Proportionality and Risk Assessment (Clinical Trials)
Proportionality ensures that clinical trial design, conduct, and oversight are aligned to participant risk and data importance.
Proportionality and Risk Assessment (Clinical Trials)
This SOP describes the procedures for applying proportionality and undertaking associated risk assessment during trial setup and delivery.
Proportionality should be applied during protocol development, reviewed and where necessary updated during trial delivery and documented in the Trial Master File (TMF).
This SOP applies to all CTIMPs sponsored by one or more of the King’s Health Partners (KHP) organisations and overseen by the KHP-CTO.