Course Outline
Introduction
Overview of Various Types of Clinical Research and Identifying the GCP Focus Areas Within 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 with Investigational Drugs and Biologics
- (ICH-Based)
- GCP for Social and Behavioral Clinical Research
Comprehending Ethical Standards and the Role of Institutional Review Boards (IRBs) in Clinical Trials and Research
Overview of the Purpose, Role, and Fundamental Requirements of the ICH E6 GCP Guidelines
Distinguishing Between ICH GCP E6 and U.S. FDA Regulations
Defining the Role and Responsibilities of the Investigator in Clinical Trials
Defining the Role and Responsibilities of Industry Sponsors in Clinical Trials Under an Investigational New Drug (IND) Application
Mastering Informed Consent Requirements and Techniques for Obtaining and Documenting Consent
Implementing Privacy Policies to Ensure Participant Confidentiality in Clinical Trials
Safeguarding Participant Safety and Well-Being in Clinical Trials
Identifying, Evaluating, and Reporting Adverse Events in Clinical Trials
Ensuring Data Quality Assurance and Integrity in Clinical Research
Designing and Executing the Clinical Trial or Research Protocol
Recognizing the Importance of Protocol Compliance in Clinical Trials
Maintaining Clear and Proper Documentation and Record-Keeping in Clinical Trials
Preparing for and Navigating the Process of Audits and Inspections of Clinical Trials
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
Testimonials (1)
The Trainer was able to adapt to our ad-hoc questions really fast.
