This document has been developed by the NHS Quality Assurance Committee and National Pharmacy Clinical Trials Advisory Group with input provided by the MHRA Clinical Trial Unit, GMP and GCP Inspectorates. This document is intended to complement existing legislation and guidance and reflects current thinking. The contents of this document do not replace existing requirements. Users of this document should be aware that this document has no legal status and may be affected by future changes in legislation and guidance.
Version 2 – amended for addition of clarification regarding blinding