Course Introduction

The Introduction to Clinical Research suite of online modules is designed to train research site staff in role-based courses. These roles include allied health staff, ancillary staff, patient care staff, financial staff and clinical research staff in the basic competencies of clinical research. 

Course Syllabus:

Introduction to 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 Management

  •  Clinical Trial Design
  •  Vendor Selection And Management
  •  Project Planning
  • Project Management

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
  • Chapter – 5 Site Close Out Visit

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