Course Outline
Introduction
Overview of Different Types of Clinical Research and GCP Focus Areas
- 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
Distinguishing Between ICH GCP E6 and U.S. FDA Regulations
The Role and Responsibilities of the Investigator in Clinical Trials
The Role and Responsibilities of Industry Sponsors in Clinical Trials Under an Investigational New Drug (IND) Application
Informed Consent Requirements: How to Obtain and Document 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 Ensuring Integrity in Clinical Research
Designing and Executing the Clinical Trial / Clinical Research Protocol
The Importance of Protocol Compliance in Clinical Trials
Clear Documentation and Record-Keeping in Clinical Trials
Preparing for and Undergoing 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 (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