Advanced Clinical Research Auditing and Risk Management

This course provides an in-depth exploration of auditing principles, quality systems, and risk management in clinical research. It covers essential guidelines, regulatory compliance, and best practices to ensure integrity and quality in clinical investigations.

Module 1 : Investigational Product Development, the FDA, and Good

  • Clinical Practice Guidelines)” “Definitions
  • Investigational Product Development
  • Introduction to Good Clinical Practice (GCP)
  • Clinical Research Team Roles and Responsibilities
  • Informed Consent
  • Safety Management and Reporting
  • Investigational Product (IP) Accountability and Integrity
  • Source Documentation

Module 3 : Audit Planning and Execution in Clinical Research

  • Audit Types
  • Preparation for Audit
  • Audit Duration and Complexity
  • Audit Execution:
  • Additional Resources
  • Approach to consider site model of oversight

Module 5 : Risk-Based Auditing: Principles and Practices

  • Audit Focus
  • Risk Considerations
  • Risk Characteristics and Measures
  • Risk Acceptance and Assessment
  • Audit Planning and Execution
  • Risk-Based Auditing Factors
  • Continuous Improvement and Triggers
  • Responsibility for Risk

Module 2 : Clinical Audit Principles and Practices

  • Good Clinical Practice (GCP)
  • Auditor Selection and Qualification
  • Audit Professional Standards
  • Ethical Considerations
  • International Standards for Auditing
  • Difference Between Auditing and Monitoring
  • Quality Assurance (QA) vs. Quality Control (QC)
  • Case Studies

Module 4 : Quality Systems Auditing: Frameworks and Practices

  • Audit Types and Standards
  • Roles and Responsibilities
  • Quality System Regulations
  • Risk Management and Oversight
  • Specific Quality Systems
  • Standard Operating Procedures (SOP)
  • Approaches to Auditing
  • Inspectional Objectives

Module 6 :Clinical Investigator Audits: Processes and Compliance

  • Clinical Investigator and Sponsor Investigators
  • Purpose of clinical investigator audits
  • Auditing clinical investigators
  • Scope of the audit process
  • Appropriate tools for conducting clinical investigator audits
  • Quality Systems and Inspections for Clinical Investigator
  • Authority and Compliance of Clinical Investigator audits
  • Focus areas for Clinical Investigator Audit
  • Monitoring and Device Studies
  • International Inspections and Quality Systems

Certificate In FCPM [ Online ]

Duration : 4 hrs/ week (2 days/week)

Schedule : Session of 2 hours twice a week

Batches Starting From August 2024​

Enroll Now For Early Bird Offers ( 10% Discount In Both Modes )

Certificate In FCPM [ Offline ]

Duration : 4 hrs/ week (2 days/week)

Schedule : Session of 2 hours twice a week

Perks Of Offline Course

Role Play
Get to work on live projects
Face-to-face guidance by PM
Clinical on-site exposure