Course Outline


Overview of the Different Types of Clinical Research and Understanding the GCP Focus in Each One

  • 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 Researches

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

Understanding the Difference 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 How to Obtain and Document Consent

Implementing Privacy Policies and Ensuring Confidentiality of Participants in Your Clinical Trials

Ensuring Participant Safety and Well-Being in Your Clinical Trials

Detecting, Evaluating, and Reporting Adverse Events in Your Clinical Trials

Conducting Data Quality Assurance and Integrity in Your Clinical Research

Designing and Conducting the Clinical Trial / Clinical Research Protocol

Understanding the Importance of Protocol Compliance in Your Clinical Trials

Conducting Clear and Proper Documentation and Record-Keeping in Your Clinical Trials

Understanding and Preparing for the Process of Audits and Inspections of Clinical Trials

Avoiding Research Misconduct

Recruiting and Retaining Participants for Your Clinical Trials

Crafting and Negotiating the Clinical Trial Agreement (CTA)

Summary and Conclusion


  • College degree in any field
  21 Hours

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