Course Features:
About 50 hours of Instructor led-Online Training course, can introduce life science
bachelors to evergreen and booming clinical research industry

Course Objectives:
To deliver a high-end training to provide participants, a broad understanding of the basic
and advanced principles employed in clinical research and to develop experts/skilled
professionals thereby enhancing the employment prospects of the candidates in Pharma,
Biotech, Clinical research Industry

Course Outline:
 Introduction to Clinical Research

• Clinical Trial Terminologies
• Drug Discovery  Development
• CPCSEA Guideline & Pre-clinical Trials
• Introduction to Toxicity Studies
• Definition of clinical trial
• History of Clinical research
• Different Phases of clinical research
• Sub-types of Phase 1,2 and 3
• Phase 4
• Bio-availability & Bio-equivalence Studies [BA/BE]
• E –clinical trial
   

Drug Regulations Ethics in Clinical Research

•  Background of ethics
• Nuremberg code
• Declaration of Helsinki
• Belmont Report
• Informed consent Process
• History of Indian regulations
• Schedule–Y-Appendices
• ICMR Guidelines
• Indian GCP
• ICH GCP
• Drugs & magic remedies Act 1954
• Drug prices control order
• Regulations for AYUSH
• CTRI-Clinical trial registry of India
  
  

Clinical Trial Documentation, Audits and Inspections

• Different types of trial design
• Clinical trial documents
• Definition responsibility of Principal Investigator
• Audit & inspections
• Role of Clinical Research Organization, Site Management and Monitoring in
  Clinical Research
• The Definition & responsibilities and duties of Principal Investigator
• Objectives of a Clinical Research Organization
• Role of a Clinical Research Organization
• Role of personnel in a clinical trial
  
  

Clinical Trial Documentation, Audits and Inspections.

• Clinical trial documents
• Definition & responsibility of Principal Investigator
• Audit  inspections
• Different types of trial design
• Role of Clinical Research Organization, Site Management and Monitoring in 
  Clinical Research
• Objectives of a Clinical Research Organization
• The Definition  responsibilities and duties of Principal Investigator
• Role of personnel in a clinical trial
  
  

 An Introduction to Clinical Data Management

• Data Management Standards
• Set-Up
• CDMS & CTMS
• Conduct
• Medical coding / Writing
• Close Out
• Pharmacovigilance
• Assignments and other Activities.