Program Structure

ADCR Consists of two modules:

Module A
Multimedia CD
Introduction to Clinical Trials
History of Clinical Research
General Pharmacology
Drug Development Process
Clinical Trial Design
ICH - GCP Guidelines
Schedule Y
Indian GCP Guidelines
Clinical Trials Protocol
Case Record From Design
Trial Master File
Data Management
Statistical Thinking for Clinical Trials
Assignment 1

Module B
Fundamentals of Monitoring and Site Management
Outsourcing in Clinical Research
Clinical safety & Pharmacovigilance
Indemnity & Liability in Clinical Trials
Fraud and Misconduct in Clinical Trials
Audit and Inspection
Quality Control and Quality Assurance
Ethics in Clinical Trials
Regulatory Affairs
Project Management
Principles of Pharmaco-economics
Introduction to Pharmacogenomics/Pharmacogenetics driven Clinical Trials
Introduction to CDISC
Assignment 2
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