MHRA CTU Inspections
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Hi all,
Please find attached a list of questions asked by the MHRA during an audit of the Glasgow Clinical Trials Unit in March 2017. The questions cover six areas:
- Overview of IVRS Build Process
- Overview of Computer System Validation (CSV) Processes
- IT Systems and Data Hosting
- Overview of eDC Build Process
- Overview of Interaction with Clients, Contracting and Project Management
- Quality System, Quality Assurance and Training
Regards
Louise
Louise Williams
UKCRC Registered CTU NetworkAttached Files:MHRA Inspection Questions Mar17.pdf (0 bytes)
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