ICH GCP E6(R3) online training program

Overview

With the official release and implementation of ICH GCP E6(R3), the quality

management philosophy in clinical trials is undergoing a profound transformation. Leveraging Parexel’s 40+ years of global clinical research experience and deep industry insights, we have developed the ICH GCP E6(R3) Online Training Program — a systematic, self-paced, and practical eLearning solution. This program equips clinical research professionals to quickly grasp the new regulations, integrate them seamlessly, and confidently enter the new era of clinical trials.

Key features:

Flexible and accessible: 90-minute self-paced online learning with pause-and-resume functionality
Systematic and comprehensive: A complete overview of ICH GCP E6(R3) core points, covering the full knowledge system from core principles to implementation
Interactive and innovative: Complex concepts simplified through real-world scenarios, animations, and videos, alongside interactive knowledge quizzes to reinforce learning
Expert-developed: Integrates deep insights and practical experience from Parexel’s internationally renowned clinical research experts
Industry-recognized: Earn a GCP certificate that meets TransCelerate mutual recognition standards

Course Description & Learning Outcomes

Program overview:

Module 1. Understanding ICH GCP E6(R3) core knowledge

Establishing the foundational concepts of the new guidelines

Guideline overview: Objectives, scope, and overall structure of ICH E6(R3)
Core principles explained: Interpretation of ICH E6(R3) fundamental principles and their impacts to clinical research
Compliance foundation: How all clinical research personnel can ensure adherence to ICH GCP standards

Module 2. ICH GCP E6(R3) advanced knowledge I

Mastering the core content of clinical trial management

Stakeholder responsibilities clarified: Roles and responsibilities of sponsors, investigators and ethics committees
Quality Management System: Concepts and practices, including Quality by Design, risk-based approaches, quality assurance and quality control
Scientific and ethical design: Core scientific and ethical considerations in study design
Delegation management mechanism: Authorization principles and implementation for trial-related activities

Module 3. ICH GCP E6(R3) advanced knowledge II

Focusing on key content for clinical trial implementation

Informed consent management: Regulatory requirements and implementation of the informed consent process
Data management and integrity: Data governance, blinding protection, essential records and source documentation
Participant safety protection: Participant medical care and safety event reporting
Protocol execution management: Maintaining protocol compliance and handling deviations
Investigational product management: Sponsor and Investigator responsibilities in investigational product oversight
Trial completion and follow-up: Post-trial processes, termination procedures and record retention

Benefits for participants:

Quickly grasp the core concepts and requirements of E6(R3), receiving clear guidance for daily operations

Strengthen compliance execution capabilities, ensuring all trial processes adhere to the latest global GCP standards
Master modern clinical trial management techniques to enhance overall trial quality,
efficiency and patient-centricity

Pre-course instructions

Who needs this training program?

Clinical trial site research personnel: Investigators, GCP office staff, ethics committee
members, clinical research coordinators, pharmacists and supporting site personnel
Pharmaceutical & biotech professionals: Clinical operations, medical affairs, biostatistics departments and related cross-functional teams

Schedule

Start Date: 28 Apr 2026, Tuesday
End Date: 31 Dec 2026, Thursday

This self-paced eLearning program provides essential education for clinical research staff, site personnel, and professionals working across the clinical research landscape.

Location: Online

Pricing

Course fees: Individual Price: $199 per person Group Discount: We offer special group discounts for orders of 10 or more participants. Please contact [email protected] for details.

Skills Covered

PROFICIENCY LEVEL GUIDE
Beginner: Introduce the subject matter without the need to have any prerequisites.
Proficient: Requires learners to have prior knowledge of the subject.
Expert: Involves advanced and more complex understanding of the subject.