ICH E6(r3) Interactive Visualizer

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Track how global GCP guidance evolved from the Nuremberg Code to today's agile quality standards. Explore how E6(R3) rebalances ethics, oversight, and technology so teams can design fit-for-purpose trials with confidence.

A New Era of Good Clinical Practice (GCP)

Visualizing the ICH E6 (R3) Guideline

ICH Vision

To provide a flexible framework that supports diverse clinical trial types and data sources while protecting participant safety and ensuring reliable results.

The 12 Principles of Good Clinical Practice

A refresh and expansion of the core tenets. Hover over a card to highlight it.

⚖️

1. Ethical Conduct

Trials must be conducted ethically, respecting scientific principles and the Declaration of Helsinki.

🩺

2. Favorable Benefit-Risk

Anticipated benefits must justify foreseeable risks and burdens for participants.

🛡️

3. Participant Rights & Well-being

The rights, safety, and well-being of participants are paramount.

📝

4. Informed Consent

Freely given informed consent should be obtained from every participant.

5. Reliable Information

Information generated must be reliable, high quality, and serve its intended purpose.

🎯

6. Clear Objectives

The protocol should be clear, concise, and designed to meet trial objectives.

👥

7. Defined Roles & Responsibilities

Roles and responsibilities of all parties must be clearly defined and documented.

🎓

8. Qualified Personnel

Individuals conducting a trial should be qualified by education, training, and experience.

🧠

9. Quality by Design

Quality should be built into the trial design and conduct from the start.

🛠️

10. Fit-for-Purpose Processes

Processes and data collection methods should be proportionate and suitable.

👁️

11. Appropriate Oversight

Oversight must be proportionate to the risks inherent in the trial.

🔗

12. Data Integrity & Traceability

Records should be accurate, complete, and contemporaneous for full traceability.

A Journey Through GCP Evolution

Milestones are summarised below; hover or focus to reveal deeper context for each turning point.

1947

Nuremberg Code

Code sets voluntary consent as a non-negotiable standard.

Nuremberg Code

Judges of the Doctors' Trial issued 10 principles after WWII, insisting on informed consent, scientifically sound design, and qualified personnel before human experimentation may proceed.

1964

Declaration of Helsinki

World Medical Association translates ethics into clinical research duties.

Declaration of Helsinki

Physicians adopted guidance that mandates independent review boards, clear risk-benefit evaluation, and special protection for vulnerable groups—creating the ethical backbone for modern trials.

1996

ICH E6 (R1)

ICH delivers the first unified GCP guideline across EU, Japan, and US.

ICH E6 (R1)

Regulators and industry harmonised expectations for protocols, investigator responsibilities, monitoring, and essential documents so multinational studies could follow one quality playbook.

2016

ICH E6 (R2)

Risk-based quality management and electronic records enter the framework.

ICH E6 (R2)

The addendum emphasised sponsor oversight of vendors, proportionate monitoring focused on critical data, and controls for electronic systems, marking the shift toward data-driven quality.

2023+

ICH E6 (R3)

Step 4 rewrite prioritises flexibility, QbD, and proportionate oversight.

ICH E6 (R3)

E6(R3) reframes GCP around critical-to-quality factors, modular requirements for diverse study designs, and adaptive governance that supports decentralised, digital, and real-world data trials.

Key Evolution from R2 to R3

The major shifts towards a more flexible and intelligent framework.

FROM: “One-Size-Fits-All” Approach

  • Rigid, checklist-based execution.
  • Intensive source data verification (SDV) for all data.
  • Reactive quality assurance.
  • Paper-based and traditional trial paradigms assumed.

TO: “Fit-for-Purpose” Mindset

  • Quality by Design (QbD): Proactively identify and protect “Critical to Quality Factors”.
  • Proportionate Risk Management: Scale monitoring and oversight based on specific risks.
  • Technology-Agnostic: Embraces digital health tech and innovative data sources.
  • Holistic Data Governance: Increased emphasis on the entire data lifecycle.

Visualizing the Paradigm Shift

This chart shows the shift from a prescriptive (R2) to a proactive (R3) framework. R3 prioritizes designing quality into processes from the start.

R2 vs. R3: Comparing Core Focus Areas

This interactive radar chart compares the focus of the old (R2) and new (R3) guidelines across key areas. R3 shows a clear evolution towards a more modern, risk-based approach.

The Quality by Design (QbD) Cycle

Click on a step to highlight it.

1

Identify Critical-to-Quality Factors

Endpoints, Safety, Inclusion/Exclusion

2

Identify & Evaluate Risks

Complex procedures, unreliable tools

3

Control Risks

Central monitoring, enhanced training

4

Communicate

Ensure all parties understand the plan

5

Review & Report

Continuously monitor risk controls

The Modern CRA Dashboard

Visualizing the impact of ICH E6 (R3) on clinical monitoring.

From Verifier to Quality Driver

ICH E6 (R3) transforms the role of the Clinical Research Associate from repetitive verification to strategic, risk-based oversight. The dashboard below highlights how monitoring activities evolve and where modern CRAs focus their attention.

Time on 100% SDV

-80%

A dramatic reduction in manual data verification unlocks time for proactive quality work.

Focus on Critical Data

+300%

More effort concentrates on protecting patient safety and safeguarding trial integrity.

Data-Driven Decisions

95%

Most monitoring actions are guided by central analytics and dynamic risk indicators.

Shift in Monitoring Activities

Effort moves away from exhaustive verification and toward targeted, insight-led interventions across core monitoring tasks.

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R3-Era Time Allocation

A look at how a modern CRA spends time once manual routines give way to collaboration, training, and analysis.

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Risk-Based Site Prioritization

Central monitoring produces risk scores so CRAs can prioritize follow-up where issues are most likely to occur.

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The Modern CRA Workflow

1. Review Central Analytics

Analyse consolidated risk indicators and emerging data trends from the central dashboard.

2. Prioritise Actions

Identify high-risk sites and critical data points that need focused intervention.

3. Conduct Targeted Follow-up

Apply remote or on-site monitoring that directly addresses the risks uncovered.

Benefits of Adopting ICH E6 (R3)

A significant win for the entire clinical research ecosystem.

The adoption of R3 principles creates a positive impact across the board. This chart represents the high level of benefit for key stakeholders, leading to a more efficient, safer, and innovative clinical trial environment.

ICH E6 (R3) is a modernization that equips clinical research for the 21st century.

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