ICH GCP E6(R3)

The final version of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) E6(R3) was adopted on 06 January 2025. The guideline has been restructured from the previous version E6 (R2). E6(R3) Section 4 (Data Governance - Investigator and Sponsor) now includes data governance, data lifecycle, and computerised systems.

GAMP CoP UK Forum

It was great to see everyone at the GAMP CoP UK Forum, 19-Nov-2024 in Stevenage. Topics included an Interactive Session - Slipping through the gaps: How do defects escape into the wild?, Disaster Recovery - Cybersecurity, Data Lakes & Analytics, a panel discussion on AI - Do You Know Where It is Being Used and What For?, Transforming Patient Engagement with Critical Medical Information, and a Good Practice Guide Update including alignment with GAMP 5, 2nd Edition.

ISPE GAMP Good Practice Guide: Good eClinical Practice

Validation and Compliance of Computerized GCP Systems and Data, second edition has been published by the ISPE. The guide covers a process overview and process model of GCP systems, data integrity, data privacy in clinical trials, decentralized clinical trials, assessment of clinical trial site systems, good clinical laboratory practice, use of data science and AI-enabled systems in clinical trials, real-world data/real-world experience, and open-source software in clinical trials. You can buy your copy from the ISPE website.