Course Outline
Introduction
Overview of Various Clinical Research Types and Corresponding 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 Involving 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
Understanding the Distinction 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
Understanding Informed Consent Requirements and Procedures for Obtaining and Documenting Consent
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
Conducting Data Quality Assurance and Integrity in Clinical Research
Designing and Conducting the Clinical Trial/Clinical Research Protocol
Understanding the Importance of Protocol Compliance in Clinical Trials
Conducting Clear and Proper Documentation and Record-Keeping in Clinical Trials
Understanding and Preparing for Clinical Trial Audits and Inspections
Avoiding Research Misconduct
Recruiting and Retaining Participants for Clinical Trials
Crafting and Negotiating the Clinical Trial Agreement (CTA)
Summary and Conclusion
Requirements
- A college degree in any discipline
