Unit 1:
Introduction to Clinical Trials; Definition and objectives, Historical perspective; Ethical principles and guidelines, Requirement of preclinical validation.
Unit 2:
Phases of Clinical Trials; Phase I: First-in-Human Studies, Phase II: Proof-of-Concept Studies, Phase III: Efficacy and Safety Trials, Phase IV: Post-Marketing Surveillance.
Unit 3:
Clinical Trial Design; Randomization and blinding, Sample size determination, Endpoint selection and measurement.
Unit 4:
Participant Recruitment and Informed Consent, Strategies for participant recruitment, Informed consent process and documentation, Vulnerable populations and special considerations,
Unit 5:
Data Management and Quality Assurance, Electronic data capture systems, Data monitoring and auditing, Good Clinical Practice (GCP) guidelines.
Unit 6:
Regulatory Requirements and Submissions; FDA & CDSO regulations and guidance documents, Investigational New Drug (IND) application, Investigational Device Exemption (IDE) application.
Unit 7:
Ethics in Clinical Research; Institutional Review Board (IRB) review process, Protection of human subjects, Adverse event reporting and safety monitoring.
Unit 8:
Post-Market Surveillance and Compliance; Pharmacovigilance and adverse event reporting Risk management plans, Regulatory inspections and audits.

Preamble
Clinical Trials and Regulatory Affairs is a graduate-level course designed to provide students with a comprehensive understanding of the principles, methodologies, regulations, and ethical considerations involved in the conduct of clinical trials and the regulatory approval process for pharmaceuticals, biologics, and medical devices. The requirement of preclinical validation before clinical trial will be explained. The course will cover key topics such as trial design, participant recruitment, data management, regulatory submissions, and post-market surveillance.

Course outcome

CO1: To understand the purpose and significance of clinical trials in drug development and medical device evaluation.
CO2: To learn about different phases of clinical trials and their design considerations.
CO3: To acquire knowledge of regulatory requirements and guidelines governing clinical research and preclinical validation.
CO4: To develop skills in protocol development, study management, and data analysis.
CO5: To explore ethical considerations and patient safety in clinical trials.
CO6: To gain insights into post-market surveillance and regulatory compliance.

Program outcome (PO)

PO1: Utilize scientific principles and methodologies to design innovative solutions for data analysis, experimentation, and product development for challenges in translational research.
PO2: Recognize the importance of environmental sustainability in translational research and strive to minimize adverse environmental impacts.
PO3: Engage in ethical conduct, leadership, active listening, constructive feedback, and interpersonal communication to facilitate productive collaborations and knowledge exchange.
PO4: Acquire fundamental and advanced knowledge and skills in project management, financial planning, and entrepreneurship relevant to translational research ventures and initiatives.
3 = High Affinity, 2 = Medium Affinity, 1 = Low Affinity, – = No Affinity

Program Specific Outcome (PSO)

PSO1: Addresses the complexity of interdisciplinary sciences in biological and medical contexts.
PSO2: Deals with regulatory affairs in medicine, covering topics such as ethical considerations and regulatory frameworks.
PSO3: Covers compounds as drugs and their efficacy, involving pharmacology and drug development.
PSO4: Explores the intersection of bioinformatics and artificial intelligence in biology and medicine.
PSO5: Deals with technology in personalizing medicine, involving precision medicine approaches.
PSO6: Focuses on communicating and disseminating science and medicine to the public, involving science communication and public outreach efforts.

Machin, D., Day, S. and Green, S. eds., 2007. Textbook of clinical trials. John Wiley & Sons.