Clinical Research Internship Programme

SMO Business

Investigations
Course Curriculum
Other benefits
  • Eligibility : B.Pharm / M. Pharm / Life science/ Medical graduates and post graduates
  • Duration :  Months Theory + Internship (paid)
  • Placement : 100% placement assistance

Module 1: Introduction to Clinical Research

Module 2: Ethics and Guidelines in Clinical Research

Module 3: Roles & Responsibilities of Trial Personnel

Module 4: Introduction to Clinical Research Coordinator

Module 5: Essential Clinical Trial Documents

Module 6: Investigator Site Feasibility

Module 7: Site Budget, Payment Schedule & Negotiation

Module 8: Clinical Trial Agreement (CTA) & Negotiation

Module 9: Investigator Training Meeting

Module 10: Institutional Review Board (IRB) Submission

Module 11: Site Initiation Visit (SIV)

Module 12: Investigator Site File (ISF)

Module 13: Clinical Trial Registration

Module 14: Procurement

Module 15: Subject Screening, ICD, Recruitment & Safety

Module 16: Source Documentation

Module 17: Case Report Form (CRF) & Data Entry

Module 18: Safety Reporting & Management

Module 19: Monitoring Visit

Module 20: Audit & Inspection

Module 21: Investigational Product (IP) Management

Module 22: Financial Management

Module 23: Communication, Coordination & Compliance

Module 24: Site Closeout Visit

Module 25: Site Closeout Activities

  • Digital Notes
  • Industry Based Learning
  • Live Interactive Sessions
  • 100% Internship & Placement Assistance

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