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Course Outline

Introduction

Overview of Various Clinical Research Types and the Corresponding GCP Focus Areas

  • GCP for Clinical Trials Involving Investigational Drugs and Medical Devices (Based on U.S. FDA Regulations)
  • GCP for Clinical Investigations of Devices
  • GCP for Clinical Trials Involving Investigational Drugs and Biologics
  • (ICH-Based Standards)
  • 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

Distinctions Between ICH GCP E6 Standards and U.S. FDA Regulations

The Investigator's Role and Responsibilities in Clinical Trials

Industry Sponsors' Role and Responsibilities Under an Investigational New Drug (IND) Application

Informed Consent Requirements: Procurement and Documentation Procedures

Implementing Privacy Policies and Ensuring Participant Confidentiality in Clinical Trials

Ensuring 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 Clinical Trial Protocols

The Importance of Protocol Compliance in Clinical Trials

Clear Documentation and Record-Keeping in Clinical Trials

Preparing for and Undergoing Clinical Trial Audits and Inspections

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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