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A brand new book for data management teams. Written by experienced head of data management, Mark Elsley, in conjunction with Professor David Hutchinson.
This book covers the key ICH GCP E6(R2) requirements relevant to members of the data management team. It also provides valuable practical advice gained from the author’s extensive experience in this field.
Content is based on a GCP checklist providing more detail on the following general requirements
• Ensure that staff are suitably qualified and trained
• Create, maintain and follow sops describing the clinical data management processes
• Validate and control all computerized systems used to collect and handle clinical data
• Ensure that the flow of data from the source to the database is well documented
• Ensure that source data meet ALCOA+ standards
• Create a user-friendly CRF and database
• Check CRF data for accuracy, consistency and completeness
• Produce, maintain and archive high-quality documentation
• Ensure that CROs are suitably qualified and experienced
• Use a risk register at functional and study level
• Have input into risk-based approaches to trial management
The book includes a GCP checklist for clinical data management