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Course Outline

Introduction

Overview of Various Types of Clinical Research and Identifying the GCP Focus in Each

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

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

Overview of the Role, Objectives, and Fundamental Requirements of the ICH E6 GCP Guidelines

Clarifying the Distinctions Between ICH GCP E6 and U.S. FDA Regulations

Understanding the Investigator's Role and Responsibilities in Clinical Trials

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

Comprehending Informed Consent Requirements and Techniques for Obtaining and Documenting Consent

Implementing Privacy Policies and Ensuring Participant Confidentiality in Clinical Trials

Prioritizing Participant Safety and Well-Being in Clinical Trials

Detecting, Evaluating, and Reporting Adverse Events in Clinical Trials

Ensuring Data Quality Assurance and Integrity in Clinical Research

Designing and Executing Clinical Trial / Clinical Research Protocols

Recognizing the Importance of Protocol Compliance in Clinical Trials

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

Understanding and Preparing for Clinical Trial Audits and Inspections

Preventing Research Misconduct

Strategies for 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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