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Syllabus – Clinical Research and Pharmacovigilance

CLINICAL RESEARCH

Section – 1  Introduction of Clinical Research
Chapter – 1 Introduction of Clinical Research
Chapter – 2 Clinical Trial Phases
Chapter – 3 Pharmacological Principal Of Clinical Research
Chapter – 4 Drug Development And Launch

Section – 2 Indian Regulation (domestic regulation)
Chapter – 1 ICH GCP
Chapter – 2 Schedule Y
Chapter – 3 ICMR
Chapter – 4 Indian GCP

Section – 3 key Stakeholders in Clinical Research
Chapter – 1 Ethics Committees And Institutional Review Board
Chapter – 2 Responsibilities Of Sponsor
Chapter – 3 Responsibilities Of Investigator
Chapter – 4 Responsibilities Of Sponsor – Investigator
Chapter – 5 Responsibilities Of Sponsor – Vendor

Section – 4 Clinical Trial Design and Project Managements
Chapter – 1 Clinical Trial Design
Chapter – 2 Vendor Selection And Managements
Chapter – 3 Project Planning
Chapter – 4 Project Managements

Section – 5 Principles of Good Clinical Practices
Chapter – 1 Protocol Design
Chapter – 2 CRF Design

Section – 6 Essential documents in Clinical Research and Regulatory Requirements
Chapter – 1 Essential Documents
Chapter– 2 IND Application
Chapter – 3 Clinical Study Report
Chapter – 4 NDA Application
Chapter – 5 Informed Consent process And Documentation

Section – 7 Study Setup Process
Chapter – 1 Site Selection And Pre- Study VIsits
Chapter – 2 Site Initiation
Chapter – 3 Subject Recruitment And Retention Planning
Chapter – 4 Site Contract And Budgeting

Section – 8 QC, Compliance & Auditing in Clinical Research
chapter – 1 21 CRF Part 11
Chapter – 2 Site Auditing
Chapter – 3 Sponsor Compliance And Auditing
Chapter – 4 SOP For Clinical Research

Section – 9 Clinical Monitoring
Chapter – 1 CRF Review & Source Data Verification
Chapter – 2 Drug Safety Reporting
Chapter – 3 Drug Accountability Work
Chapter – 4 Routine Site Monitoring
Chapter – 5 Site Close Out Visit

PHARMACOVIGILANCE

Section – 1 Introduction of Pharmacovigilance
Chapter – 1 Overview Of Pharmacovigilance
Chapter – 2 Standard Terms And Terminology In Pharmacovigilance

Section – 2 Medical Evaluation Of Adverse Events In Pharmacovigilance
Chapter -1 Adverse Event Reporting System And Form
Chapter – 2 Diagnosis And Managements Of ADRs
Chapter – 3 Medical Evaluation Of AE

Section – 3 Case Processing
Chapter – 1 Global Perspective Of Pharmacovigilance
Chapter – 2 Single Case Processing
Chapter – 3 Case Narrative Writing

Section – 4 Pharmacovigilance Reporting Database , Signal Detection , Managements And Risk Assessments & Evaluation
Chapter – 1 Quality System In PV
Chapter -2 Expedited Reporting Criteria
Chapter -3 PSUR & PBRER
Chapter – 4 PV Database And Signal Detection
Chapter – 5 Risk Assessments & Managements

Section – 5 Medical Dictionary For Regulatory Activities medDRA
Chapter – 1 medDRA

Section – 6 PV laws And Guideline
Chapter – 1 Regulatory Guideline & Laws In PV
Chapter – 2 SOPS In PV
Chapter – 3 PV Auditing And Inspection
Chapter – 4 Regulatory Aspects In PV