Clinical Research and Pharmacovigilance

THEORY 1.

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 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 Hrs Hrs 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.

Hrs 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 programme, WHO and Regulatory terminologies of ADR, evaluation of medication safety, Establishing pharmacovigilance centres in Hospitals, Industry and National programmes related to pharmacovigilance.

Roles and responsibilities in Pharmacovigilance Hrs Methods, ADR reporting and tools used in Pharmacovigilance International classification of diseases, International Non- proprietary 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.

Hrs Pharmacoepidemiology, pharmacoeconomics, safety pharmacology Hrs