Course Outline
Introduction
Overview of Various Clinical Research Types and the Corresponding GCP Focus Areas
- GCP for Clinical Trials Involving Investigational Drugs and Medical Devices (Based on U.S. FDA Regulations)
- GCP for Clinical Investigations of Devices
- GCP for Clinical Trials Involving Investigational Drugs and Biologics
- (ICH-Based Standards)
- 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
Distinctions Between ICH GCP E6 Standards and U.S. FDA Regulations
The Investigator's Role and Responsibilities in Clinical Trials
Industry Sponsors' Role and Responsibilities Under an Investigational New Drug (IND) Application
Informed Consent Requirements: Procurement and Documentation Procedures
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
Maintaining Data Quality Assurance and Integrity in Clinical Research
Designing and Conducting Clinical Trial Protocols
The Importance of Protocol Compliance in Clinical Trials
Clear Documentation and Record-Keeping in Clinical Trials
Preparing for and Undergoing Clinical Trial Audits and Inspections
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