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
Testimonials (3)
The Trainer was able to adapt to our ad-hoc questions really fast.
Pawel Kruszewski - Softsystem
Course - Genetic Sequencing and Testing
The accesibilit of the trainer and the ability to communicate very effective,
Ciprian Ilie - Institutul National de Sanatate Publica
Course - Programming for Biologists
practical applications from simple to complex