Overview
Good Clinical Practice (GCP) is a set of guidelines for clinical research done on human subjects. GCP serves as the international standard for designing, conducting, monitoring, documenting, analyzing, and reporting clinical trials.
In this instructor-led, live training, participants will learn the most important guidelines and fundamental principles applied in Good Clinical Practice (GCP) for clinical trials and researches involving human subjects. This course provides an overview of the different GCP areas, but provides slightly more focus on the ICH-centric GCP for Investigational Drugs and Biologics.
By the end of this training, participants will be able to:
- Understand the fundamental principles of GCP for investigational drugs and biologics as based on the International Conference on Harmonization (ICH)
- Apply the guidelines stipulated by the GCP to their clinical researches and trials
Audience
- Clinical investigators
- Clinical research professionals
- Healthcare and medical professionals
- Clinical trials support staff
- Research and development staff
Format of the course
- Part lecture, part discussion, exercises and heavy hands-on practice
Requirements
- College degree in any field
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 Researches
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
Understanding the Role and Responsibilities of the Investigator in Clinical Trials
Understanding the Role and Responsibilities of Industry Sponsors in Clinical Trials Under an Investigational New Drug (IND) Application
Understanding Informed Consent Requirements and How to Obtain and Document Consent
Implementing Privacy Policies and Ensuring Confidentiality of Participants in Your Clinical Trials
Ensuring Participant Safety and Well-Being in Your Clinical Trials
Detecting, Evaluating, and Reporting Adverse Events in Your Clinical Trials
Conducting Data Quality Assurance and Integrity in Your Clinical Research
Designing and Conducting the Clinical Trial / Clinical Research Protocol
Understanding the Importance of Protocol Compliance in Your Clinical Trials
Conducting Clear and Proper Documentation and Record-Keeping in Your Clinical Trials
Understanding and Preparing for the Process of Audits and Inspections of Clinical Trials
Avoiding Research Misconduct
Recruiting and Retaining Participants for Your Clinical Trials
Crafting and Negotiating the Clinical Trial Agreement (CTA)
Summary and Conclusion