Description
Good Clinical Practice training serves as the pre-requisite for any individual participating in clinical research at any level. Advantage Clinical has been a recognized and established GCP training provider since 2015. We have provided GCP training to tens of thousands of individuals globe. Our partnerships with leading sponsors, CROs and universities is a testament to the quality of the training we offer. We are proud to offer our Good Clinical Practice (GCP) training to individuals and teams in our web-based Learning Management System.
This course is written for GCP E6 R2. For Good Clinical Practice Training on the new R3 coming from ICH in Fall 2024 please click here.
Advantage Clinical’s Good Clinical Practice series goes beyond the guidance and provides students with real world applications and skills to apply GCP in their roles as clinical research professionals.
Within this GCP course we include role-based course branching, where students can focus on how GCP is applied to their particular role as a clinical research professional at your organization. This course includes pathways for:
Principal and Sub-Investigators
Clinical Research Coordinators
Clinical Support Staff
*For Sponsors and CROs please reach out to Advantage Clinical for a Sponsor / CRO specific course**
Module and Content Breakdown
• What is Good Clinical Practice
• History and Evolution
• ICH Parties and Goals of International Harmonization
• Why is GCP needed?
• Key Objectives
• Components of GCP
• Principles of GCP
• Institutional Review Board Responsibilities
• Investigator Responsibilities
• Sponsor Responsibilities
• Monitoring and Safety
• Clinical Trial Protocols and Amendments
• Essential Documents
This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. TransCelerate Biopharma is an industry body representing all of the major pharmaceutical and medical device trial sponsors.
Price: $99
If you are looking to train >1 person please reach out to us for enterprise pricing and course customizations to help craft this course to best suit your organization. Visit our contact page or email us at [email protected].
All of our course offerings are covered by our Customer Satisfaction Guarantee. If you are not satisfied with your purchase we will provide a full refund.
