Knowledge Center – 2ucdm

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Key Industry Standards

ICH-GCP (International Council for Harmonisation – Good Clinical Practice)

ICH GCP Guidelines – ICHGCP
Record keeping, Quality & Integrity – ICH E6(R2) Guidelines
CDISC – Standards

Key Regulatory requirements

Food and Drug Administration

European Medicines Agency

EMA – Computerized Systems and Electronic Data Management in Clinical Trials
EMA – EMA Quality Guidelines

European Commission

Data Protection – GDPR

HIPAA (Health Insurance Portability and Accountability Act)

HIPAA and your Health Insights – HHS.gov
Health information Privacy – HIPAA Privacy Rule and Research
PHI Handling in Clinical Data Management – Protected Health Information Under HIPAA

Therapeutic Goods Administration

TGA – TGA’s Clinical Trials Guidelines

Emerging Trends

Risk Based Quality Management in Clinical Trials – EMA Reflection Paper on RBQM
AI in Drug development
The Role of Artificial Intelligence in Clinical Trial Design and Research – Q&A with FDA Podcast

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