Post Graduate Diploma in Clinical Trials Management

Global Institute of Health Science is a pioneer in health science education especially in distance & online education. Global Institute of Health Science is the INDIA’s first Online Institute and an ISO 9001:2008 Certified health science Institute, also certified with copyright approval from MHRD (Higher Education) Government of INDIA. GIHS have certification from UK for Quality Control Management System.

Syllabus

Clinical Trails Management

· Introduction of clinical research

Clinical Trial Phases

Pharmacological Principal Of Clinical Research

Drug Development And Launch

· Indian Regulation (domestic regulation)

ICH GCP
Schedule Y
ICMR
Indian GCP

· Key Stakeholders In Clinical Research
Ethics Committees And Institutional Review Board
Responsibilities Of Sponsor
Responsibilities Of Investigator
Responsibilities Of Sponsor – Investigator
Responsibilities Of Sponsor – Vendor

· Clinical Trial Design And Project Managements
Clinical Trial Design
Vendor Selection And Managements
Project Planning
Project Managements

· Principles of good clinical practices
Protocol Design
CRF Design

· Essential documents in clinical research and regulatory requirements
Essential Documents
IND Application
Clinical Study Report
NDA Application
Informed Consent process And Documentation

· Study setup process
Site Selection And Pre- Study VIsits
Site Initiation
Subject Recruitment And Retention Planning
Site Contract And Budgeting

· QC, Compliance & Auditing in Clinical Research
21 CRF Part 11
Site Auditing
Sponsor Compliance And Auditing
SOP For Clinical Research

· Clinical Monitoring
CRF Review & Source Data Verification
Drug Safety Reporting
Drug Accountability Work
Routine Site Monitoring
Site Close Out Visit

· Introduction of Pharmacovigilance
Overview Of Pharmacovigilance
Standard Terms And Terminology In Pharmacovigilance

· Medical Evaluation Of Adverse Events In Pharmacovigilance
Adverse Event Reporting System And Form
Diagnosis And Managements Of ADRs
Medical Evaluation Of AE

· Case Processing
Global Perspective Of Pharmacovigilance
Single Case Processing
Case Narrative Writing

· Pharmacovigilance Reporting Database , Signal Detection , Managements And Risk Assessments & Evaluation
Quality System In PV
Expedited Reporting Criteria
PSUR & PBRER
PV Database And Signal Detection
Risk Assessments & Management

· Medical Dictionary For Regulatory Activities medDRA
medDRA

PV laws And Guideline
Regulatory Guideline @ Laws In PV
SOPS In PV
PV Auditing And Inspection
Regulatory Aspects In PV