HOW TO READ DATA
The ICH E6(r3) Interactive Visualizer distils the Step 4 guideline into an immersive narrative that spotlights how Good Clinical Practice evolves under the new framework. Rather than plotting third-party statistics, each chart interprets the wording of the core document so stakeholders can align on intent and practical impact.
Every section is anchored in the guideline language or its Quality-by-Design companion materials. Use the visuals as a reading aid for the publication:
Colour cues remain consistent: deep blue denotes long-standing GCP foundations, orange highlights new or proactive behaviours, and green signals adaptive, risk-based practices. Whenever percentages appear, they are illustrative weightings derived from the emphasis placed within the text—not from external operational data.
Source: International Council for Harmonisation. ICH E6(R3) Guideline for Good Clinical Practice, Step 4, 6 January 2025. All interpretations within the visualiser reference this publication and Cyntegrity explanatory material.
Every section is anchored in the guideline language or its Quality-by-Design companion materials. Use the visuals as a reading aid for the publication:
- Vision and 12 Principles: The hero banner and principle cards summarise the foundational statements that define GCP under R3. Each card mirrors a principle headline and a succinct interpretation for quick recall.
- Timeline milestones: The horizontal timeline frames R3 within historical ethics milestones. Hover to reveal the description paraphrased from the original codes and previous ICH revisions.
- Evolution cards and paradigm chart: Side-by-side bullet lists compare legacy R2 practices with the R3 mindset, while the doughnut chart highlights the proportional shift from prescriptive to proactive quality strategies.
- Focus radar: A normalised 0–100 scale contrasts emphasis areas (quality, proportionality, technology, data governance, prescriptive rules) to show how R3 redistributes attention. Higher values mean greater prominence in R3 language.
- Quality-by-Design cycle: Clickable tiles walk through the five recommended QbD steps. Selecting a tile spotlights where each step sits in the continuous feedback loop described in the annexes.
- CRA dashboard: Three Chart.js panels translate narrative guidance on risk-based monitoring into indicative percentage shifts. Bars and doughnuts use relative effort (0–100%) to contrast traditional workflows with R3-aligned priorities.
- Benefits chart: Horizontal bars capture the qualitative impact on key stakeholder groups. Scores are expressed as percentages to emphasise the comparative uplift outlined in the adoption guide.
Colour cues remain consistent: deep blue denotes long-standing GCP foundations, orange highlights new or proactive behaviours, and green signals adaptive, risk-based practices. Whenever percentages appear, they are illustrative weightings derived from the emphasis placed within the text—not from external operational data.
Source: International Council for Harmonisation. ICH E6(R3) Guideline for Good Clinical Practice, Step 4, 6 January 2025. All interpretations within the visualiser reference this publication and Cyntegrity explanatory material.
