ICH E6(R3) Good Clinical Practice (GCP) Guidelines Revision Update

December 4, 2025: The U.S. Food and Drug Administration (FDA) has formally acknowledged and adopted the International Council for Harmonisation (ICH) E6(R3) “Good Clinical Practice” guidelines which went into effect in July 2025. The FDA published a final guidance on the guideline in the Federal Register in September 2025, confirming its adoption. This is a notification of updates which have been made to the following Biopharma Institute courses to incorporate these new guidelines:

• • GCP001 – GCP: ICH-GCP Good Clinical Practice
  • CP023a – Major Changes in GCP from ICH E6(R2) to (R3): Road Map (New course)
  • CP022a – Good Clinical Practice Training (GCP): ICH E6(R3) (New course)
  • CP024a – GCP Refresher Training: ICH E6(R3) (New course)
  • GCP004 – Clinical Trial Monitoring: Site Evaluation and Set-up
  • GCP005 – Clinical Trial Monitoring: Documentation and Closure
  • CT03A – GCP: ICH, Harmonization, and Principles of ICH E6(R3)
  • CT03B – GCP: Clinical Research Teamwork
  • CT03C – GCP: Clinical Trial GCP ICH E6(R3) Documentation and Data Governance
  • CT03D – GCP: Clinical Trial Sponsors GCP ICH E6(R3) Responsibilities
  • CT03E – GCP: Clinical Trial Investigators GCP ICH E6(R3) Responsibilities
  • CT03F – GCP: Informed Consent in Clinical Trials
  • CT03G – GCP: Clinical Trial Monitors GCP ICH E6(R3) Responsibilities

These courses have all been updated to reflect new GCP E6(R3) guidelines. The updates have been made to the courses delivered from Biopharma Institute’s learning management system (LMS), for our students, as well to the SCORM packages licensed by our clients. If you have a SCORM package, this will be automatically updated to the new version.

Dates these courses have been updated:

• GCP001 – GCP: ICH-GCP Good Clinical Practice
  • Updated: March 28^th, 2025 at 9:45am ET
• CT03A – GCP: ICH, Harmonization, and Principles
  • Updated: April 16^th, 2025 at 1:30pm ET
• CT03B – GCP: Clinical Research Teamwork
  • Updated: April 16^th, 2025 at 1:30pm ET
• CT03C – GCP: Clinical Trial GCP ICH E6(R3) Documentation and Data Governance
  • Updated: April 16^th, 2025 at 1:30pm ET
• CT03D – GCP: Clinical Trial Sponsors GCP ICH E6(R3) Responsibilities
  • Updated: April 16^th, 2025 at 1:30pm ET
• CT03E – GCP: Clinical Trial Investigators GCP ICH E6(R3) Responsibilities
  • Updated: April 16^th, 2025 at 1:30pm ET
• CT03F – GCP: Informed Consent in Clinical Trials
  • Updated: April 16^th, 2025 at 1:30pm ET
• CT03G – GCP: Clinical Trial Monitors GCP ICH E6(R3) Responsibilities
  • Updated: April 16^th, 2025 at 1:30pm ET
• GCP004 – Clinical Trial Monitoring: Site Evaluation and Set-up
  • Updated: June 18^th, 2025 at 1:15pm ET
• GCP005 – Clinical Trial Monitoring: Documentation and Closure
  • Updated: June 18^th, 2025 at 1:15pm ET

Reason for these Updates: The new ICH E6(R3) Good Clinical Practice (GCP) guidelines have been finalized and went into effect on July 23, 2025. The FDA has formally acknowledged the ICH E6(R3) Good Clinical Practice guidelines in September of 2025, confirming its adoption.

This revision change represents a significant modernization of the Good Clinical Practice (GCP) guideline, aiming to adapt to the evolving landscape of clinical trials, particularly with the rise of decentralized trials, digital technologies, and risk-based approaches. This update offers the most significant changes to Good Clinical Practice (GCP) guidelines within the past 10 years. Because of this, Biopharma Institute recommends that everyone working under these guidelines be trained on E6(R3) as soon as possible.

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More Information: ICH E6(R2) and ICH E6(R3) are both guidelines for good clinical practice (GCP) for clinical trials, but E6(R3) is more adaptable and risk-balanced.

ICH E6(R3) builds upon and refines the principles of ICH E6(R2) by introducing a more flexible, adaptable, and risk-based approach to clinical trials. E6(R3) emphasizes patient-centricity, supports decentralized and adaptive trial designs, and integrates real-world data and digital tools. It also enhances data integrity and traceability throughout the data lifecycle.

Here’s a more detailed comparison:
 

	ICH E6(R2):	ICH E6(R3):
Focus	Encourages technological advances	Promotes an agile framework
Approach	Tends toward excessive specificity	Emphasizes risk-based quality management
Changes	Adds more about document control	Redefines “errors” as “harms/hazards”
Other Features	Encourages innovative approaches to clinical trial design	Recognizes the increasing use of decentralized clinical trials

How do these guidelines help?

• They help ensure that clinical trials are conducted safely and ethically
• They help ensure that clinical trial data is mutually acceptable between ICH member countries
• They help ensure that clinical trials are designed to address potential sources of error or bias
• They help ensure that clinical trials are designed to proactively promote quality