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.