Course Outline
Introduction
Overview of Various Types of Clinical Research and Identifying the GCP Focus in 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 Involving 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, Objectives, and Fundamental Requirements of the ICH E6 GCP Guidelines
Clarifying the Distinctions Between ICH GCP E6 and U.S. FDA Regulations
Understanding the Investigator's Role and Responsibilities in Clinical Trials
Understanding Industry Sponsors' Role and Responsibilities in Clinical Trials Under an Investigational New Drug (IND) Application
Comprehending Informed Consent Requirements and Techniques for Obtaining and Documenting Consent
Implementing Privacy Policies and Ensuring Participant Confidentiality in Clinical Trials
Prioritizing Participant Safety and Well-Being in Clinical Trials
Detecting, Evaluating, and Reporting Adverse Events in Clinical Trials
Ensuring Data Quality Assurance and 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
Understanding and Preparing for Clinical Trial Audits and Inspections
Preventing Research Misconduct
Strategies for 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