The Wizard's Library

Essential Knowledge for Clinical Trials & Risk-Based Thinking

eClinical Forum Audit Trail Review Paper (2021)
A foundational industry paper outlining the principles and practical use cases for effective audit trail review. Widely cited and used to guide RBQM and data integrity practices.

eClinical Forum Audit Trail Review Analytics (ATRA) Working Group
An active cross-industry group that builds on the ECF paper to prioritize audit trail use cases based on realized risk. Focused on enabling automation, data flow, and scalable analytics for audit trail review.

ICH E6(R3) – Good Clinical Practice Guideline (2025)

The latest GCP guideline from ICH, E6(R3) emphasizes risk-based quality management, audit trail analytics, and proportionate approaches to trial oversight. A must-read for understanding evolving regulatory expectations in modern clinical trials.

Wicked Problems (CogNexus)
Wicked problems are complex, shifting challenges with no single solution, no clear endpoint, and no definitive test of success. Each attempt to solve them changes the problem itself. This classic paper lays the foundation for understanding wicked problems—and why they require collaborative, adaptive, and systems-based approaches rather than linear thinking.

SCDM Position Paper – The Evolution of Clinical Data Management into Clinical Data Science (2022)
This position paper outlines the transformation of Clinical Data Management (CDM) into Clinical Data Science (CDS) —a strategic shift driven by decentralized trials, automation, and a growing focus on data quality over volume. It provides a roadmap for organizations to build CDS capabilities that are fit for modern, patient-centered, and risk-based clinical trials.

ICH E8(R1) – General Considerations for Clinical Studies (2021)
This updated guideline reframes quality in clinical trials by promoting a culture of trust, open dialogue, and critical thinking. It moves away from rigid, checklist-driven approaches, advocating instead for risk-proportionate planning and engagement of stakeholders, including patients. A foundational read for anyone designing studies with integrity, relevance, and operational excellence in mind.

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