Course Outline
Introduction
Overview of the Different Types of Clinical Research and Understanding the GCP Focus in Each One
- GCP for Clinical Trials with 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 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 Difference Between ICH GCP E6 and U.S. FDA Regulations for Government
Understanding the Role and Responsibilities of the Investigator in Clinical Trials for Government
Understanding the Role and Responsibilities of Industry Sponsors in Clinical Trials Under an Investigational New Drug (IND) Application for Government
Understanding Informed Consent Requirements and How to Obtain and Document Consent for Government
Implementing Privacy Policies and Ensuring Confidentiality of Participants in Your Clinical Trials for Government
Ensuring Participant Safety and Well-Being in Your Clinical Trials for Government
Detecting, Evaluating, and Reporting Adverse Events in Your Clinical Trials for Government
Conducting Data Quality Assurance and Integrity in Your Clinical Research for Government
Designing and Conducting the Clinical Trial / Clinical Research Protocol for Government
Understanding the Importance of Protocol Compliance in Your Clinical Trials for Government
Conducting Clear and Proper Documentation and Record-Keeping in Your Clinical Trials for Government
Understanding and Preparing for the Process of Audits and Inspections of Clinical Trials for Government
Avoiding Research Misconduct for Government
Recruiting and Retaining Participants for Your Clinical Trials for Government
Crafting and Negotiating the Clinical Trial Agreement (CTA) for Government
Summary and Conclusion
Requirements
- A bachelor’s degree from an accredited institution is required for government positions.
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
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