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Course Outline

Introduction

Overview of Clinical Research Types and Understanding GCP Focus Areas

  • GCP for Clinical Trials Involving 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 Function of Institutional Review Boards (IRBs) in Clinical Trials and Research

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

Comparing ICH GCP E6 with U.S. FDA Regulations

Clarifying the Investigator's Role and Responsibilities in Clinical Trials

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

Mastering Informed Consent Requirements and Procedures for Obtaining and Documenting Consent

Implementing Privacy Policies and Maintaining Participant Confidentiality in Clinical Trials

Ensuring Participant Safety and Well-Being in Clinical Trials

Detecting, Evaluating, and Reporting Adverse Events in Clinical Trials

Conducting Data Quality Assurance and Ensuring Data 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

Preparing for and Navigating Clinical Trial Audits and Inspections

Preventing Research Misconduct

Strategies for Recruiting and Retaining Participants in Clinical Trials

Drafting and Negotiating Clinical Trial Agreements (CTA)

Summary and Conclusion

Requirements

  • A college degree in any discipline
 21 Hours

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