowledge in your chosen area. Simultaneously, start preparing for interviews, refining your resume, and practicing mock interviews for specific roles like Clinical Research Coordinator, Data Analyst, or Pharmacovigilance Associate.
Tools & Resources
Career counseling services, Online interview preparation platforms, Job portals (Naukri, LinkedIn), Industry-specific job descriptions
Career Connection
Targeted preparation for specialized roles significantly increases the chances of securing a desirable position immediately after graduation in the competitive Indian job market.
Develop Professional & Leadership Qualities- (Semester 5-6)
Engage in activities that foster leadership, teamwork, and problem-solving skills, perhaps through student organizations or leading group projects. Cultivate a proactive attitude and strong work ethic. Understanding Quality Assurance & Audit and Hospital Management will also broaden your professional perspective.
Tools & Resources
Student clubs, Professional development workshops, Leadership books, Feedback from mentors
Career Connection
Beyond technical skills, employers value candidates with strong soft skills and leadership potential. These qualities are crucial for career progression into managerial and supervisory roles in clinical research.
Program Structure and Curriculum
Eligibility:
- Pass in 10+2 / HSC examination with Physics, Chemistry, Biology / Botany & Zoology and English. A minimum of 40% aggregate in Physics, Chemistry & Biology / Botany & Zoology. Minimum age 17 years by 31st December of the admission year.
Duration: 3 years (6 semesters)
Credits: 102 Credits
Assessment: Internal: 25%, External: 75%
Semester-wise Curriculum Table
Semester 1
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| CLR B 101 | Human Anatomy | Core Theory & Practical | 4 | General Anatomy and Terminology, Skeletal System (axial, appendicular), Muscular and Cardiovascular Systems, Nervous System (CNS, PNS, sensory organs), Digestive, Respiratory, Excretory Systems, Reproductive System and Embryology Basics |
| CLR B 102 | Human Physiology | Core Theory & Practical | 4 | General Physiology and Homeostasis, Blood and Body Fluids, Nerve and Muscle Physiology, Cardiovascular and Respiratory Physiology, Renal System and Fluid-Electrolyte Balance, Endocrine and Reproductive Physiology |
| CLR B 103 | Biochemistry | Core Theory & Practical | 4 | Biomolecules (Carbohydrates, Lipids, Proteins), Nucleic Acids and Bioenergetics, Enzymes and Metabolic Pathways, Digestion and Absorption of Nutrients, Vitamins, Minerals, and Nutrition, Organ Function Tests and Clinical Biochemistry |
| CLR B 104 | Environmental Science & Ethics | Core Theory | 2 | Environmental Studies Scope and Importance, Natural Resources and Ecosystems, Environmental Pollution and Management, Social Issues and the Environment, Human Rights and Professional Ethics, Ethical Principles in Healthcare and Research |
| CLR B 105 | English | Core Theory | 2 | Grammar and Usage for Effective Communication, Reading Comprehension and Critical Analysis, Writing Skills (Paragraph, Essay, Report), Verbal Communication and Presentation Skills, Basic Medical Terminology, Technical and Scientific Writing Principles |
Semester 2
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| CLR B 201 | Pharmacology I | Core Theory & Practical | 4 | General Pharmacology (Pharmacokinetics, Pharmacodynamics), Drugs Affecting Autonomic Nervous System, Cardiovascular Drugs (Anti-hypertensives, Anti-arrhythmics), Drugs Acting on Kidney and Blood, Drugs for Gastrointestinal Disorders, Introduction to Drug Development Process |
| CLR B 202 | Pathology | Core Theory & Practical | 4 | General Pathology (Cell Injury, Inflammation, Repair), Immunopathology and Hypersensitivity, Neoplasia (Benign and Malignant Tumors), Disorders of Cardiovascular and Respiratory Systems, Disorders of Gastrointestinal and Genitourinary Systems, Infectious Diseases and Blood Disorders |
