Emergency Code Break in Clinical Trials
The process for emergency code break within blinded clinical trials.
Emergency Code Break in Clinical Trials
The purpose of this SOP is to describe the process for emergency code break within blinded clinical trials. This SOP applies to all blinded clinical trials sponsored, co-sponsored, or managed by KHP Organisations.
The King’s Health Partners Clinical Trials Office has a Master Service Agreement with Emergency Scientific and Medical Services (ESMS) to provide emergency code break services for blinded clinical trials.
ESMS operate 24 hours a day, 365 days a year, and provide an emergency medical response service for blinded trials. Information Scientists at ESMS have immediate access to relevant study documentation, including blinded randomisation information.