Length: 2 Days
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Fundamentals of Good Clinical Practices (GCP) Training by Tonex

This course provides a thorough understanding of Good Clinical Practices (GCP) in clinical research. It covers the ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve the participation of human subjects.

Learning Objectives:

  • Understand the principles of Good Clinical Practices (GCP).
  • Analyze the ethical considerations in clinical research.
  • Evaluate the regulatory requirements for clinical trials.
  • Assess the roles and responsibilities of clinical trial stakeholders.
  • Explore the documentation and reporting standards in GCP.
  • Develop strategies for ensuring compliance with GCP.

Audience:

  • Clinical research professionals
  • Regulatory affairs specialists
  • Investigators and study coordinators
  • Clinical trial auditors
  • Medical and healthcare professionals

Program Modules:

Module 1: Introduction to Good Clinical Practices (GCP)

    • Overview of GCP principles
    • Historical development of GCP
    • Key ethical and scientific standards
    • Role of GCP in clinical research
    • Case studies of GCP applications
    • Future trends in GCP

Module 2: Ethical Considerations in Clinical Research

    • Informed consent process
    • Protection of human subjects
    • Ethical review by Institutional Review Boards (IRBs)
    • Risk-benefit assessment
    • Case studies of ethical issues
    • Ethical guidelines and frameworks

Module 3: Regulatory Requirements for Clinical Trials

    • Overview of regulatory bodies
    • Key regulatory requirements (FDA, EMA, ICH)
    • Clinical trial application process
    • Regulatory inspections and audits
    • Case studies of regulatory compliance
    • Future trends in clinical trial regulation

Module 4: Roles and Responsibilities of Clinical Trial Stakeholders

    • Responsibilities of investigators
    • Role of sponsors and contract research organizations (CROs)
    • Duties of clinical trial monitors
    • Responsibilities of study coordinators
    • Case studies of stakeholder roles
    • Collaboration and communication in clinical trials

Module 5: Documentation and Reporting Standards in GCP

    • Essential documents in clinical trials
    • Source data verification and management
    • Case report forms (CRFs) and electronic data capture (EDC)
    • Adverse event reporting and management
    • Case studies of documentation practices
    • Best practices for data integrity and reporting

Module 6: Ensuring Compliance with GCP

    • Developing GCP compliance programs
    • Training and education for clinical research staff
    • Monitoring and auditing clinical trials
    • Risk management and quality assurance
    • Case studies of GCP compliance
    • Strategies for continuous improvement

 

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