| CLR B 203 | Microbiology | Core Theory & Practical | 4 | General Microbiology (Sterilization, Culture Media), Bacteriology (Morphology, Pathogenesis, Antimicrobials), Virology (Replication, Viral Diseases), Mycology (Fungal Infections), Parasitology (Protozoa, Helminths), Immunology (Immunity, Vaccines, Hypersensitivity) |
| CLR B 204 | Biostatistics | Core Theory | 3 | Introduction to Biostatistics (Data Types, Variables), Measures of Central Tendency and Dispersion, Probability and Sampling Techniques, Hypothesis Testing (t-test, Chi-square test), Correlation and Regression Analysis, Introduction to Statistical Software (SPSS/R) |
| CLR B 205 | Computer Applications | Core Theory & Practical | 3 | Fundamentals of Computers (Hardware, Software, OS), MS Office Suite (Word, Excel, PowerPoint), Internet, Email and Online Communication, Data Management and Database Concepts, Computer Security and Ethics, Biomedical Applications of Computers |
Semester 3
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| CLR B 301 | Pharmacology II | Core Theory & Practical | 4 | Endocrine Pharmacology (Hormones, Antidiabetics), Chemotherapy (Antibiotics, Antivirals, Antifungals), Anticancer Drugs and Immunomodulators, Drugs Acting on Central Nervous System (CNS), Drugs for Respiratory Disorders, Autacoids and NSAIDs |
| CLR B 302 | Research Methodology | Core Theory | 3 | Introduction to Research and Research Ethics, Types of Research and Research Design, Sampling Methods and Sample Size Calculation, Data Collection Tools and Techniques, Data Analysis and Interpretation, Research Report Writing and Presentation |
| CLR B 303 | Introduction to Clinical Research | Core Theory & Practical | 4 | Fundamentals of Clinical Research and its History, Phases of Clinical Trials (Pre-clinical to Phase IV), Types of Clinical Studies and Designs, Roles and Responsibilities in Clinical Research, Ethical Considerations in Clinical Research, Overview of Regulatory Framework (ICH-GCP) |
| CLR B 304 | Clinical Biochemistry & Nutrition | Core Theory | 3 | Introduction to Clinical Biochemistry, Diagnostic Tests for Organ Functions, Electrolyte and Acid-Base Balance, Hormonal Assays and Tumor Markers, Principles of Nutrition (Macro/Micronutrients), Nutritional Assessment and Diet Planning |
| CLR B 305 | Medical Sociology & Psychology | Core Theory | 2 | Introduction to Sociology of Health, Social Determinants of Health and Disease, Healthcare Delivery Systems in India, Introduction to Psychology and Behavior, Health Psychology and Stress Management, Communication Skills in Healthcare Settings |
Semester 4
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| CLR B 401 | Clinical Trials Operations & Management I | Core Theory & Practical | 4 | Clinical Trial Protocol Development, Investigator''''s Brochure and Informed Consent Process, Site Selection, Initiation, and Management, Clinical Trial Monitoring (On-site, Remote), Essential Clinical Trial Documentation (TMF, ISF), Quality Management in Clinical Trials |
| CLR B 402 | Good Clinical Practice (GCP) | Core Theory | 3 | History and Principles of ICH-GCP, Responsibilities of Investigator and Sponsor, Institutional Review Board (IRB)/Ethics Committee, Informed Consent Process in Detail, Confidentiality and Data Protection, Audit and Regulatory Inspections |
| CLR B 403 | Clinical Data Management | Core Theory & Practical | 4 | Introduction to Clinical Data Management (CDM), Role of Data Manager and CDM Process, Case Report Form (CRF) Design and Development, Database Setup and Validation, Data Entry, Cleaning, and Query Resolution, Data Lock, Archival, and Quality Control |
| CLR B 404 | Pharmacoepidemiology & Pharmacovigilance | Core Theory | 3 | Introduction to Pharmacoepidemiology, Study Designs in Pharmacoepidemiology, Introduction to Pharmacovigilance (PV), Adverse Drug Reaction (ADR) Reporting, Signal Detection and Risk Management, PV Regulations and Guidelines (CIOMS, India PV) |
