Course Outline
Introduction
Overview of Clinical Research Types and GCP Focus Areas
- GCP for Clinical Trials with Investigational Drugs and Medical Devices (based on U.S. FDA regulations)
- GCP for Clinical Investigations of Devices
- GCP for Clinical Trials with Investigational Drugs and Biologics
- (Based on ICH 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
Distinction Between ICH GCP E6 and U.S. FDA Regulations
Understanding the Investigator’s Role and Responsibilities 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 Methods 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 Maintaining Integrity in Clinical Research
Designing and Conducting the Clinical Trial/Clinical Research Protocol
Understanding the Importance of Protocol Compliance in Clinical Trials
Executing Clear and Proper Documentation and Record-Keeping in Clinical Trials
Preparing for and Understanding the Process of 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
Testimonials (1)
The Trainer was able to adapt to our ad-hoc questions really fast.
