A great overview of GCP and practical clinical trial data issues.
This is an essential read for clinical data management teams. It covers the key ICH GCP E6(R2) requirements relevant to members
of the data management team and provides valuable practical advice. Content is based on an overall GCP checklist and provides detail on staff qualifications and training, clinical data management processes, computerized systems, data flows, standards for source data, quality checks, documentation, outsourcing and risk-based approaches.
Authors: Mark Elsley,
Prof Dr David Hutchinson
Price Band: D