| CLR B 405 | Communication & Soft Skills | Core Theory | 2 | Verbal and Non-Verbal Communication, Presentation Skills and Public Speaking, Interpersonal Skills and Teamwork, Time Management and Stress Management, Professional Ethics and Etiquette, Interview Skills and Resume Building |
Semester 5
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| CLR B 501 | Clinical Trials Operations & Management II | Core Theory & Practical | 4 | Vendor Management in Clinical Trials, Budgeting and Contracts Management, Investigational Product (IP) Accountability, Close-out Procedures and Archival, Safety Reporting and SAE Management, Clinical Trial Project Management |
| CLR B 502 | Regulatory Affairs in Clinical Research | Core Theory & Practical | 4 | Introduction to Regulatory Affairs and its Scope, Drug Discovery and Development Process, Key Regulatory Agencies (CDSCO, FDA, EMA), New Drug Application (NDA) and Investigational New Drug (IND), Post-Marketing Surveillance and Lifecycle Management, Indian Regulations (Drugs and Cosmetics Act, Rules) |
| CLR B 503 | Medical Writing | Core Theory & Practical | 3 | Principles of Effective Medical and Scientific Writing, Types of Medical Documents (Protocols, ICF, CSR), Scientific Publications (Research Papers, Review Articles), Regulatory Documents (IND/NDA Sections), Pharmacovigilance Documents (PSURs, DSURs), Ethical Considerations and Plagiarism in Writing |
| CLR B 504 | Advanced Biostatistics & Data Analysis | Core Theory & Practical | 4 | Review of Basic Statistical Concepts, Survival Analysis and Kaplan-Meier Curves, Non-Parametric Tests and Multivariate Analysis, Meta-Analysis and Systematic Reviews, Advanced Sample Size Calculation, Introduction to SAS/R for Clinical Data Analysis |
| CLR B 505 | Basics of Diagnostics & Medical Devices | Core Theory | 2 | Introduction to Medical Devices (Classification, Regulation), In-Vitro Diagnostics (IVDs) and their Development, Clinical Trials for Medical Devices, Quality Systems for Medical Devices, Biomarkers and Personalized Medicine, Regulatory Pathways for Diagnostics |
Semester 6
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| CLR B 601 | Quality Assurance & Audit in Clinical Research | Core Theory & Practical | 4 | Quality Management Systems (QMS) in Clinical Research, Quality Assurance (QA) vs. Quality Control (QC), Clinical Trial Audits (Internal, External), Regulatory Inspections and CAPA Management, Standard Operating Procedures (SOPs) Development, Risk-Based Quality Management |
| CLR B 602 | Health Economics & Outcomes Research | Core Theory | 3 | Introduction to Health Economics, Economic Evaluation Methods (CBA, CEA, CUA), Quality of Life (QoL) Measures, Outcomes Research Designs and Methodology, Real-World Evidence (RWE) in Healthcare, Health Technology Assessment (HTA) |
| CLR B 603 | Hospital Management & Healthcare Administration | Core Theory | 3 | Principles of Hospital Administration, Healthcare Delivery Models and Systems, Hospital Services and Operations Management, Financial Management in Healthcare, Human Resource Management in Hospitals, Healthcare Laws, Policies, and Ethics |
| CLR B 604 | Medical Law & Bioethics | Elective Theory | 3 | Legal System in India and Healthcare Law, Patient Rights and Responsibilities, Medical Negligence and Malpractice, Bioethics Principles (Autonomy, Beneficence, Justice), Ethical Issues in Clinical Research, Organ Donation, Transplantation, and Surrogacy Laws |
| CLR B 605 | Project Work / Internship | Project/Internship | 6 | Project Proposal Development and Literature Review, Research Design and Methodology Implementation, Data Collection, Analysis, and Interpretation, Report Writing and Scientific Presentation, Practical Application of Clinical Research Skills, Industry Exposure and Professional Networking |
