JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objectives

This subject will provide a value addition and current requirement for the

students in clinical research and pharmacovigilance. It will teach the students on conceptualizing, designing, conducting, managing and reporting of clinical trials.This subject also focuses on global scenario of pharmacovigilance in different methods that can be used to generate safety data. It will teach the students in developing drug safety data in pre-clinical, clinical phases of drug development and post market surveillance.

Course Outcomes

Upon completion of the course, the student shall be able to;

• explain the regulatory requirements for conducting clinical trial
• Demonstrate the types of clinical trial designs
• Explain the responsibilities of key players involved in clinical trials
• Execute safety monitoring, reporting and close-out activities
• Explain the principles of Pharmacovigilance
• Detect new adverse drug reactions and their assessment
• Perform the adverse drug reaction reporting systems and communication in pharmacovigilance

UNIT - I

Regulatory Perspectives of Clinical Trials: Origin and Principles of International Conference on Harmonization - Good Clinical Practice (ICH- GCP) guidelines Ethical Committee: Institutional Review Board, Ethical Guidelines for Biomedical Research and Human Participant-Schedule Y, ICMR, Informed Consent Process: Structure and content of an Informed Consent Process Ethical principles governing informed consent process

UNIT - II

Clinical Trials: Types and Design: Experimental Study- RCT and Non RCT, Observation Study: Cohort, Case Control, Cross sectional Clinical Trial Study Team Roles and responsibilities of Clinical Trial Personnel: Investigator, Study Coordinator, Sponsor, Contract Research Organization and its management.

UNIT - III

Clinical Trial Documentation: Guidelines to the preparation of documents, Preparation of protocol, Investigator Brochure, Case Report Forms, Clinical Study Report Clinical Trial Monitoring-Safety Monitoring in CT Adverse Drug Reactions: Definition and types. Detection and reporting methods. Severity and seriousness assessment. predictability and preventability assessment. Management of adverse drug reactions; Terminologies of ADR.

UNIT - IV

Basic aspects, terminologies and establishment of pharmacovigilance: History and progress of pharmacovigilance, Significance of safety monitoring, Pharmacovigilance in India and international aspects, WHO international drug monitoring Program, WHO and Regulatory terminologies of ADR, evaluation of medication safety, establishing pharmacovigilance centres in Hospitals, Industry and National Programs related to pharmacovigilance. Roles and responsibilities in Pharmacovigilance.

UNIT - V

Methods, ADR reporting and tools used in pharmacovigilance: International classification of diseases, International Nonproprietary names for drugs, Passive and Active surveillance, Comparative observational studies, Targeted clinical investigations and Vaccine safety surveillance. Spontaneous reporting system and Reporting to regulatory authorities, Guidelines for ADRs reporting. Argus, Aris G Pharmacovigilance, VigiFlow, Statistical methods for evaluating medication safety data.

REFERENCES:

• 1. Central Drugs Standard Control Organization- Good Clinical Practices, Guidelines for Clinical Trials on Pharmaceutical Products in India. New Delhi: Ministry of Health;2001.
• 2. International Conference on Harmonization of Technical requirements for registration of Pharmaceuticals for human use. ICH Harmonized Tripartite Guideline. Guideline for Good Clinical Practice.E6; May 1996.230
• 3. Ethical Guidelines for Biomedical Research on Human Subjects 2000.Indian Council of Medical Research, New Delhi.
• 4. Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan Green, March 2005, John Wiley and Sons.
• 5. Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs. Second Edition, Jan 2000, Wiley Publications.
• 6. Handbook of clinical Research. Julia Lloyd and Ann Raven Ed. Churchill Livingstone.
• 7. Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna and Haynes.
• 8. Textbook of Pharmacovigilance: Concept and Practice. G.P. Mohanta and P. K. Manna. 2016, PharmaMed Press.
• 9. A textbook of Clinical Pharmacy Practice: Essential Concepts and Skills. Second Edition, 2012, University Press M.Pharm I Year II Sem (Industrial Pharmacy)