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Course Outline

Introduction

Overview of Various Clinical Research Types and the Specific GCP Focus for Each

  • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA-Based)
  • GCP for Clinical Investigations of Devices
  • GCP for Clinical Trials with Investigational Drugs and Biologics
  • (ICH-Based)
  • GCP for Social and Behavioral Clinical Research    

Understanding Ethics and the Role of Institutional Review Boards (IRBs) in Clinical Trials and Research

Overview of the Role, Purpose, and Basic Requirements of the ICH E6 GCP Guidelines

Distinguishing Between ICH GCP E6 and U.S. FDA Regulations

Understanding the Role and Responsibilities of the Investigator in Clinical Trials

Understanding the Role and Responsibilities of Industry Sponsors in Clinical Trials Under an Investigational New Drug (IND) Application

Understanding Informed Consent Requirements and Methods for Obtaining and Documenting Consent

Implementing Privacy Policies and Ensuring Participant Confidentiality in Clinical Trials

Safeguarding Participant Safety and Well-Being in Clinical Trials

Detecting, Evaluating, and Reporting Adverse Events in Clinical Trials

Maintaining Data Quality Assurance and Integrity in Clinical Research

Designing and Conducting the Clinical Trial / Clinical Research Protocol

Appreciating the Importance of Protocol Compliance in Clinical Trials

Executing Clear and Proper Documentation and Record-Keeping in Clinical Trials

Preparing for Audits and Inspections of Clinical Trials

Preventing Research Misconduct

Recruiting and Retaining Participants for Clinical Trials

Drafting and Negotiating the Clinical Trial Agreement (CTA)

Summary and Conclusion

Requirements

  • A college degree in any discipline
 21 Hours

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