MHRA Inspection Questions – March 2017

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 Network

 

 Attached Files:

MHRA Inspection Questions Mar17.pdf (0 bytes)

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